AGENDA: Board of Health November 7, 2018 at 6:00 P.M. in the Mayor's Reception Room, 375 Merrimack St., 2nd floor, Lowell, MA 01852.

November 1, 2018

Michael Geary, City Clerk 375 Merrimack Street Lowell, Massachusetts 01852

Dear Mr. Geary: In accordance with Chapter 303 of the Acts of 1975 you are hereby notified that a meeting of the Lowell Board of Health will be held on Wednesday, November 7, 2018 @ 6:00 P.M. in the Mayor's Reception Room, 375 Merrimack St., 2nd floor, Lowell, MA 01852.

AGENDA:

1. New Business

1.I. For Acceptance: Minutes Of The October 3, 2018 Meeting Of The Board Of Health Motion: To approve and accept the minutes of the October 3, 2018 meeting of the Board of Health.

Documents:

BOH MINUTES - DRAFT OCTOBER 3, 2018 MEETING.PDF

1.II. For Review: Tobacco Control Monthly Report Submitted By Cesar Pungirum, Program Director.

Documents:

TOBACCO REPORT_OCT2018.PDF

1.III. Monthly Development Services Report Submitted By Senior Sanitary Code Inspector Shawn Machado.

Documents:

DEVELOPMENT SERVICES - RESTAURANT INSPECTION REPORT OCT 2018.PDF DEVELOPMENT SERVICES - NEW ESTABLISHMENTS OCTOBER 2018.PDF DEVELOPMENT SERVICES - FAILED RESTAURANT REPORT OCTOBER 2018.PDF DEVELOPMENT SERVICES - BODY ART OCTOBER INSPECTIONS FOR 11.7.18 MEETING.PDF

1.IV. Discussion: Health Code Violations In Lowell Public Schools

Documents:

LETTER TO CITY MANAGER EILEEN DONOGHUE OCTOBER 11, 2018.PDF LETTER TO ACTING SCHOOL SUPERINTENDENT JEANNINE DURKIN OCTOBER 11.2018.PDF

1.V. For Review: Trinity EMS, Inc Reports. Inclusive of Monthly Overdose Report(s) and Quarter 3 Report

Documents:

TRINITY EMS LOWELL OVERDOSE REPORTS 2018 SEPT.PDF TRINITY EMS Q3 2018 REPORT.PDF

1.VI. Informational: Article From JAMA August 28, 2018, Vol 320 Number 8 P769-778 "Effect of a Strategy of Initial Laryngeal Tube Insertion vs Endotracheal Intubation on 72-Hour Survival in Adults With Out-of-Hospital Cardiac Arrest. A Randomized Clinical Trial." Henry E. Wang, MD et. al. JAMA.2018;320(8):769-778. doi:10.1001/jama.2018.7044

Documents:

EFFECT OF A STRATEGY OF INITIAL LARYNGEAL TUBE INSERTION VS ENDOTRACHEAL INTUBATION OF 72-HOUR SURVIVAL IN ADULTS ....PDF

1.VII. Informational: Article From JAMA August 28, 2018 Vol. 320 Number 8 P779-791 "Effect of a Strategy of a Supraglottic Airway Device vs Tracheal Intubation During Out-of- Hospital Cardiac Arrest on Functional Outcome. The AIRWAYS-2 Randomized Clinical Trial." by Jonathan R. Benger, MD, et al. JAMA.2018;320(8):779-791. doi:10.1001/jama.2018.11597

Documents:

EFFECT OF A STRATEGY OF A SUPRAGLOTTIC AIRWAY DEVICE VS TRACHEAL INTUBATION DURING OUT-OF-HOSPITAL CARDIAC ARREST ON FUNCTIONAL OUTCOME.PDF

1.VIII. For Review: Board Of Health 2019 Meeting Schedule To discuss 2019 Board of Health Meeting schedule.

2. Old Business

2.I. For Review: Draft Letter Of Support RE: National Gas Pipelines Health Assessment Testing. Motion: To approve and sign/modify draft letter of support revised at October 3, 2018 Board of Health meeting.

Documents:

DRAFT - REVISED - LETTER OF SUPPORT REGARDING GAS PIPELINE HEALTH ASSESSMENT TESTING.PDF

3. Director's Report

3.I. Informational: Syringe Collection Program Coordinator

Documents:

SYRINGE COLLECTION PROGRAM COORDINATOR.PDF

3.II. Update: Divisional And Department Reports And Updates.

Documents:

PUBLIC HEALTH DIVISION REPORT -SEPTEMBER 2018.PDF SCHOOL HEALTH DIVISION REPORT - SEPTEMBER 2018.PDF SUBSTANCE ABUSE PREVENTION DIVISION REPORT - OCTOBER 2018.PDF

4. Motion: To Adjourn.

THE NEXT MEETING OF THE LOWELL BOARD OF HEALTH WILL BE HELD ON DECEMBER 5, 2018 AT 6:00 PM IN THE MAYOR'S RECEPTION ROOM. AGENDA: Board of Health November 7, 2018 at 6:00 P.M. in the Mayor's Reception Room, 375 Merrimack St., 2nd floor, Lowell, MA 01852.

November 1, 2018

Michael Geary, City Clerk 375 Merrimack Street Lowell, Massachusetts 01852

Dear Mr. Geary: In accordance with Chapter 303 of the Acts of 1975 you are hereby notified that a meeting of the Lowell Board of Health will be held on Wednesday, November 7, 2018 @ 6:00 P.M. in the Mayor's Reception Room, 375 Merrimack St., 2nd floor, Lowell, MA 01852.

AGENDA:

1. New Business

1.I. For Acceptance: Minutes Of The October 3, 2018 Meeting Of The Board Of Health Motion: To approve and accept the minutes of the October 3, 2018 meeting of the Board of Health.

Documents:

BOH MINUTES - DRAFT OCTOBER 3, 2018 MEETING.PDF

1.II. For Review: Tobacco Control Monthly Report Submitted By Cesar Pungirum, Program Director.

Documents:

TOBACCO REPORT_OCT2018.PDF

1.III. Monthly Development Services Report Submitted By Senior Sanitary Code Inspector Shawn Machado.

Documents:

DEVELOPMENT SERVICES - RESTAURANT INSPECTION REPORT OCT 2018.PDF DEVELOPMENT SERVICES - NEW ESTABLISHMENTS OCTOBER 2018.PDF DEVELOPMENT SERVICES - FAILED RESTAURANT REPORT OCTOBER 2018.PDF DEVELOPMENT SERVICES - BODY ART OCTOBER INSPECTIONS FOR 11.7.18 MEETING.PDF

1.IV. Discussion: Health Code Violations In Lowell Public Schools

Documents:

LETTER TO CITY MANAGER EILEEN DONOGHUE OCTOBER 11, 2018.PDF LETTER TO ACTING SCHOOL SUPERINTENDENT JEANNINE DURKIN OCTOBER 11.2018.PDF

1.V. For Review: Trinity EMS, Inc Reports. Inclusive of Monthly Overdose Report(s) and Quarter 3 Report

Documents:

TRINITY EMS LOWELL OVERDOSE REPORTS 2018 SEPT.PDF TRINITY EMS Q3 2018 REPORT.PDF

1.VI. Informational: Article From JAMA August 28, 2018, Vol 320 Number 8 P769-778 "Effect of a Strategy of Initial Laryngeal Tube Insertion vs Endotracheal Intubation on 72-Hour Survival in Adults With Out-of-Hospital Cardiac Arrest. A Randomized Clinical Trial." Henry E. Wang, MD et. al. JAMA.2018;320(8):769-778. doi:10.1001/jama.2018.7044

Documents:

EFFECT OF A STRATEGY OF INITIAL LARYNGEAL TUBE INSERTION VS ENDOTRACHEAL INTUBATION OF 72-HOUR SURVIVAL IN ADULTS ....PDF

1.VII. Informational: Article From JAMA August 28, 2018 Vol. 320 Number 8 P779-791 "Effect of a Strategy of a Supraglottic Airway Device vs Tracheal Intubation During Out-of- Hospital Cardiac Arrest on Functional Outcome. The AIRWAYS-2 Randomized Clinical Trial." by Jonathan R. Benger, MD, et al. JAMA.2018;320(8):779-791. doi:10.1001/jama.2018.11597

Documents:

EFFECT OF A STRATEGY OF A SUPRAGLOTTIC AIRWAY DEVICE VS TRACHEAL INTUBATION DURING OUT-OF-HOSPITAL CARDIAC ARREST ON FUNCTIONAL OUTCOME.PDF

1.VIII. For Review: Board Of Health 2019 Meeting Schedule To discuss 2019 Board of Health Meeting schedule.

2. Old Business

2.I. For Review: Draft Letter Of Support RE: National Gas Pipelines Health Assessment Testing. Motion: To approve and sign/modify draft letter of support revised at October 3, 2018 Board of Health meeting.

Documents:

DRAFT - REVISED - LETTER OF SUPPORT REGARDING GAS PIPELINE HEALTH ASSESSMENT TESTING.PDF

3. Director's Report

3.I. Informational: Syringe Collection Program Coordinator

Documents:

SYRINGE COLLECTION PROGRAM COORDINATOR.PDF

3.II. Update: Divisional And Department Reports And Updates.

Documents:

PUBLIC HEALTH DIVISION REPORT -SEPTEMBER 2018.PDF SCHOOL HEALTH DIVISION REPORT - SEPTEMBER 2018.PDF SUBSTANCE ABUSE PREVENTION DIVISION REPORT - OCTOBER 2018.PDF

4. Motion: To Adjourn.

THE NEXT MEETING OF THE LOWELL BOARD OF HEALTH WILL BE HELD ON DECEMBER 5, 2018 AT 6:00 PM IN THE MAYOR'S RECEPTION ROOM. AGENDA: Board of Health November 7, 2018 at 6:00 P.M. in the Mayor's Reception Room, 375 Merrimack St., 2nd floor, Lowell, MA 01852.

November 1, 2018

Michael Geary, City Clerk 375 Merrimack Street Lowell, Massachusetts 01852

Dear Mr. Geary: In accordance with Chapter 303 of the Acts of 1975 you are hereby notified that a meeting of the Lowell Board of Health will be held on Wednesday, November 7, 2018 @ 6:00 P.M. in the Mayor's Reception Room, 375 Merrimack St., 2nd floor, Lowell, MA 01852.

AGENDA:

1. New Business

1.I. For Acceptance: Minutes Of The October 3, 2018 Meeting Of The Board Of Health Motion: To approve and accept the minutes of the October 3, 2018 meeting of the Board of Health.

Documents:

BOH MINUTES - DRAFT OCTOBER 3, 2018 MEETING.PDF

1.II. For Review: Tobacco Control Monthly Report Submitted By Cesar Pungirum, Program Director.

Documents:

TOBACCO REPORT_OCT2018.PDF

1.III. Monthly Development Services Report Submitted By Senior Sanitary Code Inspector Shawn Machado.

Documents:

DEVELOPMENT SERVICES - RESTAURANT INSPECTION REPORT OCT 2018.PDF DEVELOPMENT SERVICES - NEW ESTABLISHMENTS OCTOBER 2018.PDF DEVELOPMENT SERVICES - FAILED RESTAURANT REPORT OCTOBER 2018.PDF DEVELOPMENT SERVICES - BODY ART OCTOBER INSPECTIONS FOR 11.7.18 MEETING.PDF

1.IV. Discussion: Health Code Violations In Lowell Public Schools

Documents:

LETTER TO CITY MANAGER EILEEN DONOGHUE OCTOBER 11, 2018.PDF LETTER TO ACTING SCHOOL SUPERINTENDENT JEANNINE DURKIN OCTOBER 11.2018.PDF

1.V. For Review: Trinity EMS, Inc Reports. Inclusive of Monthly Overdose Report(s) and Quarter 3 Report

Documents:

TRINITY EMS LOWELL OVERDOSE REPORTS 2018 SEPT.PDF TRINITY EMS Q3 2018 REPORT.PDF

1.VI. Informational: Article From JAMA August 28, 2018, Vol 320 Number 8 P769-778 "Effect of a Strategy of Initial Laryngeal Tube Insertion vs Endotracheal Intubation on 72-Hour Survival in Adults With Out-of-Hospital Cardiac Arrest. A Randomized Clinical Trial." Henry E. Wang, MD et. al. JAMA.2018;320(8):769-778. doi:10.1001/jama.2018.7044

Documents:

EFFECT OF A STRATEGY OF INITIAL LARYNGEAL TUBE INSERTION VS ENDOTRACHEAL INTUBATION OF 72-HOUR SURVIVAL IN ADULTS ....PDF

1.VII. Informational: Article From JAMA August 28, 2018 Vol. 320 Number 8 P779-791 "Effect of a Strategy of a Supraglottic Airway Device vs Tracheal Intubation During Out-of- Hospital Cardiac Arrest on Functional Outcome. The AIRWAYS-2 Randomized Clinical Trial." by Jonathan R. Benger, MD, et al. JAMA.2018;320(8):779-791. doi:10.1001/jama.2018.11597

Documents:

EFFECT OF A STRATEGY OF A SUPRAGLOTTIC AIRWAY DEVICE VS TRACHEAL INTUBATION DURING OUT-OF-HOSPITAL CARDIAC ARREST ON FUNCTIONAL OUTCOME.PDF

1.VIII. For Review: Board Of Health 2019 Meeting Schedule To discuss 2019 Board of Health Meeting schedule.

2. Old Business

2.I. For Review: Draft Letter Of Support RE: National Gas Pipelines Health Assessment Testing. Motion: To approve and sign/modify draft letter of support revised at October 3, 2018 Board of Health meeting.

Documents:

DRAFT - REVISED - LETTER OF SUPPORT REGARDING GAS PIPELINE HEALTH ASSESSMENT TESTING.PDF

3. Director's Report

3.I. Informational: Syringe Collection Program Coordinator

Documents:

SYRINGE COLLECTION PROGRAM COORDINATOR.PDF

3.II. Update: Divisional And Department Reports And Updates.

Documents:

PUBLIC HEALTH DIVISION REPORT -SEPTEMBER 2018.PDF SCHOOL HEALTH DIVISION REPORT - SEPTEMBER 2018.PDF SUBSTANCE ABUSE PREVENTION DIVISION REPORT - OCTOBER 2018.PDF

4. Motion: To Adjourn.

THE NEXT MEETING OF THE LOWELL BOARD OF HEALTH WILL BE HELD ON DECEMBER 5, 2018 AT 6:00 PM IN THE MAYOR'S RECEPTION ROOM.

October 3, 2018

A meeting of the Lowell Board of Health was held on Wednesday, October 3, 2108 in the Mayor's Reception Room, City Hall, 375 Merrimack St., Lowell, MA 01852. Chairwoman Jo-Ann Keegan called the meeting to order at 6:11 PM.

Present: Jo-Ann Keegan, RN, MSN, Chairperson John Donovan, DC, Board Member William Galvin, MD, Board Member Lisa Golden, RN, MSN, Board Member Kerran Vigroux, HHS Director Shawn Machado, Sr. Sanitary Code Inspector

10/3/18 MINUTES

1. New Business

1.I. For Acceptance: Minutes Of The September 5, 2018 Meeting Of The Board Of Health. The minutes of the September 5, 2018 meeting were reviewed by the Board

Motion: To accept the minutes made by Lisa Golden, seconded by William Galvin. All in favor.

1.II. Informational: Resignation of Kerry A. Hall from the Board of Health Effective September 14, 2018. Chairwoman Jo-Ann Keegan informed the Board of Ms. Hall’s resignation and the Manager’s plan to fill the position. The Board should let anyone interested know about the vacancy and that they should contact the Manager’s Office.

1. III. For Review: Tobacco Control Monthly Report Submitted By Cesar Pungirum, Program Director. The Board discussed the ticketing process and suspension of an establishment’s permit.

1. IV. For Review: Monthly Development Services Report Submitted By Shawn Machado, Sr. Sanitary Code Inspector. The Board reviewed the monthly reports. Discussion about the conditions of the Lowell Public Schools occurred.

Motion: To invite Acting Superintendent Jeannine Durkin, or her representative, to attend the November 7, 2018 Board of Health Meeting regarding ongoing school repairs made by William Galvin, seconded by Lisa Golden. All in favor.

1. V. For Review: Trinity EMS, Inc. Reports. The Board reviewed and placed on file.

2. OLD BUSINESS

2. I. For Review: Draft Letter of Support Re: Natural Gas Pipelines Health Assessment Testing. Motion: To approve and sign/modify draft letter of support. The Board reviewed the draft and requested modification to the third paragraph and final draft to be available for the November 7, 2018 meeting. Mr. Geoffrey Koetsch, Merrimack Valley Sierra Club Team Coordinator, provided an updated list of updated mailing addresses for the letter to be sent.

BOHM100318 Page 2

2. II. Update: Lowell Public School Repairs. Mr. James Donison, Commissioner of Public Works, was not available to provide an update.

2. III. Update: Service Zone Plan. Health and Human Services Director Kerran Vigroux updated the Board on the status of the Service Zone Plan which has been revised and resubmitted to Boston.

3. DIRECTOR’S REPORT

3.I. Update: Divisional and Department Reports and Updates. The Board reviewed and placed on file. Ms. Vigroux updated the Board on new/open positions in the Department, the CDC report on HIV cases, and the Needle Pick-up program being developed. Increases in Tuberculosis and Hepatitis cases were also discussed.

4. ADJOURNMENT

4. Motion: To Adjourn. Motion to adjourn at 6:57 PM made by William Galvin, seconded by John Donovan. All in favor.

THE NEXT MEETING OF THE CITY OF LOWELL BOARD OF HEALTH WILL BE HELD ON NOVEMBER 7, 2018 AT 6:00 PM IN THE MAYOR'S RECEPTION ROOM.

Prior Last Establishment # Street Inspection Inspector 2 Inspection Inspector-1 Seven Eleven 494 Bridge St. 03-Apr-18 Jimmy 18-Oct-18 Jimmy Rancho Tipico 11 Salem St. 17-Apr-18 Aurea 17-Oct-18 Aurea Veterans of Foreign Wars 190 Plain St. 30-Apr-18 Aurea 17-Oct-18 Aurea Gaelic American Club 255 Chelmsford St. 29-Jan-18 Aurea 17-Oct-18 Aurea Hispanic Domi Market 299 W Sixth St. 17-Apr-18 Dave/New 16-Oct-18 Aurea Manning's Liquor 427 Bridge St. 30-Apr-18 Jimmy 16-Oct-18 Jimmy Top Donut #2 603 Bridge St. 27-Apr-18 Jimmy 16-Oct-18 Jimmy American Legion Post 684 Westford St. 27-Mar-18 Aurea 16-Oct-18 Aurea Advance Auto 1647 Middlesex St. 28-Mar-18 Aurea 16-Oct-18 Aurea Powers Wine, Inc. 23 Wood St. 23-Apr-18 Jimmy 15-Oct-18 Jimmy Chuck E. Cheese 209 Plain St. 26-Apr-18 Aurea 15-Oct-18 Aurea Marshall's 211 Plain St. 26-Apr-18 Aurea 15-Oct-18 Aurea Bumi Pacific Liquors 421 Central St. 11-Apr-18 Lisa 15-Oct-18 Lisa Pais Family Fish Market 431 Central St. 10-Apr-18 Lisa 15-Oct-18 Lisa Donut Shack 487 Westford St. 09-Apr-18 Dave /Aurea 15-Oct-18 Aurea LePetit Club 660 Middlesex St. 23-Apr-18 Aurea 15-Oct-18 Aurea Dunkin Donuts 980 Chelmsford St. 27-Apr-18 Aurea 12-Oct-18 Aurea All Town 980 Chelmsford St. 27-Apr-18 Aurea 12-Oct-18 Aurea L&S Liquors 2 Dover St. 23-Apr-18 Aurea 11-Oct-18 Aurea Desert and Bakery Shop 32 Branch St. 15-Mar-18 Aurea 11-Oct-18 Aurea P&S Convenience Store 35 Willie St. 27-Apr-18 Aurea 11-Oct-18 Aurea Domino's Pizza 24-Apr-17 374 Chelmsford St. 18-Apr-18 Aurea 11-Oct-18 Aurea Sizzling Kitchen 478 Merrimack St. 25-Apr-18 Aurea 11-Oct-18 Aurea Pizza and Sub More 5 Merrimack St. 09-Mar-18 Lisa 10-Oct-18 Lisa Lemon Tree Food Shops, INC 220 Appleton St. 10-Oct-18 Shawn / New Wendy's 436 Chelmsford St. 19-Apr-18 Aurea 10-Oct-18 Aurea Jimmy's Pizza Too 480 Chelmsford St. 19-Apr-18 Aurea 10-Oct-18 Aurea Pub Ram @ Charlies's LLC 14 Cabot St. 17-Apr-18 Aurea 09-Oct-18 Aurea Pregnancy Care Center 158 Mammoth Rd 09-Oct-18 Shawn / New Rite Aid 276 Broadway St. 23-Apr-18 Aurea 08-Oct-18 Aurea Highland Liquors 12 Bridge St. 19-Mar-18 Lisa 05-Oct-18 Lisa Bany Restaurant Fail (11-Apr-17)(10-4-17) 681 Merrimack St. 17-Apr-18 Aurea 05-Oct-18 Aurea Kentucky Fried Chicken 1720 Middlesex St. 24-Apr-18 Aurea 05-Oct-18 Aurea China Star #2 1733 Middlesex St. 24-Apr-18 Aurea 05-Oct-18 Aurea Family Dollar 21 Nothingham St 17-Apr-18 Aurea 04-Oct-18 Auera I.S.S.O. 1705 Middlesex St. 04-Apr-18 Aurea 04-Oct-18 Aurea Priya Indian Cuisine 1290 Westford St. 20-Apr-18 Aurea 03-Oct-18 Aurea Halah Foods 1717 Middlesex St. 20-Apr-18 Aurea 03-Oct-18 Aurea Cowboy Café and Bakery 405 Lawrence St. 08-Feb-18 Lisa 02-Oct-18 Lisa Mill City BBQ 1018 Gorham St. 19-Jul-18 Lisa 02-Oct-18 Shawn Pho 88 1270 Westford St. 18-Apr-18 Aurea 02-Oct-18 Aurea Maruti Indian Grocery 1290 Westford St. 18-Apr-18 Jim 02-Oct-18 Aurea Highland Pizza & Seafood 1290 Westford St. 18-Apr-18 Aurea 02-Oct-18 Aurea Bambu 199 Plain St., #8 21-Mar-18 Dave / Aurea 01-Oct-18 Aurea Five Below 203 Plain St. 26-Apr-18 Aurea 01-Oct-18 Aurea Phnom Restaurant 309 Westford St. 20-Apr-18 Aurea 01-Oct-18 Aurea Middlesex Community College 33 Kearney Square 26-Jan-18 Jimmy 28-Sep-18 Jimmy Inn & Confrence Center 50 Warren St. 29-Mar-18 Adam 28-Sep-18 Jimmy Aramark Corp., ICC Dining Room 50 Warren St. 29-Mar-18 Adam 28-Sep-18 Jimmy Café Services, Inc. 100 Chelmsford St. 24-May-17 Aurea 28-Sep-18 Aurea CLOSED Grill Out 1 Solomont Way 27-Sep-18 Jimmy / New Subway @ Umass Lowell 1 Soloment way 20-Mar-18 Jimmy 27-Sep-18 Jimmy Prior Last Establishment # Street Inspection Inspector 2 Inspection Inspector-1 Starbuck's 1 Soloment Way 23-Mar-18 Jimmy 27-Sep-18 Jimmy Merrimack Market 1 Soloment way 20-Mar-18 Jimmy 27-Sep-18 Jimmy Transfiguration Church 25 Fr. John Sarantos Way 30-Mar-18 Adam 27-Sep-18 Jimmy Tmorda Sandwich Shop 35 Willie St. 12-Jul-18 Shawn 27-Sep-18 Shawn / NewMT Community Christian Fellowship 105 Princeton Blvd. 28-Mar-18 Aurea 27-Sep-18 Aurea Laura Lee School 235 Powell St. 17-Oct-17 Aurea 27-Sep-18 Aurea St Casimir Church 268 Lakeview Ave 27-Sep-18 Jimmy / New Einstein Brothers Bagels 1 University Ave. 23-Mar-18 Jimmy 26-Sep-18 Jimmy Aramark Southwick Food Court 1 University Ave 20-Mar-18 Jimmy 26-Sep-18 Jimmy South Campus Dining Center 1 Solomont Way 20-Mar-18 Jimmy 26-Sep-18 Jimmy Freshii 1 Soloment Way 20-Mar-18 Jimmy 26-Sep-18 Jimmy Huong Xuan V Store 63 Fletcher St. 29-Mar-18 Aurea 26-Sep-18 Aurea Holy Ghost Park 65 Village St. 30-Mar-18 Lisa 26-Sep-18 Lisa Lowell Transitional Living Center 189 Middlesex St. 26-Mar-18 Adam 26-Sep-18 Adam Athenian Corner 207 Market St. 27-Mar-18 Adam 26-Sep-18 Adam Yim's Convenience 742 Broadway St. 14-Mar-18 Aurea 26-Sep-18 Aurea Dunkin Donut 1081 Gorham St 21-Mar-18 Lisa 26-Sep-18 Lisa Kennedy's Butter & Egg 13 Merrimack St. 19-Mar-18 Lisa 25-Sep-18 Lisa Green Bamboo Chinese Rest. 14 Kearney Square 28-Mar-18 Lisa 25-Sep-18 Lisa Blue Taleh 15 Kearney Sq. 27-Mar-18 Lisa 25-Sep-18 Lisa Dunkin Donut 24 Merrimack St. 20-Mar-18 Lisa 25-Sep-18 Lisa Time Out Café & Eatery 72 Merrimack St. 28-Mar-18 Lisa 25-Sep-18 Lisa Two Chefs Are Better Than One 100 Chelmsford St 25-Sep-18 Shawn NEW El Potro Mexican Grill 124 Merrimack St. 27-Mar-18 Dave 25-Sep-18 Lisa Fabiano's 127 Merrimack St. 27-Mar-18 Lisa 25-Sep-18 Lisa Dunkin Donut 443 Chelmsford St. 28-Feb-18 Aurea 25-Sep-18 Aurea Rita Supermarket* 515 Lawrence St. 15-Aug-17 Lisa 25-Sep-18 Lisa Dunkin Donut 556 Dutton St. 27-Mar-18 Aurea 25-Sep-18 Aurea Amigo's Convience Meat Market 791 Central St. 27-Jun-18 Lisa 25-Sep-18 Lisa Fio's Express 1040 Gorham St 27-Mar-18 Lisa 25-Sep-18 Lisa The Open Pantry of Greater Lowell 13 Hurd St. 28-Mar-18 Lisa 24-Sep-18 Lisa Belvidere Wine Corp. 36 Concord St. 19-Mar-18 Lisa 24-Sep-18 Lisa V-Mart 123 Church st 27-Mar-18 Lisa 24-Sep-18 Lisa Salvation Army 150 Appleton St. 28-Mar-18 Lisa 24-Sep-18 Lisa UMASS Starbucks 220 Pawtucket St. 21-Mar-18 Jimmy 24-Sep-18 Jimmy UMASS Crossroads Café 220 Pawtucket St 19-Sep-17 Jimmy 24-Sep-18 Jimmy UMASS Bookstore 220 Pawtucket St 21-Mar-18 Jimmy 24-Sep-18 Jimmy OWL Diner 244 Appleton St. 21-Feb-18 Lisa 24-Sep-18 Lisa Cultures United 281 W. Sixth St. 29-Mar-18 Jimmy 24-Sep-18 Jimmy Lowell House of Pizza 283 School St. 26-Mar-18 Jimmy 24-Sep-18 Jimmy Lowell Assoc. 362 Fletcher St. 20-Mar-18 Jimmy 24-Sep-18 Jimmy St. Margaret's School 486 Stevens St. 03-Apr-18 Aurea 23-Sep-18 Aurea Lowel Catholic High School 530 Stevens St. 03-Apr-18 Aurea 23-Sep-18 Aurea Washington School 795 Wilder St. 01-May-18 Aurea 23-Sep-18 Aurea YMCA 35 YMCA Drive 27-Mar-18 Lisa 21-Sep-18 Lisa Pathfinders Group Home 94 Rock St. 21-Mar-18 Aurea 21-Sep-18 Aurea Lowell Day Nursery 119 Hall St. 30-Mar-18 Aurea 21-Sep-18 Aurea LBC Food Truck 143 Merrimack St 21-Sep-18 Jimmy NEW Dunkin Donut 145 Thorndike St. 27-Mar-18 Lisa 21-Sep-18 Lisa Dollar Tree * 169 Newwall St. 27-Mar-18 Lisa 21-Sep-18 Lisa Lowell Portuguse Bakery * 930 Gorham St 23-Mar-18 Lisa 21-Sep-18 Lisa Rogers School 43 Highland St. 23-Mar-18 Lisa 20-Sep-18 Lisa Prior Last Establishment # Street Inspection Inspector 2 Inspection Inspector-1 Pick Yourself Up 143 Central St. 28-Mar-18 Lisa 20-Sep-18 Lisa Moody School 158 Rogers St. 15-Mar-18 Lisa 20-Sep-18 Lisa Element Care 166 Central St. 28-Mar-18 Lisa 20-Sep-18 Lisa Gertrude Bailey School 175 Campbell Drive 04-Apr-18 Dave 20-Sep-18 Aurea Lincoln School 300 Chelmsford St. 29-Mar-18 Aurea 20-Sep-18 Aurea Active Day 345 Chelmsford St. 20-Feb-18 Aurea 20-Sep-18 Aurea Pawtucket Memorial School 425 West Meadow Rd. 22-Mar-18 Jimmy 20-Sep-18 Jimmy JJ Boomers 705 Pawtucket Blvd. 21-Mar-18 Adam 20-Sep-18 Adam New Food Establishments

Due 10/26/18

Meeting 11/7/18

LBC (Lowell Burger Company) Food Truck – 143 Merrimack St – 9/21/18 – Jimmy Le’s Food List.

Cowboy Café and Bakery – 405 Lawrence St – Lisa’s Food List

Grill Out – 1 Solomont Way – 9/27/18 Jimmy Le

St Casimir Church – 268 Lakeview Ave – 9/27/18 Jimmy Le

Lemon Tree Food Shops - 220 Appleton St – 10/10/18 Lisa’s food list

Two Chefs Are Better Than One – 100 Chelmsford St (corporate kitchen) Failed Restaurants

Due 10/26/18

Meeting 11/7/18

Rita’s Supermarket – 515 Lawrence St 9/25/18

No active servsafe – they were warned of it expiring six prior.

Selling moldy baked products

Selling expired can goods

Shelves need to be cleaned

Note: The food establishment was closed. Owner was cooperative. They cannot reopen until reinspection.

Reinspection: 4:30pm 9/25/18 – The shelves were cleaned and expired items removed – Grocery store is open – no prepared food is to be served.

Reinspection: 10/1/18 - Complied

Last three inspections: All Complied

Fio’s Express – 1040 Gorham St

Hood cleaning due

Reinspection: All Complied

Fitzy’s – 1250 Lawrence St 9/21/18

Hood cleaning due

Grease on stove/oven

Reinspection : 9/27/18 Complied

Last three inspections: All Complied

Desert Shop and Bakery – 32 Branch St 10/3/18

Refrigerators need cleaning

Clean and organize the establishment

Refrigerators leaking

Need pest control receipt

Reinspection: 10/11/18 Complied

Last three inspections: All Complied

OCTOBER 2018 BODY ART AND PIERCING INSPECTIONS FOR NOVEMBER 7, 2018 BOH MEETING

NAME OF BUSINESS DATE INSPECTED STATUS INSPECTED BY

Professional Body Piercing 10/18/18 PASSED Don Murphy 147 Central Street, Lowell

Lowell Ink 10/17/18 PASSED Don Murphy 161 Worthen Street, Lowell

Tierney’s Body Art 10/17/18 PASSED Don Murphy 12 Concord Street, Lowell

Blaq Sheep Tattoos 10/17/18 PASSED Don Murphy 564 Dutton Street 2nd Fl, Lowell

Lupo Ink 10/18/18 PASSED Don Murphy 1527 Middlesex St. #8, Lowell

Eileen Donoghue City Manager 375 Merrimack St. Lowell, MA 01852

Dear Madam Manager;

At the Board of Health Meeting held on October 3, 2018, the Board discussed the ongoing repairs of various school buildings in the City, and the increasing number of schools being cited for critical violations of the State Sanitary Code.

The Board is concerned about several reports from Senior Sanitary Code Inspector Shawn Machado regarding recent failed sanitary code inspections at several of the schools including rodent droppings, damaged drywall and ceiling tiles, trip hazards in a walk-in refrigerator, and water pouring in through various school roofs during the recent rains. These are considered “critical violations”, in that, if they occurred in a City restaurant or food establishment would be cause for closure due to Health Code violations until the necessary repairs or corrections were made.

The Board has requested updates from Public Works Commissioner Jim Donison at the last two Board Meetings. Commissioner Donison has neither provided those updates nor has he attended the meetings. Additionally, the Board extended an invitation to Mr. Rick Underwood, Director of Facilities for the School Department to attend the October 3rd meeting for the purpose of updating the Board, and received no response. It is also the understanding of the Board that the weekly meetings with the Public Works Department, Building Commissioner, Senior Sanitary Code Inspector, and the School Department regarding school repairs have slowed or ceased. These meetings were beneficial to prioritize repairs, and by doing so, the number of schools failing their bi-annual Sanitary Code inspections dropped significantly.

As a result of these violations, the Board Members made and approved a motion to request the Superintendent of Schools, Jeannine Durkin, or her representative, to attend the November 7, 2018 Board of Health meeting for the purpose of updating the Board regarding the on-going repairs in the schools. Of special concern are the leaking roof and tunnel at the High School, steps being taken with the new extermination company to combat the rodent infestation being reported at several schools as well as other critical violations noted in the current Sanitary Code inspections and previous Building Code violations noted in the report by former Building Commissioner Shaun Shanahan.

The Board would like to respectfully request, if possible, the attendance of a representative from your office as well as Commissioner Donison at the Board of Health meeting scheduled for 6:00 PM on November 7, 2018 in the Mayor’s Reception Room, City Hall, so all the parties are able to discuss the ongoing problems and possibly move forward with addressing the most serious problems as the health and welfare of our school children are of the utmost importance.

Sincerely,

Jo-Ann Keegan Chairwoman, Lowell Board of Health

Cc: James Donison, Commissioner of Public Works Jeannie Durkin, Acting Superintendent of Lowell Public School Shawn Machado, Senior Sanitary Code Inspector Eric Slagle, Director of Development Services David Fuller, Building Commissioner

10.11.18/kaa/BOH

Jeannine Durkin Acting Superintendent, Lowell Public Schools 155 Merrimack St, 4th floor Lowell, MA 01852

Dear Madam Superintendent;

At the Board of Health Meeting held on October 3, 2018, the Board discussed the ongoing repairs of various school buildings in the City, and the increasing number of schools being cited for critical violations of the State Sanitary Code.

The Board is concerned about several reports from Senior Sanitary Code Inspector Shawn Machado regarding recent failed sanitary code inspections at several of the schools including rodent droppings, damaged drywall and ceiling tiles, trip hazards in a walk-in refrigerator, and water pouring in through various school roofs during the recent rains. These are considered “critical violations”, in that, if they occurred in a City restaurant or food establishment they would be cause for closure due to Health Code violations until the necessary repairs or corrections were made.

The Board did extend an invitation to Mr. Rick Underwood, Director of Facilities for the School Department, to attend the October 3rd meeting for the purpose of updating the Board and received no response. It is also the understanding of the Board that the weekly meetings with the Public Works Department, Building Commissioner, Senior Sanitary Code Inspector, and the School Department regarding school repairs have slowed or ceased. These meetings were beneficial to prioritize repairs, and by doing so, the number of schools failing their bi-annual Sanitary Code inspections dropped significantly.

As a result of these violations, the Board Members made and approved a motion to respectfully request that you (or your representative) as well as Mr. Underwood, attend the Board of Health Meeting scheduled for 6:00 PM on November 7, 2018 in the Mayor’s Reception Room, City Hall, for the purpose of updating the Board regarding the on-going repairs in the schools. Of special concern are the leaking roof and tunnel at the High School, steps being taken with the new extermination company to combat the rodent infestation being reported at several schools as well as other critical violations noted in the current Sanitary Code inspections and Building Code violations noted in the report by former Building Commissioner Shaun Shanahan.

The Board has also requested that, if possible, a representative from City Manager Eileen Donoghue’s office, and DPW Commissioner Jim Donison also attend the November 7, 2018 Board meeting so all the parties are able to discuss the ongoing problems and possibly move forward with addressing the most serious problems as the health and welfare of our school children are of the utmost importance.

Sincerely,

Jo-Ann Keegan Chairwoman, Lowell Board of Health

Cc: Rick Underwood, Director of Facilities, LPS Eileen Donoghue, City Manager

10.4.18/kaa/BOH

2018 3rd Quarter Report to the Lowell, Massachusetts Board of Health

Reporting Period: July 1 2018- Sep 30 2018 • INTRODUCTION: This is the 3rd Q 2018 Report for the Lowell Board of Health.

Any questions or concerns surrounding the contents of this report should be directed to: Trinity EMS, Inc. ATTN: Kirk Brigham, Director of Clinical Services PO Box 187 Lowell, MA 01853 Email: [email protected]

Thank you,

Management Team Trinity EMS, Inc

2 TABLE OF CONTENTS

• I. Introduction Page 2 • II. Table of contents Page 3 • III. 911 Operational Performance Data Page 4 • IV. 911 Clinical Performance Data Page 7 • V. Graphics- Charts Page 9 • VI New Trinity employee list Page 16 • VII EMD- New for Q3 2018 Page 17 • VIII Quarterly opioid report Page 18-21 • IX Glossary of Terms Page 22-26

3 TIMES: Trinity BLS Q4 2017 Trinity ALS LGH ALS Trinity BLS Q1 2018 Trinity ALS LGH ALS Fractile % 92.48% 91.53% 79.73 92.54 Avg out of chute 28 sec 1 min 8 sec 1 min 7 sec 31 sec 1 min 4 sec 1 min 2 sec Avg resp time 5 min 26 sec 6 min 53 sec 6 min 4 sec 5 min 3 sec 7 min 6 sec 6 min 8 sec Avg on scene time 10 min 31 sec 8 min 45 sec 11 min 53 12 min 38 sec 15 min 18 sec 15 min 55 sec Avg transport time 6 min 21 sec 6 min 36 sec 10 min 24 sec 10 min 57 sec 11 min 4 sec 11 min 2 sec # of events >7:59 response time 419 35 130 476* 46 159 # of events using 3 happened in a 15 minute frame. 9,10, Non Trinity BLS 4 and 11th 911 call 0 *= including calls EMD'ed via TEMS Trinity BLS Q2 2018 Trinity ALS LGH ALS Trinity BLS Q3 2018 Trinity ALS LGH ALS 94.04% 86.19% 94.03% 94.72% 87.23% 93.79% Avg out of chute 32 seconds 58 seconds 54 seconds 23 seconds 55 seconds 48 seconds Avg resp time 4 min 50 sec 6 min 3 sec 5 min 10 sec 4 min 2 sec 5 min 43 sec 5 min Avg on scene time 12 min 34 sec 15 min 47 sec 15 min 55 sec 12 min 27 sec 15 min 10 sec 14 min 53 sec Avg transport time 7 min 8 sec 8 min 23 sec 12 min 30 sec 6 min 48 sec 8 min 3 sec 12 min 13 sec # of events >7:59 response time 335* 35 108 300* 28 146 # of events using Non Trinity BLS 0 0

Q3 2016 Q4 2016 Q1 2017 Q3 2017 Q4 2017 Q1 2018 Q2 2018 Q3 2018 TEMS BLS 94.66% 94.79% 95.38% 94.09% 92.48% 91.53% 94.04% 94.72%

4 BLS OUTLIERS: 2016 Total 2017 Total Last 4 Qs Total Q4 2017 Q1 2018 Q2 2018 Q3 2018 1st Emergency 204 19% 243 21% 369 24% 105 25% 113 24% 68 20% 83 28% 2nd Emergency 271 25% 210 18% 387 25% 103 25% 114 24% 91 27% 79 26% 3rd Emergency 207 19% 206 18% 282 19% 84 20% 87 18% 56 17% 55 18% 4th Emergency 167 15% 166 15% 207 14% 54 13% 72 15% 41 12% 40 13% 5th Emergency 155 14% 191 17% 141 9% 30 7% 50 11% 37 11% 24 8% 6th Plus Emergency 96 9% 124 11% 137 9% 36 9% 40 8% 42 13% 19 6%

BLS REASONS OVER 7:59: 2016 Yearly Total2017 Yearly Total Last 4 Qs Total Q4 2017 Q1 2018 Q2 2018 Q3 2018 Total 903 1189 1529 418 476 335 300 Couldn’t locate house/lost 96 11% 22 2% 52 3% 24 6% 10 2% 8 2% 10 3% Crew took long route 82 9% 60 5% 133 9% 38 9% 32 7% 20 6% 43 14% Distance 194 21% 555 47% 403 26% 115 28% 121 25% 84 25% 83 28% Dispatch delay 87 10% 56 5% 15 1% 0 0% 5 1% 10 3% 0 0% Highway 20 2% 32 3% 11 1% 3 1% 4 1% 2 1% 2 1% Out of chute 102 11% 188 16% 209 14% 66 16% 63 13% 44 13% 36 12% TEMS Dispatch error 17 2% 45 4% 109 7% 16 4% 26 5% 38 11% 29 10% Weather 84 9% 5 0% 51 3% 4 1% 41 9% 2 1% 4 1% EMD 212 14% 43 10% 77 16% 50 15% 42 14% 911 Call volume 126 14% 115 10% 245 16% 56 13% 85 18% 63 19% 41 14% others/blank 95 11% 111 9% 89 6% 53 13% 12 3% 14 4% 10 3%

5 NO TRANSPORTS: 2016 Total 2017 Total Last 4 Qs Total Q4 2017 Q1 2018 Q2 2018 Q3 2018 Cancelled via ALS 275 4% 308 4% 452 6% 114 6% 111 7% 113 6% 114 6% Cancelled via BLS 107 1% 114 2% 129 2% 40 2% 37 2% 26 1% 26 1% Cancelled closer unit 111 1% 150 2% 202 3% 28 1% 52 3% 71 4% 51 3% Cancelled by fam/staff 61 1% 56 1% 31 0% 6 0% 3 0% 21 1% 1 0% Cancelled via Fire 700 9% 579 8% 592 8% 150 8% 128 8% 165 9% 149 8% Cancelled via Police 1315 17% 1262 17% 1079 14% 267 14% 249 15% 232 12% 331 17% No EMS needed 1090 14% 650 9% 1039 14% 313 16% 295 17% 185 10% 246 12% No pt found 476 6% 482 6% 545 7% 107 6% 104 6% 185 10% 149 8% Pt deceased on arrival 167 2% 133 2% 171 2% 49 3% 45 3% 37 2% 40 2% Other 66 1% 146 2% 33 0% 1 0% 23 1% 6 0% 3 0% Pt refusal 3167 42% 3607 48% 3196 43% 830 44% 642 38% 861 45% 863 44%

6 VOLUME: 2016 2017 Last 4 Qs Q4 2017 Q1 2018 Q2 2018 Q3 2018 Total responses (ALS & BLS) 27317 29696 31131 7863 7741 7728 7799 Total ALS Responses 7417 27% 8196 28% 8312 27% 1964 25% 2121 27% 2108 27% 2119 27% TEMS ALS Responses 846 11% 871 11% 1007 12% 242 12% 252 12% 293 14% 220 10% LGH ALS Responses 6571 89% 7325 89% 7305 88% 1722 88% 1869 88% 1815 86% 1899 90%

INCIDENTS: 19900 21500 22492 5572 5620 5620 5680 BLS Incident 12483 13304 14211 3600 3494 3556 3561 ALS and BLS Incident 7417 8196 8281 1972 2126 2064 2119 Needle pick ups 724 95 134 221 274 Non Emergent Lift assists 298 45 46 101 106

TRANSPORTS: 2016 2017 Last 4 Qs Q4 2017 Q1 2018 Q2 2018 Q3 2018 Total Transports (ALS & BLS) 14303 14781 16126 4044 3790 4193 4099 Total BLS Transports 11498 80% 11735 79% 13005 81% 3288 81% 2965 78% 3324 79% 3428 84% Total ALS Transports 2805 20% 3046 21% 3121 19% 756 19% 825 22% 869 21% 671 16% TEMS ALS Transports 504 18% 434 14% 485 16% 117 15% 109 13% 161 19% 98 15% LGH ALS Transports 2301 82% 2612 86% 2636 84% 639 85% 716 87% 708 81% 573 85%

TRIAGE: 2016 2017 Last 4 Qs Q4 2017 Q1 2018 Q2 2018 Q3 2018 Total Triaged 993 13% 1102 13% 1044 13% 239 12% 260 12% 240 11% 305 14% TEMS Triage 74 9% 60 7% 79 8% 19 8% 27 11% 15 5% 18 8%

LGH ALS Triage 919 14% 1042 14% 965 13% 220 13% 233 12% 225 12% 287 15%

7 INTUBATIONS: 2016 2017 Last 4 Qs Total Q4 2017 Q1 2018 Q2 2018 Q3 2018 Trinity company total 56 of 68 82% 48 of 98 49% 79of 91 87% 35of 39 90% 19of 25 76% 15of 16 94% 10of 11 91% Trinity Lowell only 7 of 14 50% 2 of 729% 12of 16 75% 5 of 5 100% 2 of 6 33% 4 of 4 100% 1 of 1 100% LGH ALS Lowell only 140 of 144 97% 166 of 174 95% 160 of 167 96% 48of 48 100% 35of 39 90% 39of 39 100% 38of 41 93% LGH Greater Lowell region 69of 73 95% 73of 74 99% 58of 61 95% LGH ALS MAI* in Lowell only 44 55 45 17 14 14 16 (24 system wide) IO SUCCESS RATE: 2016 2017 Last 4 Qs Total Q4 2017 Q1 2018 Q2 2018 Q3 2018

Trinity company total 77 of 79 97% 65 of 69 94% 103 of 104 99% 34of 35 97% 29of 29 100% 27of 27 100% 13of 13 100% Trinity Lowell only 10 of 10 100% 6 of 6 100% 19 of 19 100% 4 of 4 100% 8 of 8 100% 6 of 6 100% 1 of 1 100% LGH ALS Lowell only 45 of 47 96% 72 of 75 96% 86of 86 100% 28of 28 100% 19of 19 100% 18of 18 100% 21of 21 100%

Airways: 2016 2017 Last 4 Qs Total Q4 2017 Q1 2018 Q2 2018 Q3 2018

Trinity company wide- King 1 1 1 1 tube success rate-post ETT 0 0 0 0 0 0 0 0 failure ### #### ### 4 of 4 % 6 of 6 % 1 of 1 % 1 of 1 %

Trinity Lowell- King tube n n n success rate-post ETT failure ### #### ### 0 of 0 4 of 4 a 0 of 0 a 0 of 0 a * Intubation total- Total patients intubated/ Total Patients intubated attempted. ** Medication Assisted Intubation, in MA, this requires the use of a Paralytic which is controlled & monitored by a special project

8 3rd Qrt 2018

16 15 14 13 12 11 10 9 8 7 6 5 4 3 2 1 0 Avg out of chute Avg resp time Avg on scene time Avg transport time

TEMS BLS TEMS ALS LGH ALS

BLS Fracile Response % (under 8:00) 100.00% 95.38% 94.66% 94.79% 94.09% 94.04% 94.72% 95.00% 92.48% 91.53%

90.00%

85.00%

80.00% Q3 2016 Q4 2016 Q1 2017 Q3 2017 Q4 2017 Q1 2018 Q2 2018 Q3 2018

TEMS BLS Contract

9 Q3 2018 BLS OUTLIERS: Yearly view 450 387 400 369 350 300 271 282 243 250 210 207 206 207 204 191 200 167 166 155 141 137 150 124 96 100 50 0 1st Emergency 2nd Emergency 3rd Emergency 4th Emergency 5th Emergency 6th Plus Emergency

2016 Yearly Total 2017 Yearly Total Last 4 Qs Total

Q3 2018 BLS OUTLIERS: Qrts View

120 113 114 105 103

100 91 87 83 84 79 80 72 68

60 56 55 54 50 41 40 40 42 37 40 36 30 24 19 20

0 1st Emergency 2nd Emergency 3rd Emergency 4th Emergency 5th Emergency 6th Plus Emergency

Q4 2017 Q1 2018 Q2 2018 Q3 2018 Q3 2018 BLS REASONS OVER 7:59: Yearly view 600 550 555 500 450 403 400 350 300 245 209 250 194 188 200 133 150 109 126 115 111 96 82 87 102 84 95 89 100 60 56 52 32 45 51 50 22 15 20 11 17 5 0 Couldn’t locate Crew took long Distance Dispatch delay Highway Out of chute TEMS Dispatch Weather 911 Call volume others/blank house/lost route error

2016 Yearly Total 2017 Yearly Total Last 4 Qs Total

Q3 2018 BLS REASONS OVER 7:59: Qrts View

140 121 120 115

100 84 83 85 80 66 63 63 56 60 53 43 44 41 42 41 38 36 38 40 32 29 24 26 20 16 20 12 14 10 8 10 10 10 5 4 4 4 0 0 3 2 2 2 0 Couldn’t locate Crew took long Distance Dispatch delay Highway Out of chute TEMS Dispatch Weather EMD 911 Call others/blank house/lost route error volume Q4 2017 Q1 2018 Q2 2018 Q3 2018 11 BLS No Transports: Years View Pt refusal- Year

1400 1315 3700 1262 3607 1200 1079 3600 1090 1039 1000 3500

800 3400 700 650 579 592 545 600 3300 452 476 482 3196 400 275 308 171 3200 3167 107 129 202 167 200 114 111 150 133 146 3100 61 56 31 66 33 0 3000 Cancelled via Cancelled via Cancelled Cancelled by Cancelled via Cancelled via No EMS No pt found Pt deceased Other ALS BLS closer unit fam/staff Fire Police needed on arrival 2900 2016 2017 Last 4 Qs 2016 Total 2017 Total Last 4 Qs Total Total Total Total

BLS No Transports: Qrts View Pt refusal-Qrts 350 331 1000 313 295 900 861 863 300 830 267 249 246 800 250 232 185 700 642 200 185 165 600 150 128 149 150 114 149 500 111113 114 107104 400 100 71 52 51 37 40 37 26 49 45 40 300 50 26 28 21 23 6 3 1 1 6 3 200 0 100 Cancelled via Cancelled via Cancelled Cancelled by Cancelled via Cancelled via No EMS No pt found Pt deceased Other ALS BLS closer unit fam/staff Fire Police needed on arrival 0 Q4 Q1 Q2 Q3 Q4 2017 Q1 2018 Q2 2018 Q3 2018 2017 2018 2018 2018 12 Q3 2018 ALS Response %: Yearly View Q3 2018 ALS Response %: Qrts View 100% 100% 90% 89% 89% 88% 88% 88% 86% 90% 90% 80% 80% 70% 70% 60% 60% 50% 50% 40% 40% 30% 30% 20% 20% 14% 11% 11% 12% 12% 12% 10% 10% 10% 0% 0% 2016 2017 Last 4 Qs Q4 2017 Q1 2018 Q2 2018 Q3 2018

TEMS ALS Responses LGH ALS Responses TEMS ALS Responses LGH ALS Responses

Q3 2018 ALS Transports %: Yearly View Q3 2018 ALS Transports %: Qrts View 100% 100% 86% 84% 85% 87% 85% 90% 82% 90% 81% 80% 80% 70% 70% 60% 60% 50% 50% 40% 40% 30% 30% 18% 16% 19% 20% 14% 20% 15% 13% 15% 10% 10% 0% 0% 2016 2017 Last 4 Qs Q4 2017 Q1 2018 Q2 2018 Q3 2018

TEMS ALS Transports LGH ALS Transports TEMS ALS Transports LGH ALS Transports 13 Q3 2018 Triaged: Yearly View Q3 2018 Triaged: Yearly View % 16% 1200 1102 1042 1044 14% 14% 993 965 14% 13% 1000 919 12% 800 10% 9% 8% 600 8% 7%

400 6% 4% 200 74 79 60 2% 0 0% 2016 2017 Last 4 Qs 2016 2017 Last 4 Qs

Total Triages TEMS ALS Triage LGH ALS Triage TEMS ALS Triage LGH ALS Triage

Q3 2018 Triaged: Qrts View Q3 2018 Triaged: Qrts View % 15% 350 16% 305 287 14% 300 13% 12% 12% 260 239 233 240 12% 11% 250 220 225 10% 200 8% 8% 8% 150 6% 5% 100 4% 27 50 19 15 18 2% 0 Q4 2017 Q1 2018 Q2 2018 Q3 2018 0% Q4 2017 Q1 2018 Q2 2018 Q3 2018 Total Triages TEMS ALS Triage LGH ALS Triage TEMS ALS Triage LGH ALS Triage 14 Overall Intubation rate: Qrts View 100%100% 100% 100%100% 100% 100% 100% 94% 90% 90% 91% 90% 80% 76% 70% 60% 50% 40% 30% 20% 10% 0% Q4 2017 Q1 2018 Q2 2018 Q3 2018

Trinity company total Trinity Lowell only LGH ALS Lowell only

IO success rate: Qrts View 97% 100%100%100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Q4 2017 Q1 2018 Q2 2018 Q3 2018

Trinity company total Trinity Lowell only LGH ALS Lowell only

15 Last Name First Name Title Hire Date Position MA CertificationMA Certification # CPR Exp Exp National RegistryNational Certification Registry Exp. Gonzalez Jeanmerli (PT) EMT-B 2018-09-17 EMT-B E0913718 2021-04-01 2020-02-28 E3398810 2020-03-31 Kiernan Michael (PT) EMT-B 2018-09-17 EMT-B E0912829 2020-04-01 2020-02-28 E3394948 2020-03-31 Kreamer Mark (PT) EMT-B 2018-09-17 EMT-B E900872 2020-04-01 2019-08-31 E3013665 2020-03-31 Moura Steven (FT) EMT-B 2018-09-17 EMT-B E0903595 2020-04-01 2020-03-31 E3104990 2020-03-31 Chorlian Alexandra (PT) EMT-B 2018-08-20 EMT-B E0912844 2020-04-01 2018-11-30 E3391676 2020-03-31 LaFlamme Erik (FT) EMT-B 2018-08-20 EMT-B E0913000 2021-04-01 2019-05-31 E3397675 2020-03-31 Martel Grace (PT) EMT-B 2018-08-20 EMT-B E0910271 2019-04-01 2019-07-31 E3264667 2019-03-31 Mayer Katherine (PT) EMT-B 2018-08-20 EMT-B E0911766 2020-04-01 2019-09-30 E3365276 2020-03-31 Mumper William (FT) EMT-B 2018-08-20 EMT-B E0913230 2021-04-01 2020-06-30 E3405421 2021-03-31 Regan Jordan (PT) EMT-B 2018-08-20 EMT-B E0911551 2020-04-01 2020-07-31 E3342686 2020-03-31 Schafer Louise (FT) EMT-B 2018-08-20 EMT-B E0907699 2020-04-01 2020-07-13 E3262403 2020-03-31 Shiba Steven (PT) EMT-B 2018-08-20 EMT-B E0912559 2020-04-01 2020-03-31 E314461 2019-03-31 DiGenova Meagan (FT) EMT-B 2018-07-16 EMT-B E0912968 2020-04-01 2020-02-28 E3394950 2020-03-31 Frias Gabriel (FT) EMT-P 2018-07-16 EMT-P P0902954 2020-04-01 2019-07-31 M5059039 2020-03-31 Glabicky John (PT) EMT-P 2018-07-16 EMT-P P875387 2019-04-01 2019-10-31 Libby Kaitlyn (PT) EMT-B 2018-07-16 EMT-B E0912719 2020-04-01 2020-02-28 E3390128 2020-03-31 Lora Michael (PT) EMT-B 2018-07-16 EMT-B E0907835 2019-04-01 2020-04-30 E3251060 2020-03-31 McHugh Alec (FT) EMT-B 2018-07-16 EMT-B E0912961 2020-04-01 2020-02-28 E3398386 2020-03-31 O'Connor Colette (FT) EMT-B 2018-07-16 EMT-B E0912895 2020-04-01 2020-04-30 E3387206 2020-03-31 Reilly Bryan (FT) EMT-B 2018-07-16 EMT-B E0912725 2020-04-01 2020-02-28 E3391677 2020-03-31

16 EMD- Direct to Trinity

2016 Total 2017 Total Last 4 Qs Total Q4 2017 Q1 2018 Q2 2018 Q3 2018 Alpha (BLS-P3) 1285 1405 1473 358 393 370 352 Bravo (BLS-P2) 385 410 459 112 132 121 94 Charlie (ALS-P1) 660 679 703 156 199 186 162 Delta (ALS-P1) 522 645 647 160 184 146 157 Echo (ALS-P1) 2 2 2 0 1 1 0 Total EMD by Trinity 2854 3141 3284 786 909 824 765

The above data are direct calls to Trinity for patients in Lowell. Alpha- results in BLS going no lights or sirens to the patient Bravo- results in BLS going lights and sirens to the patient Charlie, Delta, Echo- results in ALS and BLS going lights and sirens to the patient As part of Trinity EMS’s EMD accreditation a portion of the above calls are randomly selected for quality assurance review. TEMS reviews 25 EMD’ed calls per week. These 25 calls could come from any city or state. Potentially none or all 25 calls could be for patients in Lowell.

17 2016 Total 2017 Total Last 4 Qs Total Q4 2017 Q1 2018 Q2 2018 Q3 2018 Total ORI in Lowell 676 802 773 165 189 183 236 Priority 1 ORI in Lowell 371 468 420 90 109 102 119 Trinity wide ORI 1111 1255 1163 261 296 286 320 Trinity wide Priority 1 674 752 664 148 169 172 175 ORI in Lowell by setting: Inside Private home 325 48% 348 43% 319 41% 71 43% 87 46% 87 48% 74 31% Public location inside 77 11% 55 7% 61 8% 11 7% 29 15% 11 6% 10 4% Public location outside 249 37% 370 46% 374 48% 77 47% 68 36% 83 45% 146 62% Other 25 4% 29 4% 19 2% 6 4% 5 3% 2 1% 6 3% Gender: Female 193 29% 234 30% 211 27% 48 29% 45 24% 51 28% 67 28% Male 483 71% 558 70% 562 73% 117 71% 144 76% 132 72% 169 72% Females U20 3 2% 6 3% 1 0% 0 0% 1 2% 0 0% 0 0% Female 20-29 55 28% 70 30% 75 36% 12 25% 19 42% 21 41% 23 34% Female 30-39 66 34% 101 43% 82 39% 25 52% 16 36% 17 33% 24 36% Female 40 - 49 48 25% 37 16% 34 16% 10 21% 6 13% 7 14% 11 16% Female 50- + 21 11% 20 9% 19 9% 1 2% 3 7% 6 12% 9 13% Male U20 5 1% 2 0% 1 0% 0 0% 0 0% 0 0% 1 0% Male 20-29 120 25% 163 29% 184 33% 42 33% 44 36% 44 31% 54 33% Male 30- 39 151 31% 194 35% 168 30% 39 30% 46 33% 40 32% 43 30% Male 40 - + 112 23% 115 21% 122 22% 27 22% 24 23% 33 17% 38 25% Male 50 - + 95 20% 84 15% 87 15% 9 15% 30 8% 15 21% 33 11%

18 Acre 127 19% 106 13% 104 13% 13 8% 29 15% 33 18% 29 12% Back Central 72 11% 90 11% 108 14% 20 12% 11 6% 19 10% 58 25% Belvidere 26 4% 21 3% 15 2% 4 2% 7 4% 3 2% 1 0% Centralville 96 14% 131 16% 103 13% 22 13% 27 14% 28 15% 26 11% Downtown 161 24% 182 23% 192 25% 45 27% 54 29% 41 22% 52 22% Highlands 41 6% 53 7% 52 7% 17 10% 14 7% 7 4% 14 6% Lower Belvidere 16 2% 14 2% 18 2% 1 1% 4 2% 3 2% 10 4% Lower Highlands 64 9% 97 12% 77 10% 21 13% 18 10% 16 9% 22 9% Pawtucketville 34 5% 40 5% 48 6% 9 5% 9 5% 17 9% 13 6% Sacred Heart 28 4% 50 6% 42 5% 8 5% 13 7% 13 7% 8 3% South Lowell 11 2% 18 2% 14 2% 5 3% 3 2% 3 2% 3 1%

Home towns of patients: Lowell 361 62% 450 66% 471 61% 93 56% 123 65% 120 66% 135 57% Dracut 29 5% 22 3% 28 4% 7 4% 5 3% 6 3% 10 4% Billerica 26 4% 16 2% 20 3% 4 2% 4 2% 4 2% 8 3% Chelmsford 14 2% 20 3% 17 2% 1 1% 4 2% 3 2% 9 4% Tewskbury 11 2% 14 2% 16 2% 3 2% 5 3% 2 1% 6 3% Other/unknow 138 24% 165 24% 221 29% 57 35% 48 25% 48 26% 68 29%

19 ORI Lowell- Yearly Total ORI- Qrts View

900 300 802 773 800 250 676 250 700 211 600 200 176 497 165 500 147 382 150 122 400 109 284 90 300 100 200 50 100 0 0 2016 Total 2017 Total Last 4 Qs Total Q4 2017 Q1 2018 Q2 2018 Q3 2018

Total ORI Priority 1 Total ORI in Lowell Priority 1 ORI in Lowell

Setting of ORI - % Yearly View Setting of ORI - % Qrts View 60% 70% 62% 48% 48% 50% 60% 41% 47% 46% 48% 40% 37% 50% 43% 45% 40% 36% 30% 31% 30% 20% 11% 8% 20% 10% 4% 2% 10% 0% Inside Private home Public location inside Public location Other 0% outside Q4 2017 Q1 2018 Q2 2018 Q3 2018

2016 Total 2017 Total Last 4 Qs Total Inside Private home Public location inside Public location outside Other

20 Yearly View - % by section of the city 30% 25% 25% 24%

20% 19%

14% 15% 13% 14% 13% 11% 9% 10% 10% 6% 7% 6% 5% 5% 4% 5% 4% 2% 2% 2% 2% 2% 0% Acre Back Central Belvidere Centralville Downtown Highlands Lower Belvidere Lower Highlands Pawtucketville Sacred Heart South Lowell

2016 Total % 2017 Total % Last 4 Total %

Qrts View - % by section of the city

30% 27% 25% 25% 22%

20%

15% 13% 12% 12% 13% 11% 10% 9% 10% 8% 6% 5% 6% 5% 4% 3% 5% 2% 3% 0% 1% 1% 0% Acre Back Central Belvidere Centralville Downtown Highlands Lower Belvidere Lower Highlands Pawtucketville Sacred Heart South Lowell Q4 2017 Q1 2018 Q2 2018 Q3 2018 21 Life Support- may refer to vehicles staffed with a least one or refer to a paramedic level of patient care. Trinity Emergency ALS vehicles are ALS: staffed with two .

Is defined as dispatching or sending an to a request for service. In this report , a response is further sorted to include only emergency A Response: responses. These numbers do not include routine transfers such as dialysis patients or radiation treatment patients. A Transport: Is defined as taking a patient in an ambulance to a destination.

Basic Life Support- may refer to a vehicle staffed with two emergency medical technicians (EMT) or an EMT level of patient care. Trinity BLS BLS: are staffed with two EMT's

Emergency Medical Dispatch- a nationally recognized system whereby dispatchers are trained and follow a specific protocol to ascertain the nature of EMD: illness/injury and provide patient care instructions to the caller until the First Responders or ambulance arrives. Intubation Attempt: Is defined as insertion of the laryngoscope blade into the oral cavity for the purpose of inserting an endotracheal tube.

Medication Assisted Intubation is generally regarded as facilitating an intubation with the use of sedatives. In Massachusetts how ever, this term includes the use of Paralytics. The Massachusetts MAI program is not part of the standard scope of practice for Paramedics. It is controlled through the MAI: Department of Public Health's Office of Emergency Medical Services Medical Services Committee.

The amount of time that has elapsed from the moment the ambulance is on scene to the moment the ambulance begins transport or is released back On scene time: into service

Out of chute time: The amount of time that elapses from the moment when the ambulance is dispatched to the moment the ambulance begins moving towards the call. On time performance score: Is the percentage of calls that meet or exceed the response time criteria. Request for service: When a dispatcher receives request for an ambulance usually via telephone or radio

The amount of time that has elapsed from the moment the call is completely entered into the dispatch system to the moment the am bulance arrives on Response time: scene. 22 RSI: Rapid Sequence Intubation is the facilitation of intubation using both sedatives and paralytics

M.G.L. Part 1 Title XVL Chpt. 11C Section 1 defines as "a geographic area defined by and comprised of one or more local jurisdictions, in which a local jurisdiction may select and the department shall designate an EMS first response service and an ambulance service to provide EMD first response and Service Zone Plan: primary ambulance response to the public within the defined area, pursuant to section 10." Massachusetts Regulations 105 CMR 170.249.

The amount of time that has elapsed from the moment the ambulances leaves the scene with a patient to the moment the ambulance arrives at the Transport time: receiving facility

When a paramedic units arrives at the patients side and based on the patient condition determines that the patient may be treated and transported at Triage down: the BS level. Note- There is no protocol for this practice, however, OEMS does address it though an administrative advisory: A/R5=620.

23 • The following document is a detailed outline of the reporting process used by Trinity EMS. • Responding lights and sirens • From Lowell 911 • All calls require a lights and sirens response regardless of the patients condition except • Needle pick ups • Pt carry down/up without a medical issue • Unless requested to response without lights and sirens by the 911 center. • Direct to Trinity calls that Trinity EMD’s • Bravo, Charlie, Delta, and Echo go with lights and sirens • Alpha or Omega level calls go without lights and sirens • Direct to Trinity that Trinity doesn’t EMD • Response lights and sirens for any patients. Unless the calling agency EMD’ed the call to a non-urgent level. • This set of calls would include call from UMASS PD, or other ambulance services. • Incident • A request for or by someone within the city limits of Lowell that requires an EMS response. • Each request is counted as 1 incident • A patient that gets a BLS unit for back pain is counted as 1 incident • A 10 car MVC with 20 patients requiring 6 BLS, 2 ALS, and 2 helicopters is counted as 1 incident • Responses • Counts the number of occurrences when EMS vehicles response lights and sirens to a call. • An ALS and BLS unit response to a patient with chest pain, that counts as 2 responses. (2 vehicles put their lights on) • Times: • All below are from incidents • BLS • Priority 1, and 2 incident responses • Includes 911 and calls direct to Trinity • ` Any call directly to Trinity from another call center that would require an emergent response • (IE- Umass Lowell calls Trinity for a chest pain) • Any Charlie, Delta, Echo response called and EMD’ed by Trinity • Includes call when ALS and BLS responded as well as call when just BLS responded. • Q# year# Performance score • Is the created by • Dividing the number of incidents BLS units responded to.

24 • Into the number of those calls that shows a response time over 08:00 or greater • Calls excluded • Delta level calls EMD’ed by Trinity that had a total response time of greater than 07:59 • Avg out of chute • Time from Trinity designated and selected ambulance was assigned call to selected crew to the time selected vehicles starts movement towards this call • Excluded- • Any time showing more than 10 minutes is excluded as likely time stamp missing • Avg response time • From Call saved by Trinity dispatch to time ambulance arrived at geocoded location of the call. • Within Trinity CAD- The call saved time is called “call taken”. This time is created after Trinity dispatch get an address, apartment, complaint, and any other info 911 passed along. • Excluded- • Charlie, delta, Echo, and Omega calls direct and EMD’ed by Trinity that result in a response time over 07:59 • Any time showing more than 20 minutes is excludes as likely time stamp missing • Avg on scene time • Includes only calls included above • Time from crew arrival on site to time vehicle: • Clears • Occupies to the hospital • Excluded • Any time showing more than 30 minutes is excludes as likely time stamp missing • Avg transport time • Includes only calls included above • Time from crew: Clears or arrives to the hospital • Excluded • Any time showing more than 20 minutes is excludes as likely time stamp missing • # of events >7:59 or greater • Includes any call that includes calls included from reasons earlier in the section • That’s response time is greater than 07:59 • Excluded • Any call where the unit is canceled prior to arrival • Called that were EMD’ed by Trinity

25 o No other calls are excluded- weather, 911 call volume as examples are outliers counted and categories in the “BLS reasons over 07:59”  # of events using Non Trinity BLS units • Requests for ambulances to Trinity that Trinity was not able to send a BLS unit on within the State mandated 5 minute dispatch time for o Any 911 priority 1 or 2 call o Any call directly to Trinity from another call center that would require an emergent response  (IE- UMass Lowell calls Trinity for a chest pain) o Any Charlie, Delta, Echo response called and EMD’ed by Trinity o ALS  The only difference from the BLS is the ALS times start at dispatch, and not call created • BLS Outliers: o For any BLS response over 07:59  Trinity will make note and report in this section the number of concurrent emergencies in Lowell at the time this call is created. • Includes 911 calls and calls direct to Trinity • Non-emergency and call in other cities will not be counted • BLS Reasons over 07:59 o For any BLS response over 07:59  Trinity will conduct a route cause analyses as to the reason for the response time  Trinity will take note and report in this section. These reasons will be grouping into 1 of the following • Couldn’t location house/lost • Crew passes the geo-coded location for the address more than once without getting on arrival  Crew took long route • Crew did not take the fastest route from their dispatch location to the pickup location  Distance • Usually this is used when a o Dispatcher gives the call out within 60 seconds o The crew is enroute within 120 seconds o Posting is happening o The ambulance crew went the most direct route o Circumstances include  If there is a second call in a sector of the city before reposting. 2 nd call in downtown, this ambulance to the second call has two reports a much greater distance to the patient.

26  Also the extra time could be traffic, school buses, and people not willing to move. I I  Gets used if none of the others fit. o ALSO  If the address is far away from one of the top 4 posting locations • Posting location 1 is Chelmsford and Westford • Posting location 2 is Bridge & W 6th • Posting location 3 is Callery Park • Posting location 4 is Mammoth and 4 th o Far away is not defined in miles. More looking at the map and lacking a different issue this is selected.  Dispatch chute • A Trinity EMS dispatch took more than 59 seconds from call saved to dispatch. This could be due to error or workload  Highway • The location of the call is a highway. Accessing highway locations usually takes extra time do to divided 1 way road  Out of Chute • The Trinity EMS crew took at least 120 seconds to get from a dispatched stage to the ambulance physically moving towards the call  GPS fail • If our ambulance tracking program is not running we cannot prove a response time or a root cause.  TEMS Dispatch error • An example of this is TEMS dispatcher entering the wrong house or address.  Weather • Did weather impact posting or travel time. Usually snow/ extreme cold or heat  911 Call volume  Was this call more than the 4 th emergency in Lowell at this time

27 rce JAMA I Originat tnvestigation rlled 37- Effect of a strategy of Initiaf Laryngeal Tube Insertion vs Endotracheal Intubation on72-Hour Survivaf in Adults With Out-of-Hospital Cardiac Arrest A Randomized Clinical Triaf

Henry E Wang' MD' MS: Robert H schmicker, MS; Mohamud R. Daya. MD. M5; shannon w. stephens, EMT-p; Jestin N. Carlson, MD, MS; M. Riccardo Ahamed H. ldris. MD; Colella, DO, MpH; Heather Henen, MpH, RN; Matthew Hansen, MD, MCR; Juan Carlos J. iuyana, BA; Tom p Aufderheide, NealJ. Richmond, MD; ,frD, |\f S, nrnJ.l E. Gray, MEd, NREMT-p; pameta C. CraV. NREMT_p; Mike Verkest, MS, EMT-p; tr..i, tr'r*, BSN, NRp; susan;"1 phD; ;'fr1'rtfJ,",ffififft#ff1,11;3i',jill,illr ;.y. Georse R Sopko, MD, MpH;

IMPoRTANcE Emergencymedicalservices(EMS)commonlyperformendotrachealintubation(ETl) !l VisualAbstract or insertion of supraglottic airways, such as the Editorial page 7G1 laryngealtube (LT), on patients with out_of_hospital l! cardiac arrest (oHCA). The optimar method for oHcA advanced ai*.y ,.n.g.rent is unknown. G Related article page 77 9 oBJEcrlvE To compare the effectiveness El Supplemental content of a strategy of initial LT insertion vs initial adults with ETI in OHCA. lI CMEQuizat jamanetwork.com/learning DESIGN' SETTING' AND PARTtcIPANTs and CME Questions page 934 Multicenter pragmatic cluster-crossover clinicaltrial involving EMS agencies from the Resuscitation outcomes consortium. The trial included adults 3o04 with OHCA and anticipated need for advanced ainray management who were enroiled from December1,2ol5, to November4,2017. The finardate of folow-up was Novemoerro,2017.

INTERVENTIoNS Twenty-seven EMS agencies were randomized in 13 clusters to initial airway management strategy with LT (n = l5O5 patients) or ETI (n = 1499 patients), with to the crossover alternate strategy at 3_ to 5_month intervals.

MA'N OUTCOMES AND MEASURTs The primary outcome was 72-hour survivar. Secondary outcomes incruded return ofspontaneous circuration. survivar to hospitar discharge, favorable neurorogicar status at hospitar discharge (Modified Rankin scare scor" and aoverse events. =:), key

REsULrs Among 3OO4 enrolled patients (median [interquartile range] age, 64 years, 1829 [53_76] [60.9%] men), 3ooo were incruded in the primary anarysis. Rates of initial airway success were 90'3% with LT and 516% with ETr. seventy-two hour survivar was 1g.3% in the LTgroup vs 154% in the ETI group (adjusted difference,2 .9o/o195%oCl,0.2%_5.6%l; p =.O+1. S"conaary outcomes in the LTgroup vs_ETIgroup were return of spontaneous circulation (27. go/ovs24.3%o; adjusted difference,3.6%olg'%Ct,O.3%_6.8%li p =.03); hospitalsurvival (lO.g% vs 8.1%; adjusted difference,2.To/o[95o/oCr,o.6%-4.g%]; p =.or); and favorabre neurorogicarstatus at discharge (7.1% vs 5.0%; adjusted difference, 2 .1%F,5% Ct, O.3%-3.8o/olt p There significant =.02). were no differences in oropharyngeal or hypopharyngeal injury (0.2% vs O 3%), airway (l.l% swelling vs l.O%), or pneumonia or pneumo nttiseA:Wvs22.3%).

coNcLUSrONS AND RELEVANCE Among adurts with oHcA, a strategy of initiar LT insertion associated was with significantly greater 72-hour survival compared with a strategy of initial ETr. These findings suggest that LT insertion Author Affiliationsr may be considered as an initial airway management Author strategy in patients affiliatlons are listed with oHCA, but rimitations of the pragmatic at the end of this design, practice setting, and article. ETI performance characteristics suggest that further research is warranted. Corresponding Author: Henry E. Wang, MD. MS. Department of TRTAL REGtSTRATtOtT ClinicalTrials.gov ldentifier: NCTo24lg573 . The University ofTexas Health Science Center at Houston, 6431 Fannin St, JJL 434, JA M A. 2O1 8 :320(8) :7 69 -77 8. doi :1O.tOOl/jama.2018.7044 Houston, TX 7703o (henry.e.wang @uth.tmc.edu).

fnm* Au6u:r e6 tW,vb\. i|^,.Jurrbe, k tr Intubation Survival in Out-of'Hospital Cardiac Arrest Research Originallnvestigation Initial Laryngeal Tube Insertion vs Endotracheal

ut-of-hospital cardiopulmonary arrest (OHCA) af- fects more than 350 OOO adults in the United States Key Points 10% surviving to hospital dis- each year, with less than Question What is the effect of an initial airway management charge in 2Ol6.t In the United States and countries with ad- strategy using laryngeal tube insertion' compared with vanced emergency medical services (EMS) systems, paramed- endotracheal intubation, on survival among adults ics commonly perform endotracheal intubation (ETI) on with out-of-hospital cardiac arrest? provide a conduit to the adults patients with cardiac arrest to direct Findings In this cluster-crossover randomized trial of 3004 Iungs, facilitate controlled oxygenation, and protect the lungs with out-of-hospital cardiac arrest, 72-hour survival was'18 3% for from aspiration of vomitus, laryngeal tube insertion and i5.4% for endotracheal intubation' ETI plays a central but controversial role in contempo- a significant difference. a stan- rary EMS care, More than 30 years ago, ETI became Meaning A strategy of initial laryngeal tube insertion' compared dard US paramedic practice under the assumption that it with endotracheal intubation, was associated with greater design would improve OHCA outcomes. However, numerous stud- likelihood of 72'hour survival, but given limitations in study ies have highlighted the challenges of paramedic ETI' and findings, additional research is warranted' including significant rates of unrecognized tube misplace- ment or dislodgement, need for multiple ETI attempts, existing research infra- and ETI insertion failure.2-a ETI has also been associated pragmatic trial principles, the use of to existing clin- with iatrogenic hyperventilation and chest compression structure, adherence as much as possible rather than interruptions.s'6 Furthermore, opportunities for EMS ETI ical practice, and focus on describing outcomes training and skills maintenance are limited in the United explanatory mechanisms' The Pragmatic-Explanatory 2 (PRECIS-2)17 wheel for States, with many paramedics performing only l live proce- Continuum Indicator Summary I in Supplement 2' The dure annually.T the trial is provided in eAppendix potential number Alternatives to ETI include supraglottic airway (SGA) capped funding amount constrained the devices including the laryngeal mask airway, esophageal- of enrolled patients. tracheal combitube, i-gel, and laryngeal tube (LT). Compared with ETI, SGA insertion is rapid, simple, and requires less Data and Safety Monitoring committee monitored training, while offering ventilatory characteristics that are A trial-appointed study monitoring protocol compliance and similar to ETI.8 While traditionally reserved for contingency EMS agency and regional center data and safety moni- use in the event of unsuccessful ETI efforts, SGA insertion data reporting. An NHlBl-appointed protocol, monitored the safety has been incorporated by many EMS agencies as the primary toring board approved the made recommendations method of ventilation during OHCA resuscitation. However, and interim results of the trial, and multiple observational studies reported better outcomes for its continuation or suspension. associated with ETI compared with SGAs.e-ll To date, few randomized clinical trials have compared Study Setting and Organization agencies associated with US sites ETI with other airway techniques in OHCA.12-14 This Resus- The trial included 27 EMS Consortium, a North Ameri- citation Outcomes Consortium Pragmatic Airway Resuscita- of the Resuscitation Outcomes to conduct tion Trial (PART) compared the effectiveness of initial LT can multicenter network funded by the NHLBI OHCA and major trauma and initial ETI strategies on outcomes in adult OHCA. clinical trials of therapies for (eTable I in Supplement 2). The University of Alabama at Birmingham and the University of Washington Clinical Trials Center functioned as the respective clinical and data Methods coordinating centers for the trial. Design We conducted a multicenter cluster-crossover randomized Selection of Patients (age years or per local interpre- trial. The trial methods have been previously reported, The trial included adults >18 OHCA treated by participating and the trial protocol is available in Supplement 1.1s The insti- tation) with nontraumatic support tutional review boards of the participating institutions EMS agencies and requiring anticipated ventilatory (eAppendix 2 in Supplement approved the trial under federal rules for conduct of emer- or advanced airway management care by EMS agen- gency research.under Exception From Informed Consent 2). Patients who received initial clinical and that were not (21 CFR 50.24). Participating sites satisfied all requirements cies with ETI or SGA insertion capabilities for this, including community consultation, public disclo- affiliated with the trial were excluded. sure, and notification of patient, family members, or legally authorized representatives'of effollment. lnterventions The trial randomized EMS agencies to either of 2 initial strategies: initial LT inser- Funding advanced airway management (eFigure 1 Supplement 2)' The trial was funded by a National Heart, Lung, and Blood tion or initial orotracheal ETI in only LT Institute (NHLBD program supporting large-scale, low-cost Although a variety of SGA devices are available, commonly pragmatic clinical trials.r6 This required following stipulated insertion was allowed because it is the most

JAMA August28,20l8 Volume32O.Number8 Jama.com : Arrest a Initial Laryngeal Tube Insertion vs Endotracheal Intubation Survival in Out-of-HosDital Cardiac Arrest Originallnvestigation Research

I

I used SGA in the United States. The protocol allowed the use anced enrollment between study groups. Enrollment in I of neuromuscular blocking agents or video laryngoscopy cluster projections; this cluster to I exceeded we instructed but not other techniques (eg, nasotracheal intubation) for carry out I additional crossover. One agency ended partici- initial intubation efforts. I pation in the trial prior to study completion; to compensate, The protocol did not prescribe or limit I the number of we instructed another cluster to defer its final crossover. I initial LT or ETI insertion attempts. If the initial LT/ETI These I decisions regarding changes to cluster crossover tim- I insertion efforts were unsuccessful, EMS personnel per- ings were made without knowledge of outcome data by ran- Its i formed rescue )r airway management using any available air- domization cluster. way technique, including bag-valve-mask (BVM) ventila- tion, ETI (i4cluding alternate ETI techniques such as nasal Odtcomes or digital intubation), insertion of LT or another SGA device, The primary outcome was survival to 72 hours after or needle jet ventilation or cricothyroidotomy. EMS person- the index arrest, determined from hospital or (in cases of nel followed local protocols In for confirmation of airway field termination of resuscitation) EMS records (eTable 2 placement and management of OHCA, including field termi- in Supplement 2). We chose this outcome because it re- nation ofresuscitation efforts. Patients receiving BVM venti- quires a smaller sample size than traditional ourcomes lation only (without any LT or ETI attempts) were retained (eg, survival to hospital discharge) and accommodated key infra- in their assigned treatment group per intention-to-treat elements of standard postarrest care such as therapeutic clin- principles. The trial did not prescribe clinical care at the hypothermia (targeted temperature management), early per- than receiving hospitals, including the use or replacement of the cutaneous coronary intervention, and delay of neurological rtory EMS airway, the provision of targeted temperature manage- assessment.l8,2r Secondary trial outcomes included (1) retum el for ment, percutaneous coronary intervention, or the timing of of spontaneous circulation (presence of palpable pulses . The withdrawal of life-sustaining therapy.l8 on emergency department arrival), (2) survival to hos- mber While ETI is almost exclusively an pital discharge, and (3) favorable neurological status on skill, clinicians at the Milwaukee and Port- hospital discharge (Modified Rankin Scale score <3). land sites had been trained in LT insertion.ls,2o When these EMS Other secondary outcomes included EMS airway manage- agencies were assigned to Ll select basic life support-only cli- ment course and hospital adverse events. Research coordi- tored nicians performed initial LT insertion. When assigned to ETI, nators ascertaining clinical outcomes were not blinded to s and these clinicians performed BVM ventilation until advanced life the study intervention. noni- support arrival. While postulated mechanisms influencing OHCA out- afety comes following advanced airwaymanagement include chest rtions Randomization compression interruptions and hyperventilation, the prag- The trial used cluster randomization with crossover. We matic nature of the trial precluded the formal collection and grouped the 27 EMS agencies into 13 randomization clus- analysis of chest compression and ventilation data.6'22'23 ters. Each cluster selected an a priori crossover interval of3 , sites or 5 months. Based on each cluster's selected crossover Study Compliance Benchmarks meri- interval and projected duiation of trial participation, the Benchmarks used by the study monitoring committee for as- rduct Iead statistician created a detailed a priori randomization sessing EMS agency performance in the trial are listed in eAp- IUma plan (complete with crossover dates and assigned interven- pendix 3 in Supplement 2. na at tions), with the goal of achieving balance within and across nical sites at the end of the trial. Within each cluster, treatment Data Analysis l data assignments for consecutive intervals were computer- We estimated the sample size based on the expected fre- randomized in blocks of2 to ensure balanced exposure to quency of 72-hour survival (eAppendix 4 in Supplement 2). both airway groups. Crossovers between study groups could Because we could not identify any prior reports of 72-hour occur more than once. survival after OHCA, we used data from the ROC PRIMED )rpre- Practical factors influenced the execution of the ran- trial.24,2s After limiting this analysis to US sites with active ating domization. We provided crossover notifications to each use of SGA, we estimated baseline 72-hottr survival rates of pport cluster at least 1 month prior to the scheduled crossover 16.2% for ETI and ll.lo/o for SGA, suggesting a potential rment date, aiming to initiate crossovers on the first day of a calen- effect size of 5.1%. By study team consensus, we selected a lgen- dar month. We allowed EMS agencies to align crossover more conservative value of 4.5% as the difference to power 'e not dates with training sessions, avoid weekends, and avoid the study. crossovers during the last month of the trial. Some clusters To account for patients receiving BVM only, we in- experienced delays in start-up, which required adjustments creased the baseline LT survival rate to 13.7%o. We designed ofplanned crossover dates (but not randomization groups). the trial to have 85% power to detect a 4.5yo difference in nitial If clinicians from more than 1 participating EMS agency 72-hour survival, assuming an overall 2-sided o = .O5, nser- were present on scene, the first arriving unit determined the adjusting for number of analyses (3 interim and I final) and nt 2). study treatment assignment. accommodating up to a 57o loss of precision due to cluster ly LT Among the 55 random cluster treatment group assign- randomization with crossover. While the projected mini- tonly ments. we made 2 crossover adiustments to achieve bal- mum sample size was 2612 patients (1306 per group) to na.com Jama.com JAMA August28,2Ol8 Volume32O,Number8 Research Original Investigation Initial Laryngeal Tube Insertion vs Endotracheal Intubation suruival in out-of-HosDital cardiac Arrest

allow for exclusions, loss to follow-up, and patients treated r- with BVM only, we aimed to enroll a total of 3OOO patients. Results Trial-stopping boundaries followed asymmetric 2_sided designs based on the unified family ofgroup sequential Patient Characteristics stopping rules.25'27 The trial enrolled patients from December l, 2015, through No- We analyzed the primary and secondary outcomes vember 4,2017. The duration of enrollment for each cluster on intention-to-treat bases. In cases where rescuers used ranged from ll to 23 months (eFigure 2 in Supplement 2). En- only BVM (without ETI or LT insertion), we retained the rollment clusters crossed over between interventions I to 6 patient in their assigned randomization. To quantify times. Of 384O screened patients, 3OO4 were included; l5O5 the treatment effect, we used generalized estimating equa_ assigred to initial LT and 1499 assigned to initial ETI (Figure). tions (GEEs) with an identity link and robust standard The proportion ofLT and ETI assignments varied across ran- errors, accounting for randomization cluster and number of domization clusters (eFigure 3 in Supplement 2). interim analyses. Baseline patient and airway management characteristics We assessed whether the association of airway man_ are provided in Table I and eTable 3 in Supplement 2. agement strategy with the primary outcome differed by LT and ETI protocol compliance (initial a priori-defined attempt with as_ subgroups, including initial cardiac signed airway or use of BVM only) were 95. 5o/o and,g}.ZYo,re_ rhythm, bystander-witnessed arrest, EMS response time, spectively. Elapsed time from first basic life EMS arrival to airway start support unit capability of LT insertion, time of air_ was shorter for LT than ETI (median, 9.8 vs 12.5 minutes). lni_ way placement after first rescuer arrival on scene, use of tial LT and ETI success rates (excluding BVM) were 90.3% neuromuscular blocking agents before or during airway and 51.6%. Overall LT and ETI airway success rates (ini_ insertion efforts, age, use ofvideo laryngoscopy, use ofBVM tial + rescue airway attempts) ventilation were 94.29l" and 91.5%, respec_ only, and airway placement after return of spon- tively. Clinicians at receiving emergency departments con_ taneous circulation. We assessed the influence ofthese fac_ verted 64.4"/o of EMS LT to ETI. Among patients receiving tors by evaluating each (intervention by subgroup) interac_ successful EMS ETI, emergency department clinicians per_ tion term in the primary model, formed repeat ETI in 33.1%. Outcomes of initial and rescue To assess air- the effect of deviations from random assign_ way interventions are presented in eFigure 4 inSupplement 2. ment, we conducted a per-protocol analysis, retaining only A total of 352 patients received BVM only without any cases in compliance with their assigned airway group (eg, as_ advanced airway insertion efforts. Reported reasons for the signed to ETI and received ETI or BVM). We considered in_ use ofBVM only included the patient regaining conscious- stances of BVM only to be compliant with the Drotocol be_ ness (29.3%), death prior to airway insertion attempts cause the expected course of airway management may entail (14.2o/"), j aw clenching (trismus, ll.g%), adequate BVM ventilation. ventila- tion with BVM (9.9%), arrival at emergency department To assess the effect of unbalanced randomization prior to airway insertion efforts (j.7%), and other (S.g%) within clusters, we conducted post hoc GEE analyses of the (eTable 4 in Supplement 2). intention-to-treat and per-protocol populations, adjusting for age, sex, bystander- or EMS-witnessed arrest, time to Primary Outcome EMS arrival, bystander chest compressions, and initial car_ Seventy-two-hour survival was unknown for 4 patients (0.1%). diac rhythm. We repeated post hoc analysis of the intention_ Among the remaining patients, 72-hour survival was lg.3% in to-treat population with a hierarchical model (patients the LT group vs 15.4o/o in the ETI group; accounting for ran- nested within EMS agency and EMS agency nested within domization cluster and interim randomization analyses, this difference was cluster) and a model with randomization 2.9Yo (95o/o p Cl, 0.2%-5.6%; = .O4; relative risk, t.lg CI, cluster as a fixed effect. [95% We examined the effect of random_ l.o1-1.391) (Table 2). ization order (LT first vs ETI first) by fitting a treatment by order interaction term. We also conducted as_treated analy_ Secondary Outcomes ses, classifying each case to I of3 groups according to air_ Secondary outcomes in the LT group vs ETI group were way technique received: LT, ETI, and BVM or other. We lim- return of spontaneous circulation (27.9% vs24.3%; adjusted ited as-treated comparisons to LT vs ETI. difference, 3.60/0 CI, O.3%-6.go/ol; p Missing lgs%o = .03), hospital sur_ data were flagged on data entry and reviewed vival (10.8% vs 8.1%; adjusted difference, 2.7o/o lg5yo Cl, by data entry staff for accuracy. We treated ..unknown,, O.6o/o-4.BYo; P = .O1), and favorable neurological variable categories status at dis- as informative and included these as charge (7.lVo vs 5.O%; adjusted difference, 2.1% lg5% U, separate factors in the cEE models. We considered missing O.3o/o-3.By"l P .O2). There baseline = were no statistically significant data to be missing completely at random post for differences in treatment effects in 72ihortr survival among hoc GEE models; we did not impute values. patients with a priori-defined missing subgroups (eFigure 5 in Supplement 2). data in any of the adjustment variables were excluded from the model. We used 2_sided tests with an o of Additional Analyses .05 as the threshold for statistical significance. We con_ In the per-protocol group, 72-hour survival was greater for ducted all analyses using LT the statistic;l package R version than ETI (18.3%.vs 15.4%"; risk difference, 2 S% O 3.2.5 (The R Foundation). [g5% CI, J%_ 5.7%); P = .045). TI2 JAMA August28.2Ol8 Volume32O,Numberg Jama.com : Arrest Initial Laryngeal Tube Insertion vs Endotracheal lntubation Survival in Out-of-Hospital Cardiac Arrest Original Investigation Research

Figure. Flow of Patients in the pragmatic Airway Resuscitation Trial

27 EMSagencies 1No- 13 Randomization ctusters Jster . En- 56 Ctuster enroltment to6 periods randomizeda 1505 rre). . 30' PeriodsrandomizedtoinitiatLT 26 Periods randomized to initiat Eii ran- 20 3-mo Duration 17 3-mo 0uration 8 5-mo Duration 7 5-mo Duration 2 otherduration 2 otherduration patients ;tics 1968 screened (median, 53; 1872 Patients screened (median, 45; range, 2-296lenro[ment period) range, 6-587/enrottment period) t2. ] d5- +e: PatieitsexauOeOt 373 Patients exctudedb , re- 248 Care by non-PART agency 190 Care by non-PART agency capabte of advanced tart airway capeble of advanced airway ptacem€nt > placement 151 Preexisting Ini- conditionsc 127 Preexisting conditionsc 33 Protected population 3o/o 16 Protected poputation 68 otherd ni- 74 Otherd ec- - I J.--. l5o5PatientsassignedtoinitiatLT - )n- I G;;di;isnedtoinitiatETl 1285 Received LTe I tl60 Received ETle :ng 152 Received BVMe I 2OO Received BVMe 57 Received ETlr er- 138 Received LTf 1 Receivedotherunknown ) I Received other unknown rir- airwayf airwayf :2. ! 1505 Initiat LT patients . ny included 1495rrrr InitiatilIltdr ETIE | | Datientspduclts includedtrtltuoeq I in the primary analysis in the primary ne I i anatysis i 0 Exctuded (72-h survival not known) 4 Excluded (72-h survivat not known) LS.

ts Randomization ofclusters and screening and inclusion of patients in the trial. do-not-attempt-resuscitation orders; patient with advanced airway inserted a- EMS indicates emergency medical services; ETl, endotracheal intubation; prior to EMS arrival; patients with left ventricular assist device or total artificial LT, laryngeal 1t tube; PART, Pragmatic Airway Resuscitation Trial. hea!-t; and patients with a do-not-enroll bracelet. a Cluster enrollment periods d depicted in eFigure 2 in Supplement 2. Other exclusions include major bleedingor exsanguination, obvious asphyxial Twenty-seven EMS agencies were grouped into l3 randomization clusters, cardiac arrest, interfacility transports, and traumatic etiology ofarrest. with each cluster selectingan a priori crossover interval of3 or 5 months. e Protocol comoliance. b Screened patients may have been excluded for more than I reason. r Protocol deviation. ' Preexistingconditions include preexistingtracheostomy; preexisting I n s Adverse events are summarized in Table 3. Compared with statistically significant (adjusted difference, 2.lVo 195/o CI, patients Ll in the ETI group were more likely to experience 3 -O.S%oto 4.8o/ol; P = .11; Table 2). In a hierarchical model with or more airway insertion attempts (18.9% vs 4.5%). Unsuc- patients nested within agency and agency nested within ran- cessful initial airwayinsertionwas higherfor ETI than LT (44.1% domization cluster and applying independent coffelation struc- vs 11.8%). Unrecognized airway misplacement or dislodge- ture, the difference in 72-hour survival between LT and ETI ment was higher for ETI than LT (1.8% vs 0.7%). EMS person- was 1.8% (95% CI, -0.9% to 4.5%). Ina linear regression model nel reported inadequate ventilation more often in LTthan ETI with randomization cluster included as a fixed effect, the dif- (1.8% vs 0.6%). Pneumothoraces (7.OV"vs 3.5%) and rib frac- ference in72-hour survivalbetween LTand ETIwas 1.5% (95% tures (7.0% vs 3.3%) were more common with ETI than LT. CI, -1.2o/oto 4.3%). There were no significant differences in oropharyngeal or hy- When stratifyingby order of randomization (LT first or ETI popharyngeal injury (O.2% vs O.3%), airway swelling (1.1% vs first), the differences in 72-hour survival were 2.5o/o (95o/o CI, 1.0%), pneumonia o/o or or pneumonitis (26.10/ovs22.30/.) inthe - O.9o/" Io 5.9 %) for LT fi rst an d 3.6% (95% Cl, - O.9 lo 8.2o/o) LT vs ETI groups. for ETI first (interaction P = .69). After post hoc multivariable adjustment, the difference in 72-hour survival in the per- Post-Hoc Analyses protocol analysis was not statistically significant (adjusted dif- In the intention-to-treat population, after post hoc adjust- ference, 2.3o/.l95yo CI, -O.4% to 5.1%l; P = .O9; Table 2). ment for age, sex, initial cardiac rhythm, response time, wit- In the as-treated analysis, the initial airway devices used nessed status, and bystander chest compressions, the differ- on enrolled patients were ETI in 1224 patients, LT in 1423, and ence in 72-hour survival between LT and ETI was not BVM or other in 354; there was no significant difference in

jama.com JAMA August28,2O18 Volume32O.Number8 Research Original Investigation Initial Laryngeal Tube Insertion vs Endotracheal Intubation Survival in Out-of.Hospital Cardlac Arrest

Table l. Characteristics of Patients Included in Intention.to.Treat population

Endotracheal LaryngeaI Tube Intubation Characteristic (n = r50s) (n = 1a99) Age, median (lQR), y 64 (s3-76) 64 (s3-75) Mate, no./total No. (%) 928/1s03 (61.7) 901/1499 (50.1) Witnessed arrest, no./totat No. (%) n = 1357 n = 1399 EMS witnessed 180 (13.3) 179 (12.8) Bystander witnessed sr7 (37.7) s29 (37.8) Not witnessed 665 (49.1) 691 (49.4) Unknown" 148 (9.8) 100 (6.7) Bystander chest compressions, no./No. (%) n = 1258 n = 1279 Yes 698 (ss.s) 709 (ss.4) No s60 (44.s) 570 (44.6) Unknown' 247 (16.4) 220 (1.4.7) Time from dispatch to first arrivat of EMS Median (lQR), min s.0 (3.9-6.3) s.3 (4.1-6.8) s4 min, no./total No. (%) 40817444 (28.3) 30s/r4o5 (21..7) Unknown 61 (4.1) e4 (6.3) Time between EMS arrivat and start of chest compressions Median (lQR), min 2.1 (1.1-3.8) 2.1 (i.0-3.7) s10 min, no./totat (%) No. 124311347 (92.3) 1189/1279 (93.0) First electrocardiogram rhythm, no./totat No. (%) Shockabte rhythm (ventricular f ibriltation, 301 (20.0) 270 (18.0) ventricu[ar tachycardia, or detivery of AED shock)

Nonshockabte (asystole, pulsetess 1160 (77.L) 1197 (79.s) €tectricaI activity, or AED nonshockabte) Abbreviations: AED. automated 0ther external defibrillator; 44 (2.9) 32 (2.1) EMS, emergency medical Epinephrine administered before hospitat arrivat, 138s (92.0) 140s (93.7) services; lQR. interquartile range. no./total No. (%) a For "unknown" values, denominator Compliance withassigned airway intervention, 1437 (95.s) 1360 (90.7) no./totat No. (%)b is total cases in group. o Transported to hospitat, no./totat (%) Episodes were considered No. 906 (50.2) 889 (se.3) compliant if the randomized airway Hospital procedures, no./total No. (%)c was initially attempted or if only Therapeutic hypothermia 2421460 (s2.6) 18s/400 (46.3) bag-valve-mask was used. Episooes were considered noncomDliant if Coronary catheterization 1091460 (23.7) 731400 (18.3) another airway device was used. Patients per randomization clusterd c Percentage ofthose transported Mean lro 115 to hospital and survived for Median (range) at least t hour. 94 (3-314) 66 (12-382) d Total of13 randomization clusters.

72-hour survival between those receiving initial LT and ini- tial (16.0% p ETI vs I3.5%; = .07) (eTable 5 in Supplement 2). Discussion Treatment effects varied among randomization clusters (eFigure 6 in Supplement 2) and (eFigure EMS agencies 7 in In this trial of 3OO4 adults with OHCA, a strategy of initial Supplement 2) and showed atendencytoward favoringLTonly LT was associated with modest but significantly greater in clusters with lower baseline ETI survival. 72-hour survival than a strategy of initial ETI. There were The primary outcome (72-hour survival) was missing for also statistically significant associations with survival to 4 of 3OO4 enrolled patients (O.t%), all assigned to ETI. hospital discharge and favorable neurological status at hos- Because of the low number of missing cases, we did not pital discharge that favored the LT group. The trial offers apply multiple imputation. Arnong the patients 4 with miss_ preliminary observations that may potentially guide EMS ing 72-hour outcome, there were 16 possible combinations of airway management practices and serve as the 72-hour basis for survival; only I (all 4 patients surviving to 72 hours) future research. would have altered the primary trial results. Given the The trial demonstrated the effectiveness of an LT-based observed 75.4%o72-hour survival rate in the ETI group, the strategy of advanced airway management, probability not the efficacy of of all 4 cases surviving to 72 hours was 0.O6910. the LT airway device. OHCA resuscitation reouires the careful

JAMA August28,2O18 Volume32O,Number8 Jama.com Initial Laryngeal Tube Insertion vs Endotracheal Intubation Survival in Out-of-HosDital Cardiac Arrest Originallnvestigation Research

Table 2. Outcomes of Patients Included in the primary and Secondary Analyses

No. (%)

Endotracheal Laryngeal Tube lntubation Difference, Characteristic (n = ls05) (n: 1499) %(9s%ct)' PValue Primary Outcome

Survival to 72 h (intention-to-treat poputation) (18.3) 27s 230/149s (1s.4) 2.9 (0.2 to 5.6) .04 Secondary Outcomes

Return of spontaneous circutation (27.9) 420 36s (24.3) 3.6 (0.3 to 6.8) .03 on emergency dep.artment arrivat Survival to hospital discharge 163/1s04 (10.8) 12rl149s (8.1) 2.7 (0.6 to 4.8) .01 Favorab[e neurologic status at discharge 107/1s00 (7.1) 7sl149s (s.0) 2.1 (0.3 to 3.8) .02 (Modjfied Rankin Scale score s3)

Modified Rankin Scate score n = 1500 n = 1495 0-No symptoms 17 (1.1) 14 (0.9) 1-No signif icant disabitity 32 (2.1) 29 (1.e) 2-Stight disabitity 22 (1.s) 12 (0.8) 3-Moderate disability 36 (2.4) 20 (1.3) 4-Moderately severe disability 26 (1.7) 24 (1.6) 5-Severe disability 26 (1.7) 22 (1.s) 6-Dead 1341 (89.4) 1374 (91.9) AdditionaI Analyses

Per-protocoI analysis-survivaI to 72 h 263/1437 (18.3) 209/13s5 (15.4) 2.9 (0.1 to 5.7) .045 post Intention-to-treat hoc adjusted anatysisb 2.1 (-0.5 to 4.8) .11 post Per-protocol hoc adjusted anatysisb 2.3 (-0.4 to 5.1) .09 a primary b For the analysis, the estimated difference in 72-hour survivar Post hoc analyses adjusted for age, sex, rhythm, response time, witness accounted for interim monitoring and clustering via robust standard errors. status, and bystander chEst compressions. A total of 163 patients were All other comparisons accounted for clustering. omitted from post hoc models due to missing data.

Table 3. Out-of-Hospital and In-Hospital Adverse Events.

Endotracheal Laryngeal Tube Intubation Difference, Characteristic (n = 1505) (n = 1499) % (gs%ct) P Value Out-of -Hospital Adverse Events Multiple (:3) insertion attemptsb

InitiaI airway 6i 13s3 (0.4) 18/1299 (1.4) -0.9 (-1.7 to -0.2) .01 Across alt airways 61/13s3 (4.s) 24sl1299 (18.9) -14.4 (-17.0 to -11.7) <.001 Unsuccessf uI insertionb First airway technique 1s9/13s3 (11.8) 573/1299 (44.r) -32.4 (-35.5 to -29.1) <.001 " Out-of-hospital adverse events Alt airway techniques 78/13s3 (s.8) 111/1299 (8.s) -2.8 (-4.8 to -0.8) .01 were based on emergency medical Unrecognized airway misplacement (0.7) 10/13s3 24/1299 (1.8) -1.1 (-2.0 to -0.3) .01 services personnel reports. or airway dislodgement In'hospital adverse events were Inadequate ventilation 2slr3s3 (1.8) 8i 1299 (0.6) 1.2 (0.3 to 2.1) .01 determined from review of In-HospitaI Adverse Events medical records.

D Pneumothorax (first chest x-ray). 17l48s (3.s) 301428 (7.0) -3.6 (-6.s to -0.7) .02 Excludes cases receiving (first bag-valve-mask ventilation only. Rib fractures chest x-ray)c 15/48s (3.3) 301428 (7.0) -3.8 (-6.9 to -0.7) .01 'Includes patients who were OropharyngeaI or hypopharyngeaI injury 11460 (0.2) 1/400 (0.3) 0 (-0.7 to 0.6) .92 (first 24 h)o admitted to emergency department and underwent a chest x-ray. Airway swetling or edema (first 24 h)d s1460 (1.r) 4/400 (1.0) 0.1 (-1.3 to 1.4) .90 d Includes patients who were Pneumonia or aspiration pneumonitis 1201460 (26.1) (22.3) (-2.1 89i400 3.7 to 9.6) .11 admitted to emergency department (first 72 h)d and survived for at least I hour. coordination of multiple interventions, including initiation EMS arrival to first airway attempt was 2.7 minutes shorter in and maintenance of chest compressions, controlled ventila- the LT than ETI group. Also, LT required fewer insertion tion, vascular access, drug administration, and defibrillation. attempts than ETI. This pragmatic trial did not assess mecha- The simpler LT technique may better integrate with and nisms underlying the effect of airway type on chest compres- facilitate these other treatments. Although the 2 groups sion quality (in particular, chest compression continuity), reported similar procedural duration, the elapsed time from which may potentially influence OHCA outcomes.s'28 iama.com JAMA August28,2Ol8 Volume32O,Number8 775 Research Original Investigation Initial Laryngeal Tube Insertion vs Endotracheal Intubation Survival in Out-of-Hospital Cardiac Arrest

The ETI success rate of51% observed in this trial is lower BVM and ETI, but care was rendered by physician-staffed than the 9O7o success rate reported in a meta-analysis.2s The EMS units, a model less common in the United States and reasons for this discordance are unclear. Prior reports ofhigher countries with similar paramedic-based EMS systems.3s success rates may be susceptible to publication bias. Another In the United Kingdom, enrollment has been completed in possibility is that some medical directors encourage early res- Airways-2, a trial comparing i-gel SGA with ETI on OHCA cue SGA use to avoid multiple unsuccessful intubation at- outcomes.36 The current trial focused on LT, which is more tempts and to minimize chest compression interruptions.s Few commonly used in the United States. of the study EMS agencies had protocols limiting the number While prior studies suggest higher survival with BVM of allowed intubation attempts, so the ETI success rate was not than with advanced airway devices, similar inferences the result of practice constraints. While the ETI proficiency of should not be made based on the as-treated analysis of this study clinicians might be questioned, the trial included a di- trial. The BVM-only group exhibited higher rates of wit- verse range of EMS agencies and likely reflects current prac- nessed arrest, bystander chest compressions, and shockable tice. It is not clear whether clinicians with more advanced ETI rhythms than LT or ETI, and almost a third regained con- skills or experience would have altered these results. How- sciousness prior to advanced airway intervention, suggesting ever, this pragmatic trial highlights the outcomes of care re- influence from resuscitation time bias.37 These and other sulting from existing EMS airway clinical and training prac- biases cannot be overcome by post hoc analytic techniques. tices; supplementing the trial with specialized airway A randomized trial comparing BVM and LT would be needed management training would have limited the generalizabil- to assess their relative efficacv. ity of the findings. Some limitations of a cluster-crossover design include Limitations imbalance in patient allocation, group baseline characteris- This study has several limitations. First, the pragmatic trial tics, and variations in within-cluster treatment effects. evaluated strategies ofLT and ETI under existing clinical pro- Post hoc adjustment for these factors influenced the tocols and educational practices without additional training observed associations with 72-hour survival, underscoring or quality improvement monitoring, Second, the stipulations the importance of even small imbalances. Post hoc analyses of the grant award influenced many elements of the study also suggested that the benefit of LT may have been ampli- design such as limiting the available sample si2e. Third, the fied in clusters with lower baseline ETI 72-hour survival. The trial could not assess the influence of chest compression or reasons for these intercluster differences are unknown. Post ventilation quality. Fourth, the trial focused on LT use and hoc analyses are extremely difficult to interpret in the con- not other SGAs. Fifth, many elements of the trial were not text of a clinical trial. While cluster-crossover designs have blinded, including the interventions, allocation, crossover been successfully used in trials enrolling patients with OHCA, timings, and outcomes ascertainment, and adjustments were additional study must evaluate the nuances ofthis approach made to the crossover plan to balance allocation. Sixth, these in the context of airway management.2a'3o results pertain to the out-of-hospital environment and may These results contrast with prior studies of OHCA air- not apply to the in-hospital setting. way management. Observational studieS have reported higher survival with ETI than SGA, but they were nonran- domized, included a range of SGA types, and did not adjust Conclusions for the timing of the airway intervention.s,lo,3l-34 A trial of 830 children found no difference in survival or neurological Among adultswith OHCA, a strategy ofinitial LT insertionwas outcomes between those randomized to BVM-only ventila- associated with significantly greater 72-hour survival com- tion vs BVM+ETI, but the study occurred in 1994-1992 used pared with a strategy ofinitial ETI. These findings suggest that clinicians who were newly trained in pediatric ETI, and LT insertion may be considered as an initial airway manage- included a range of medical conditions in addition to ment strategy in patients with OHCA, but limitations of the OHCA.l2 A recent trial of 2043 adult OHCA cases in France pragmatic design, practice setting, and ETI performance char- and Belgium found no OHCA survival differences between acteristics suggest that further research is warranted.

ARTICLE INFORMATION Medical Center, Dallas (ldris, Owens); Department (Sternig); National Heart, Lung, and Blood Institute, of Emergency Medicine, Saint Vincent Hospital, Bethesda, Maryland (Sopko); Department of Accepted for Publication: May4. 2O18. Allegheny Health Network, Erie, Pennsylvania Medicine, Johns Hopkins University School of Author Affiliations: Department of Emergency (Carlson); University of Pittsburgh. Pittsburgh, Medicine, Baltimore, Maryland (Weisfeldt); Medicine. University ofTexas Health Science Center Pennsylvania (Carlson, Puyana, Brienza); Departments of Emergency Medicine and at Houston (Wang); Department of Emergency Department of Emergency Medicine, Medical Medicine, Harborview Center for Prehospital Medicine, University of Alabama at Birmingham College of Wisconsin, Milwaukee (Colella, Emergency Care, University of Washington, (Wang, Stephens. P. R. E. Gray, C. Gray); Clinical Aufderheide); Medstar Mobile Healthcare, Seattle (Nichol). Trials Center, Department of Biostatistics, (Richmond); Fort Worth, Texas currently with Contributions: Drs Schmicker and May had University of Washington, (Schmicker, Author Seattle Emergency Medicine, John Peter Department of full access to all ofthe data in the study and take Herren, May); Department of Emergency Medicine, Smith Health Network, Fort Worth, Texas responsibility for the integrity of the data and the Oregon Health and Science University, Portland (Richmond); Clackamas Fire District #1, Milwaukie. (Daya, accuracy ofthe data analysis. Hansen); Department of Emergency (Verkest); Oregon Milwaukee County Office of Concept ond design: Wang, Daya, Stephens, Herren, Medicine, University of Texas Soutnwestern Emergency Management, Milwaukee, Wisconsin Richmond, Sternig, May, Weisfeldt, Nichol.

Tt6 JAMA August28,2018 Volume32O,Number8 jama.com I Research resr Initial Laryngeal Tube lnsertion vs Endotracheal Intubation Survival in Out-of-Hospital Cardiac Arrest Original Investigation

'ed Acquisition, onolysis, ot interpretotion of doto: manuscript for publication (formal approval ofthe on survival and neurological outcome: a controlled nd Wang, Schmicker, Daya, ldris, Carlson, Colella, final manuscript by the institute). Ambu Inc had no clinical trial. lAM,4. 2OOO;283(5):783-79O. Hansen, Richmond, Puyana, Auderheide, role in the design and conduct of the study; Herren, 13. Frascone RJ, Russi C. Lick C, et al. Comparison collection, management, analysis, and R. Gray, P Gray. Verkest. Owens, Brienza, May, of prehospital insertion success rates and time to interpretation of the data: preparation, revieW or ln sopko, Weisfeldt, Nichol. insertion between standard endotracheal the monuscnpt: Wang, Schmicker, approval ofthe manuscript; and decision to submit CA Drofting of intubation and a supraglottic airway. Resuscitotton' Daya, Stephens, Carlson. Auderheide, May. the manuscript for publication. )re 2Oll;82(12):1529-1536. Weisfeldt, Nichol. Disclaimer: The content is solely the responsibility 14. Benger JR, Voss S, Coates D, et al. Randomised Criticol revision of the monusctipt for importont and does not necessarily represent ofthe authors comparison ofthe effectiveness ofthe laryngeal /M intellectuol content; Wang. Schmicker, Daya, ldris, NHLBI or NlH. the official views of the the mask airway supreme, i-gel and current practice in Carlson. Colella, Herren, Hansen, Richmond, :es Meeting Presentationr This study was presented the initial airway management of prehospital Puyana, Auderheide, R. Gray, P Gray, Verkest, at the Society for Academic Emergency Medicine cardiac arrest (REVIVE-A|rways): a feasibility study his Owens, Erienza. Sternig, May, Sopko. Annual Meeting; May 16, 2O18; Indianapolis, research protocol. BMJ Open. 2O133(2):eOO2467. 'it- Weisfeldt. Nichol. Indiana. lle Stotisticol onolysis; Schmicker, May. 15. Wang HE, Prince Dl(, Stephens SW et al. Design Additional Information: A list of the individuals and imolementation of the Resuscitation Outcomes ,n- Obtoined funding: Wang, Stephens. ldris, Herren, May, Weisfeldt, Nichol. and entities that were involved in the study is Consortium Pragmatic Airway Resuscitation Trial ,ng Administrotive, technicol, or moteriol suwort: available in Supplement 2. (PART). Resuscitotion. 2016lOl:57-64. ler Wang, Daya. Stephens, ldris, Colella, Herren, t6. Deoartment of Health and Human Services. Brienza. REFERENCEs es. Richmond, Puyana, Verkest, Owens. Low-cost, pragmatic, patient-centered randomized Sternig, May, Weisfeldt, Nichol. intervention trials (uH2/uH3). ed 1. Benjamin EJ. Virani SS, Callaway CW, et ah controlled Supervision: Wang, Daya, Stephens, ldris, American Heart Association Council on https://grants.nih.gov/grants/guide/rfa-f iles Carlson, Colella, Hansen, Richmond, Epidemiology and Prevention Statistics Committee /RFA-HLl4-Ol9.html. Published 2013. Accessed May, Nichol. and Stroke Statistics Subcommittee. Heart Disease April 3. 2O18. a report from Conflict of Interest Disclosures: All authors have and Stroke Statistics-2018 Update: 17. Loudon K, Treweek 5, Sullivan F, Donnan P, 2Ol8; ial completed and submitted the ICMJE Form for the American Heart Association. C,icurotion. Thorpe KE, Zwarenstein M. The PRECIS-2 tool: Disclosure of Potential Conflicts of Interest. 137(12):e67-e492. designing trials that are fit for purpose. BMJ.2015: ro- grants Dr Wang reported receiving from the 2. Katz SH, Falk JL. Misplaced endotracheal tubes 35O:h2147. ng National Institutes of Health (NlH)/National Heart, by paramedics in an urban emergency medical 18. Callaway CW, Donnino MW Fink EL, et al. Lung. and Blood Institute (NHLBD and providing Ins services system. A nn Emerg Med.2OO1;37(1):32-37 Part 8: post-cardiac arrest care: 2O15 American research consultation for Shire Inc. Mr Schmicker: dy 3. Wang HE, Yealy DM. How many attempts Heart Association Guidelines update for Drs Daya, Aufderheide, and May; and Mrs Herren are required to accomplish out-of-hospital cardiopulmonary resuscitation and emergency he reported receiving grants from the NHLBI. endotracheal intubation? Acod Emerg Med. 2o06t cardiovascuf ar care . Circulotion. 2O15i132('lSXsuppl or Dr ldris reported receiving grants from the NlH, 13(4):372'377. 2):5465'5482. nd University of Alabama, and Heartsine Inc and being an uncompensated member of 4. Wang HE, Kupas DF, Paris PM. Bates RR, Yealy 19. Ochs M. Vilke GM, Chan TC, Moats T, Buchanan lot Heartsine Inc's scientific advisory board. Dr Carlson DM. Preliminary experience with a prospective, J. Successful prehospital airway management by /er reported receiving grants from the NHLBI and multi-centered evaluation of out-of-hospital EMT-Ds using the combitube. Prehosp Emerg Core. ]re American Heart Association for intubation research. endotracheal intubation. Resuscitdtion. 2OO3;58(l): 20OO;4(4):333-337 Dr Sopko reported being an employee ofthe NlH. 49-58. RG. The effect of combitube )se 20. Cady CE, Pirrallo Dr Nichol reported receivingsalary support 5. Wang HE, Simeone SJ, Weaver MD, Callaway CW. use on paramedic experience in endotracheal ay grants from Medic One Foundation; from NlH, Interruptions in cardiopulmonary resuscitation intubation. Am J Emerg Med. 2OO5;23(7):858-871. Agency for Healthcare Research and Quality, and from paramedic endotracheal intubation. Ann 21. Peberdy MA, Callaway CW, Neumar RW, et al; US Food and Drug Administration; and contracts E nerg Med. 2OO9;54(5):645-652.eI. American Heart Association. Part 9: post-cardiac from Abiomed. GE Healthcare. and ZOLL Medical 6. Aufderheide TP, Lurie KG. Death by arrest care: 201O American Heart Association Corp, and providing consultancy to ZOLL hyperventilation: a common and life-threatening guidelines for cardiopulmonary resuscitation and Circulation. No other disclosures problem during cardiopulmonary resuscitation. Crit emergency cardiovascular care. Circulotion. 2O1O: were reported. Core M ed. 2OO4:32(9Xsuppl):5345-5351. 122(18Xsuppl 3):5768-5786. fd5 Funding/Supportr This study was supported by 7. Wang HE, Kupas DF, Hostler D, Cooney R, 22. Aufderheide TP, Sigurdsson G. Pirrallo RG, et al. award UH2/UH3-H1125153 from the NHLBI. The m- Yealy DM, Lave JR. Procedural experience with Hyperventilation-induced hypotension during Resuscitation Outcomes Consortium institutions out-of-hosDital endotracheal intubation. Crit Cote cardiopulmonary resuscitation. Circulotion 2OO4: rat participating in the trial were supported by a series Med. 2OO5;33(8):1718-1721. 109(16):19501965. of cooperative agreements from the NHLBI, he including 5UOl HLO//863 (University of 8. Ritter SC, Guyette FX. Prehospital pediatric l(ing 23. Benoit JL, Prince Dl(, Wang HE. Mechanisms Data Coordinating Center), H1077866 LT-D use: a pilot study. Prehosp Emerg Core.2O11l linking advanced airway management and cardiac ar- Washington (Medical College of Wisconsin), H1O77871 15(3):4Ol-4O4. arrest outcomes. Resuscitdtion. 2015 :93:124-127 (University H1077873 (Oregon of Pittsburgh), 9. Wang HE, Szydlo D, Stouffer JA, et al; 24. Stiell lG. Nichol G, Leroux BG, et al; Roc Health and Science University), HLO7788l Roc Investigators. Endotracheal intubation versus Investigators. Early versus later rhythm analysis in (University of Alabama at Birmingham). and supraglottic airway insertion in out-of-hospital patients with out-of-hospital cardiac atrest. N EngrJ (University of Texas Southwestern HL077887 cardiac arrest. Resuscitotion. 2O12i83(9)10611066, M e d. 2011 ;365 (9 :7 a7'7 97 Medical Center/Dallas). Ambu Inc provided lO. McMullan J. Gerecht R, Bonomo J, et al; 25. Aufderheide TP. Nichol G, Rea TD' et al; laryngeal tube airways to replace equipment used CARES Surveillance Group. Airway management Resuscitation Outcomes Consortium (ROC) by emergency medical services (EMS) agencies and out-of-hospital cardiac arrest outcome in the Investigators. A trial of an impedance threshold duringthetrial. CARES registry. Res uscitotion. 2014:85(5):617-622. device in out-of-hospital cardiac arrest. N Engl J Med. Role ofthe Funder/Sponsor: The NHLBI had 2O1l:355(9)r798-806. ll. Benoit JL, Gerecht RB, Steuerwald MT, the following roles in the study: design and McMullan JT. Endotracheal intubation versus 26. l(ittelson JM, Emerson SS. A unifying family of conduct ofthe study; review, advising, and supraglottic airway placement in out-of-hospital group sequential test designs. Biometrics. 1999: approval of study design; participation in cardiac arrest: a meta-analysis. Resuscitotion. 2015: ss(3):874-882. monitoring enrollment progress. assembly of data 93:2O'26. and safety monitoring board; preparation, review 27. Pampallona S, Tsiatis M. Group sequential hypothesis or approval of the manuscript (participation of 12. Gausche M. Lewis RJ, Stratton SJ, et al. Effect of designs for one-sided and two-sided provision in favor of coauthor Dr Sopko); and decision to submit the out-of-hospital pediatric endotracheal intubation testing with for early stopping

777 jama.com JAMA August28,2Ol8 Volume32O,Number8 Research Original Investigation Initial Laryngeal Tube Insertion vs Endotracheal Intubation Survival in Out.of-Hospital Cardiac Arrest

the null hypothesi s. J Stot P[on lnference. 1994;42: intubation for the pre-hospital treatment of 35. Jabre P, Penaloza A, Pinero D, et al. Effect of l9-35. doi:lO.lO16/0378-3758(94)90187-2 out-of-hospital cardiac arrest. Crit Core. 2Olll5(5): bag-mask ventilation vs endotracheal intubation R236. during cardiopulmonary resuscitation on 28. Kurz MC, Prince Dl(. Christenson J. et al; ROC neurological outcome after out-of'hospital Investigators. Association of advanced airway 32. Hanif MA, Kaji AH, Niemann Jl Advanced cardiorespiratory arrest: a randomized clinical trial. device with chest compression fraction during airway management does not improve outcome of IAMA. 2Ol8;319(8) :77 9 -7 87. out-of-hospital cardiopulmonary arrest. Resuscitotion. out-of-hospital cardiac arrest. Acod Emerg Med. 2Ol6:98:35-40. 201017(9):926-931. 36. Taylor J, Black S, J Brett S, et al. DesiSn and imDlementation of the AIRWAYS-2 trial: 29. Hubble MW Brown L, Wilfong DA, Hertelendy 33. Hasegawa K, Hiraide A, Chang Y Brown DF. a multi-centre cluster randomised controlled trial of A. Benner RW. Richards ME. A meta-analysis of Association of prehospital advanced eirway the clinical and cost effectiveness of the i-gel prehospital airway control techniques part l: management with neurologic outcome and survival supragiottic airway device versus tracheal orotracheal and nasotracheal intubation success in patients with out-of-hospital cardiacaftesl. JAMA. intubation in the initialairway management of out rates. Prehosp Emerg Core. 2010;14(3):377 -4O1. 2Ol3;309(3):257'265. of hospital cardiac arrest. Resuscitotion. 2O16; 30. Nichol G, Leroux B, Wang H, et al; ROC 34. Park MJ, l(won WY. Kim K, et al. Prehospital lO9:25-32. Investigators. Trial of continuous or interrupted ,supraglottic airway was associated with good 37. Andersen LW, Grossestreuer AV, Donnino MW chest compressions during CPR. N Engl J Med.2015; neurologic outcome in cardiac arrest victims "Resuscitation time bias": a unique challenge for 373(23)2203-2214. especially those who received prolonged observational cardiac arrest research. Resuscitotion cardiopulmonary resuscitation. Acod Emerg Med. 31. Kajino K, lwami T, l(itamura I et al. Comparison 2018:125:79'82. :'l 46 4'1 47 3. of supraglottic airway versus endotracheal 7Q17 ;24(12)

77a JAMA August28.2018 Volume32O,Number8 jama.com Research

JAMA I Original lnvestigation Effect of a strategy of a supraglottic Airway Device vs Tracheal Intubation During Out-of-Hospital Cardiac Arrest on Functional Outcome .te t? (": The AIRWAYS-2 Randomized Clinical Trial I

Jonathan R Benger, MD; Kim l(irby, MRes; sarah Black, DClinRes; stephen J. Brett, MD; Madeleine Clout, BSc; Michelle J. Lazaroo, MSc; Jerry P' Nolan, MBChB; Barnaby c. Reeves, DPhil; Maria Robinson, Most; Lauren J. scott, Msc; Helena smartt, phD; Adrian south, BSc (Hons); Elizabeth A. Stokes. DPhil; Jodi Taylor, phD; Matthew Thdmas, MBChB; phD; Sarah Voss. Sarah Wordsworth, phD; Chris A. Rogers, phD

EditorialpageT6l IMPoRTANcE l! The optimal approach to airway management during out-of-hospital cardiac arrest is unknown. !! Related article page769 fi Supplementalcontent oBJEcrlvE To determine whether a supraglottic airway device (SGA) is superior to tracheal (Tl) intubation as the initial advanced airway management strategy in adults with nontraumatic out-of-hospital cardiac arrest.

DESIGN' SETTING' AND PARTtcIPANTS Multicenter, cluster randomized clinicaltrialof panmedics from 4 ambulance services in England respondingto emergencies for approximately 2l million people. Patients aged l8 years or older who had a nontraumatic out-of-hospital cardiac arrest and were treated participating by a paramedic were enrolled automatically under a waiverof consent between June 2015 and August 2Ol| follow-up ended in February 2olg.

INTERVENT|oNS Paramedics were randomized ll to use Tl (764 paramedics) or sGA (759 paramedics) as their initial advanced airway management strategy.

MAINoUTcoMESANDMEASURES Theprimaryoutcomewasmodified RankinScalescoreathospital discharge or30 days after out-of-hospitalcardiac arrest, whichever occurred sooner. Modified Rankin Scale score was divided into 2 ranges: O-3 (good outcome) or 4-6 (poor outcome: 6 = death). Secondary outcomes included ventilation success, regurgitation, and aspiration.

REsuLTs A total of 9296 patients (4886 in the sGA group and 44lo in the Tl group) were (median enrolled age, 73 years; 3373 were women [36.3%]), and the modified Rankin scale score was known for 9289 patients. In the sGA group, 311 of 4gg2patients (6.4%) had a good (modified outcome Rankin scale score range, o-3) vs 3oo of 4407 patients (6.g%) in the Tl group (adjusted risk difference [RD], -0.6% lgs%ct, -15yotooAo/ol). Initial ventilation was successful in 4255 of 4868 patients (874%) in the sGA group compared with 3473 of 4397 patients (79.O%) in the Tt group (adjusted RD, 8.3% IgS%Cl,6.30/otolO.2%ol). However, patients randomized to receive Tl were less likely to receive advanced airway managemenr (3419 patients of 4404 [77.6%] vs 4t6t of 4883 patients [85.2%] in the sGA group). Two of the secondary outcomes (regurgitation and aspiration) were not significantly different groups between (regurgitation: 1269 of 4g65 patients [26.]%] in the sGA group vs 1072 of 4372 patients 124.5%l in the Ttgroup; adjusted RD,t.4%l9S%Ct, -0.6%to3.4%); aspiration: 729 of 4824 patients [i5.1%] vs 647 of 4337 patients li4.9o/ol, respectively; adj usted RD, O.1 % [95% Ct, -1.5o/o to 1.Bo/o]).

coNcLUstoNs AND RELEVANcE Among patients with out-of-hospital cardiac arrest, Author Affiliations: Author randomization to a strategyof advanced airway management with a supraglottic airway device affiliations are listed atthe end ofthis article. compared with tracheal intubatioir did not result in a favorable functional outcome at 30 days. Corresponding Author: Jonathan R. Benget MD, Faculty of Health and TRTAL REGTSTRATTON ISRCTN ldentifier: og256llg Applied Sciences, University of the West of England, Glenside Campus, Bristol 8516 1DD, England (onathan JAM A. 2018:320{8):779-791. doi:l O.lOOl/jama.2Ot Bl l597 [email protected]).

,3x,0 Research Original Investigation Effects of a Supraglottic Airway Device vs Tracheal Intubation After Out-of-HosDital Cardiac Arrest

ut-of-hospital cardiac arrest is common, sudden, and often fatal. During 2014, emergency medical Key Points services (EMS) in England attempted resuscitation Question Does an initial strategy of a supraglottic airway in almost 30 OOO people; only 25% achieved a return of device for advanced airway management during nontraumatic spontaneous circulation and 8x were discharged alive from out-of-hospital cardiac arrest result in a better functional outcome the hospital.r compared with tracheal intubation? Few advanced life support therapies have been shown to Findings In this cluster randomized clinical trial that included improve outcome following out-of-hospital cardiac arrest.2 1523 paramedics and 9296 patients with out-of-hospital cardiac arrest, There is a lack of data from high-quality randomized clinical favorable functional outcome (modified Rankin Scale score in trials (RCTs), which are challenging to conduct in patients with O-3 range) at hospital discharge or after 3O days (if still out-of-hospital cardiac arrest. Consequently, many current hospitalized) occurred in 5.4% of patients in the supraglottic clinical recommendations are based on observational studies airway group vs 6.8% of patients in the tracheal intubation group, and expert consensus.3 a difference that was not statistically significant. Optimal airway management during out-of-hospital car_ Meaning In this study, a strategy of using a supraglottic airway diac anest is a key area of uncertaintybecause there is verylittle device for advanced airway management did not provide high-quality research on which to base treatment recom- a superior functional outcome. mendations.4 Options range fiom basic or minimal airway in- tervention to early advanced procedures that require training the patient's side; and (4) resuscitation was commenced or con- and expertise. tinued by emergency medical services personnel. The advanced procedure oftracheal intubation has been The patient exclusion criteria were (l) detained by considered a definitive airway management technique.s Her Majesty's Prison Service; (2) previously recruited to the However, large observational studies (including >lOO OOO trial (determined retrospectively); (3) resuscitation deemed in- patients) have consistently favored basic airway manage_ appropriate (using guidelines from the Joint Royal Colleges ment (eg, bag-mask ventilation) over tracheal intubation.6t The Ambulance Liaison Committeer2); (4) advanced airway al- introduction ofa supraglottic airway device offers an alterna_ ready in place (inserted by another paramedic, physician, or tive advanced airway management technique during out-of_ nurse) when a paramedic participating in the trial arrived at hospital cardiac arrest. the patient's side; (5) known to be enrolled in another prehos- Insertion of a supraglottic airway device is simpler and pital RCT; and (6) the patient,s mouth opened less than 2 cm. faster than tracheal intubation,8 proficiency and requires less Paramedics could not be blinded to their allocation and training and ongoing practice.s Observational evidence has mechanisms were required to avoid the risk of differential re- suggested a possible survival advantage for tracheal intuba- cruitment by paramedics based on the patient,s perceived likely tion compared with a supraglottic airway device.ro However, outcome. Therefore, every eligible patient treated by a par- a large-scale RCT is required to identify the optimal approach ticipating paramedic was automatically enrolled in the study to advanced airway management during out-of-hospital car- under a waiver ofconsent provided by the conflrdentiality ad- diac arrest. visory group (reference No. l4lCAG/lO3O). The objective of this trial was to estimate the between- Ethics review and approval was provided by the South group difference in modified Rankin Scale score at hospital dis- Central-Oxford C research ethics committee (reference No. charge or 30 days after out-of-hospital cardiac arrest for pa- l4ls0ll2l9), which included a process of written informed tients treated by paramedics randomized to use either a consent for participating paramedics. A disadvantage of supraglottic airway device or tracheal intubation as their ini- automatic enrollment was that enrolled patients might not be tial advanced airway management strategy. treated according to the study protocol if the enrolling para- medic could not recall the protocol details (an out-of-hospital cardiac arrest is a relatively rare event) or ifthe paramedic Methods mistakenly deemed the patient to be ineligible.

Study Design and Paramedic and patient populations Randomization The trial protocol and statistical analysis plan for this multi- Because out-of-hospital cardiac arrest requires immediate center,- cluster RCT appear in Supplement l; the trial protocol treatment, randomizing patients at the point of out-of- has been published.ll paramedics were recruited from 4large hospital cardiac arrest was considered impractical. There- EMS provider organizations (ambulance services) in England, fore, paramedics were randomized to use l of the 2 advanced which respond to emergencies for approximately 21 mil- airway management strategies for the eligible patients that they lion people (40% of England,s population). The trial pop- treated (Figure l). This design created many clusters with a ulation was adults who had a nontraumatic out-of-hosoital small average number of patients per paramedic that mini- cardiac arrest. mized the effect of intracluster correlation and lowered the risk The patient inclusion criteria were (l) known or believed of chance imbalances between groups. to be aged 1B years or older; (2) nontraumatic out-of-hospital Paramedics were randomized in a l:l ratio using a purpose- cardiac arrest; (3) treated by a paramedic participating in the designed secure internet-based system. The compurer- trial who was either the first or paramedic second to arrive at generated random sequence was done in advance using varying

.780 JAMA August28,2olg Volume32O,Numberg Jama.com rc Arrest Effects of a Supraglottic Airway Device vs Tracheal Intubation After out-of-Hospital cardiac Arrest Original Investigation Research

Figure l. Flow of Study Paramedics and patients

2041 Paramedic ctusters expressed interest

464 Did notschedutetraining > 48 Schedutedtrainingbutdidnotattend 6 Attended training but did not consent l3 ro paftrctpate t,

1523 Paramedic clusters randomizeda

l2 789 Patients with out-of-hospitat cardiac arrest attended 13 587 p.ti.n* *itt' ori-of-mspitaf paramedic crrOirc arrest rUanO.a nu by randomized to tracheat intubation paramedic randomiz.d to :uqtqolll! li*.y tI.9 -! v 6334 Resuscitation of patient not atte;;d. 6580 Resuscitation of patient not attemptedb 2001 Futite 2073 Futite 1935 Rigormortis 1983 Rigormortis 1122 Patient's decision ll97 Patient,s decision 947 Hypostasis 993 Hypostasis 241 Deathexpected 243 Death expected 72 :on- Decomposition 76 oecomposition 35 Craniatdestruction 49 Cranial destruction 21 Truncal injury 20 Truncal injury by 6 Incineration 9 Incineration 5 Submersion the 9 Submersion 5 Hemicorporectomy 3 Hemicorporectomy lin- 600 other reasons 509 otherreasons ges v 6455 Patients assessed for etigibitity ,or 2044 Exctuded (inetigibte)b 2120 Exctuded (inetigibte)b lat 790 Paramedic participating in study 769 Paramedic participatin6 in study f,s- second on scene and airway management atready started second on scene and alrway management already started m. 598 Paramedic participating in study 721 Paramedic participating not first or second on scene in study nd not first or 334 Traumatic injury second on scene 378 Traumatic injury :e- 114 Age <18 y 122 Age <18 y 65 Resuscitation not commenceo or iy 75 Resuscitation not continued by ambulance staff or commenced or tr- res00n0er continued by ambulance staff or 43 Mouthonlyopens<2cm respond€r iy 41 Mouth only opens <2 cm 34 Treated while in the hospitat 3TTreatedwhiteinthehosDital l d- 15 Detained by Her Majesty's prison 5ervlce 27 Detained by Her Majesty's Prison Service l5 Not an out-of-hospitaI cardiac arrest 17 Not an out-of-hospitat cardiac arrest I :h 0 Previousty recruited to triar I Previoustyrecruitedtotrial I I Etigibility status unknown 1 Eligibititystatus unknown. d 4410 Patients enrotted paramedic by 4886 Patients enrolted by paramedic randomized rf randomized to tracheat intubation to supraglottic airway device e

686 EMS ctinician clusters (median Ll 4886 Patients per paramedic, 6 [QR,3-10]; range, 1-56) c :11?::!.,lltt:*ll.d.il.r111v13n.eementattempt i 4161 patientsreceived:lairwaymanas.r.nt*t.rp. 2724 Received tracheat intubation first 4009 n.i.".J itrov,rp"nf.u,i ,ir*rii*n. t,", advanc€d"irwav managem_ent 722 ::: :ld-i:.1 l.:.iy. Did not receive advan-ced airway manasement 523 Received studv supraglottic airway device first rro n.i.iu.,r ti.fru.r;;irbdffi:i 72 Receivednon-studysupraglotticairwaydevicefirst 36 Receivednon-studysupraglotticairwaydevicefirst 6 Received unknown intervention l Received unknown -_r ] intervention r. 4o0l in primarv oltcome patients l1i:l:: analysis 4882 inctuded in primary outcome anarysis 3 Patientsexcludedfromtheprimaryoutcome'..trded. 4-.nrtyrirlraritt.atorpart-i.iprit,igfroipit.f patientsexcludedtromtheprimaryoutcome analysis(admittedtononpirticipaiinghospitaD I I but could not be identified)

Grouped according to the randomization assignment of the first paramedic (interquartile on range [QR]. 3-12; range, l-54) and 6 for SGA (leR, 4-ll; range, the scene who was participating in the studi. 1-31). The median number of trial patients treated by a paramedic who later a 't{O) .l-4; There were 113 paramedics who withdrew after randomization (5g withdrew is 3 for Tl (tQR, l.O-5.5; range, and 2 for SGA (teR, range, randomized to tracheal intubation [Tl] and 55 randomized to the supraglottic l12). These trial patients were retained and included in the analysis. airway device The median patients b [SGA]). number of with out-of.hosoital Patients can have more than I reason. cardiac arrest treated by a paramedic who later withdrew is 7 for Tl

lama.com JAMA August28,2018 Volume32O.Number8 741 Research Original InvestiSation Effects of a Supraglottic Airway Device vs Tracheal Intubation After Out-of-Hospital Cardiac Arrest

block sizes (range,4-8) and stratified by EMS provider organi- ible chest rise and was classified as "yes" when advanced air- zation (4 levels), paramedic experience (2 levels), and distance way management was not used; (2) regurgitation (stomach from the paramedic's base ambulance station to the usual des- contents visible in the mouth or nose) or aspiration (stomach tination hosPital (2 levels). contents visible below the vocal cords or inside a correctly placed tracheal tube or airway channel of a supraglottic air- lntervention way device) and each was classified as "no" when advanced The intervention was the insertion ofa second-generation airway management was not used; (3) any unintended loss of supraglottic airway device with a soft noninflatable cuff (i-gel; a previously established airway (patients with advanced air- Intersurgical)- Because ofits speed and ease ofinsertion, this way management only); (4) sequence of airway interventions device has become the most commonly used supraglottic air- delivered (patients with advanced airway management only); way device during out-of-hospital cardiac arrest in England.r3Ja (5) return of spontaneous circulation (patients with ad- The current standard of care is tracheal intubation using di- vanced airway management only; patients who died at the rect laryngoscopy; video laryngoscopy is not used by para- scene classified as "no" for return ofspontaneous circulation medics in England. at hospital admission); (6) airway management in place when A standard approach to airway management (from basic return ofspontaneous circulation was achieved or resuscita- to advanced techniques) was agreed on by the participating tion was discontinued (patients with advanced airway man- ambulance services. This included the use of bag-mask agement only); (7) chest compression fraction (in a subset of ventilation and simple airway adjuncts prior to advanced patients in 2 EMS provider organizations); and (B) time to death. airway management. Apart from the initial advanced airway High-quality, continuous cardiopulmonary resuscitation management, care proceeded as usual for patients with out- (CPR) is associated with increased survival and improved func- of-hospital cardiac arrest enrolled in the trial All other care tion following out-of-hospital cardiac arrest; the concept of was delivered according to standard international resuscita- compression fraction has been developed to standardize its tion guidelines.3 measurement.lT Therefore, compression fraction was mea- Paramedics received additional training in their allocated sured and compared in a subset of patients treated by 2 am- advanced airway management intervention immediately bulance services using the "CPR Card" (Laerdal), which is a after randomization. Training comprised theoretical and small disposable device placed in the center of the patient's simulation-based practice over t hour with a brief assessment chest during CPR. The device gives no feedback to the para- to confirm competence. For tracheal intubation, a 2-person medic but records data that can be retrieved later. techniqueusingan intubatingbougiewas recommended. End- Data on resource use to support a cost-effectiveness analy- tidal carbon dioxide monitoring was used to confirm correct sis and longer-term function also were collected. These data device placement in all patients. are not reported herein. Protocol deviations could arise because paramedics have both strategies available to them. Usual practice follows a step- Sample Size wise approach from simple to more advanced techniques, but In a previous feasibility study, 9% ofpatients survived to hos- paramedics have the clinical freedom to adapt airway man- pital discharge.18 No data were available for the modified agement during out-of-hospital cardiac arrest to the patient's Rankin Scale score. However, death and poor functional out- anatomy, position, and perceived needs. The trial protocol come after out-of-hospital cardiac arrest are closely related specified 2 attempts using the allocated strategy before pro- because death is the most common outcome.r6 ceeding to the alternative; however, paramedics had discre- An improvement of 2% in the proportion of patients achiev- tion to deviate from the trial protocol on clinical grounds. ing a good outcome (modified Rankin Scale score range, O-3) was Allowing discretion was necessary to avoid a paramedic judged to be clinically important and consistent with the 2.4% feeling obliged to undertake an intervention that he or she be- difference observed inretrospective datale between tracheal in- lieved to be contrary to the patient's best interests. This also tubation and a supraglottic airway device for survival to hos- was necessary to secure approval from the research ethics com- pital discharge. This meant that 9O7O patients in total were mittee and professional support. needed to detect a difference of8% vs l0% at the significanc'e level of 5% with 90% power after allowing for clustering.lr Outcomes The primary outcome was modified Rankin Scale score at Statistical Analysis hospital discharge or at 30 days if the patient remained in the Analysis of the primary outcome and exploratory analyses of hospital. Patients were transported to and followed up at secondary outcomes were performed according to a prespeci- each hospital by assessors blinded to treatment group who f,red statistical analysis plan, which was finalized before data collected the modified Rankin Scale score. The modified lock and any comparative analysis, but after the end ofrecruit- Rankin Scale score is used widely in out-of-hospital cardiac ment due to staff changes within the statistical team. Some arrest research,ls'r6 and is usually divided into 2 ranges: O to 3 typographical errors were corrected in version 2 and some (good outcome) or 4 to 6 (poor outcome to death). points were clarified, but no substantive changes were made. The following secondary outcomes were collected for all No comparative post hoc analyses were performed. eligible patients and all but the last 2 were reportedby the para- The primary analyses included all eligible patients with medics: (1) initial ventilation success. which was defined as vis- outcome data available except for the following secondary

JAMA August28,2O18 Volume320,Number8 Jama.com 'e5I Effects of a Supraglottic Airway Device vs Tracheal Intubation After Out.of.Hospital Cardiac Arrest Original Investigation Research ir- outcomes that only applied to those who received advanced Enrolled patients were transported to 95 hospitals and ch airway management: (1) any unintended loss of a previously followed up to hospital discharge. Follow-up ended in Febru- ch established airway; (2) return ofspontaneous circulation dur- .h, ary 2018. The randomization of paramedics was well bal- ing airway management; and (3) airway management in place anced (759 to the supraglottic airway device group and 764 ll-:- when return of spontaneous circulation was achieved or re- to the tracheal intubation group). There were 113 paramedics ed suscitation was discontinued. Chest compression fraction was who withdrew after randomization (58 randomized to tra- of only measured in a small subset of patients. Patients were cheal intubation and 55 randomized to the supraglottic air- ir- grouped by the allocation ofthe first participating paramedic way device; additional information appears in the eText in NS on the scene (main analyses). The analyses were adjusted for Supplement 2). ,r\ ' stratification factors as fixed effects. There were more patients in the supraglottic airway de- d- For binary outcomes, mixed-effects logistic regression was vice group (n = 4886) than in the tracheal intubation group :IE used to estimate the odds ratios (ORs) for the primary analy- (n = 4410). The proportion of patients with out-of-hospital car- )n sis and paramedic was fitted as a random effect. Risk differ- diac arrest was similar in the 2 groups for attempted resusci- .ln ences and risk ratios also were estimated using generalized tation (7007 of 13 587 patients [51.6%] in the supraglottic air- a- linear regression and standard errors were calculated using way device group vs 6455 of 12789 patients [50.5%] in the n- a sandwich estimator to allow for clustering. The risk ratios are tracheal intubation group) and eligibility (4886 of7O06 pa- of reported in Supplement 2. tients [69.7%] in the supraglottic airway device group vs 44lO h. For time-to-event outcomes, Cox proportional hazards re- of 6454 [68.3%] in the tracheal intubation group). )n gression was used. The proportionality assumption, which was The patient characteristics and cardiac arrest details were c- checked using Schoenfeld residuals, was met. balanced between the groups (Table 1; eTables I and 2 in cf Multiple imputation was not done because the level of Supplement 2). Patients randomized to tracheal intubation ts missing data was only 7 patients (O.08%) for the primary out- were more likely to crossover to the supraglottic airway de- a- come and less than l.5o/o for all but I of the secondary out- vice as a result of a clinical decision made by the paramedic :l- comes, which had missing data for 6.4% of patients. on scene (Figure 2; eTable 3 and eFigure 1 [contains further in- a Two prespecified exploratory subgroup analyses were per- formation regarding return of spontaneous circulation dur- 5 formed for the primary outcome: (l) out-of-hospital cardiac ar- ing or after advanced airway managementl in Supplement 2). 1- rest with a likely cardiac cause that is witnessed and has an ini- tial rhythm amenable to defibrillation (Utstein comparator Primary Outcome group)2o vs a noncomparator group and (2) out-of-hospital car- The primary outcomewas available for 9289 of 9296 patients diac arrest witnessed by a paramedic vs not witnessed by a (99.90/"; Table 2). ln the supraglottic airway device group, 3ll paramedic. The treatment effect in the subgroups was com- of4882 patients (6.4%) had agood outcome (modified Rankin pared by testing for a paramedic randomization x subgloup Scale score range, O-3) vs 3OO of 4407 patients (6.8%) in the variable interaction. tracheal intubation group (adjusted OR, OS2195o/oCl,O.77 to ;- Three prespecified exploratory sensitivity analyses were 1.O91; adjusted risk difference [supraglottic airway device mi- d performed for the primary outcome. The first extended the nus tracheal intubationl, -0.60/0 195% CI, -1.60/o to O.4%l; L- population to include patients treated by a participating para- Figure 3 and eFigure 2 in Supplement 2). d medic butwho were not resuscitated (ie, trial patients plus non- resuscitated patients). This was prompted by feedback from Exploratory Sensitivity and Subgroup Analyses the data and safety monitoring committee on a preplanned for the Primary Outcome ts closed interim analysis of half the sample. Including patients treated by a participating paramedic who /s The second and third sensitivity analyses were planned were not resuscitated did not change the conclusion for the pri- 1- from the outset and were restdcted to the coh,ort ofpatients mary outcome (311 of 11462 patients [2.7n]inthe supraglot- ;- who received advanced airway management. Comparisons tic airway device vs 300 of 10 741 patients [2.8%] in the tracheal e were made as allocated and by the treatment received. intubation group had a good outcome; adjusted OR, 0.96 [95% e A 2-sided significance level of5% was used. The 2 groups CI, O.8l to 1.141; risk differenc e, -O.2% 195% Cl, -O.6V. to O.3o/.J; were compared using Wald tests. No adjustment was made for Figure 3 and eTable 4 in Supplement 2). multiple testing; therefore, the secondary outcomes should be However, of the 7576 (81%) patients who received ad- considered exploratory.2l All analyses were performed using vanced airway management, more patients in the supraglot- Stata version 15.1 (Statacorp). tic airway device group had a good outcome (163 of 4158 pa- tients [3.9%] vs 88 of 3418 patients [2.6%] in the tracheal intubation group; adjusted OR, 1.57 [95% CI, 1.18 to 2.07]; risk difference, l.4o/'L95% CI, O.5% to 2.2%l). Results This effect also was observed in the analysis of patients There were 1523 paramedics who were recruited and random- grouped according to the first type of advanced airway man- ized. Of the 13 462 potentially eligible patients treatedbythe par- agement intervention received (193 of 4630 patients [4.2%] in ticipatingparamedics between June 2015 and August 2017,4166 the supraglottic airway device group vs 58 of 2838 patients (31%) wereexcluded and 9296 (697")wereenrolled (medianage, [2.O%] in the tracheal intubation group; adjusted OR, 2.06 [95%

73 years; 3373 were women [36.3%]; Figure I and Table l). CI, 1. 51 to 2. 8 1l ; risk diffe r ence, 2.l%o 19 5% d, I.2% to 2.90/"1).

tama.com JAMA August28,2O18 Volume32O,NumberS Research Original Investigation Effects ofa SupraSlottic Airway Device vs Tracheal Intubation After Out'of-HosDital Cardiac Arrest

Table l. Patient Demographics and Cardiac Arrest Details

No. of Patients/Total No. (%)" Supragtottic Tracheal Intubation Airway Device (n = 4410) = 4886) Patient Demographics

Sex, No. (%)

Men 2791 (63.3) 3132 (54.1) Women 15r.9 (35.7) 17s4 (3s.9) Age, median (lQR), y 74 (62-83) 73 (61-82) Cardiac Arrest Details

Time, median (lQR), min

From emergency call to first paramedic arrivaI 8 (s-11) 7 (s-11) paramedic From first arrivaI to triat paramedic arrivalb 0 (0-4) 1 (0-4) Presenting rhythm

Asystote 23s614316 (s4.6) 2s971479r (s4.2) Ventricutar f ibriltation 97914316 (22.7) 10941479t (22-8) Pulsetess ventricular tachycardra 4414316 (r.0) 3e/4791 (0.8)

Putseless electrical activity e37 143L6 (2r.7) t06u479r (22.r) Witnessed cardiac arrest 278814407 (63.3) 3101/4883 (63.s) Witnessed by a bystander 2231l2788 (80.0) 2493/3100 (80.4) Witnessed by a paramedic ss712788 (20.0) Gotl3100 (1e.6) Type of bystander or responder action

CPR before paramedic arrival 2774/4406 (63.0) 3149/4883 (64.s) Defibrillation before paramedic arrivat. 146/4390 (3.3) 17614863 (3.6) Return of spontaneous circutation achieved 201146 (r3.7) 271776 (rs.3) At Arrivat of Study Paramedic

Airway management in progress 1384/4389 (31.s) 1463/4863 (30.1) Type of airway management Ba9-mask ventilation onty 27311383 (r9.7) 307/1463 (2 1.0) 0ropharyngeal airwayand bag-mask ventitation 766/1383 (ss.4) 87sl1463 (s9.8) Abbreviations: CPR, cardiopulmonary

Nasopharyngealairway and bag-mask ventilation 1 1/1383 (0.8) 1U1463 (0.8) resuscitation; lQR, interquartile range. a Triat supraglottic airway device 26211383 (18.9) 190/1463 (13.0) Unless otherwise indicated. Patients are grouped by the randomization Intubation 3/1383 (0.2) 3/1463 (0.2) assignment ofthe first study Other supraglottic airway device 44l1383 (3.2) s7 /1463 (3.9) paramedic on the scene. bThere Mouth-to-mouth resuscitation 8/13s3 (0.6) 10/1463 (0.7) were missing data for3 pocket patients randomized Face shie[d or mask 5/1383 (0.4) 411463 (O.3) to tracheal intubation and 1 patient randomized Suction 3i 1383 (0,2) (0.1) 2/1463 to the study supraglottic Other 8/1383 (0.6) 4/1463 (0.3) airway device. 0ngoing successful ventilation 1 1 10i 1372 (80.9) r1si,4lr45s (7s.3) ' This was achieved using an automated external defi brillator Return of spontaneous circulation 300/4393 (6.8) 32814862 (6.8) available at the scene.

There was no interaction between randomization group Two of the secondary outcomes (regurgitation and and either subgroup (Figure 3; Utstein comparator group aspiration) were not significantly different between groups p vs Utstein noncomparator group, = .24; out-of-hospital when all instances occurring before, during, or after ad- cardiac arrest witnessed by a paramedic vs not witnessed by vanced airway management were combined. Regurgitation aparamedic, P=.24. occurred among 1268 of 4865 patients (26,10/") in the supra- Slottic airway device group compared with lO72 of 4372 Secondary Outcomes patients (24.50/') in the tracheal intubation group (adjusted The secondary outcomes appear in Table 2 and in eTable 5 in OR, LO8 l95o/o Cl, 0.96 to 1.2O1; adjusted risk difference, Supplement 2. The supraglottic airway device treatment 1.4% [95% Cl, -0.6% to 3.4%]). Aspiration occurred among strategy was significantly more successful in achieving venti- 729 of 4824 patients (15.1%) in the supraglottic airway Iation after up to 2 attempts (4255 of 486g patients t}7.4%l device group compared with 647 of 4337 patients (I4.9%) in vs 3473 of 4397 patients 179.O"/o) with tracheal intubation; the tracheal intubation group (adjusted OR, l.Ol [95% CI, adjusted OR, 1.92 195% Ct,1.66 to 2.221; risk difference, 2.1% O.B8 to 1.161; adjusted risk difference, O.lo/o [95% g, -1.5% [95% U,l.zYoto2.9%]). ro 1.8%l).

7A4 JAMA August28,2Ol8 Volume32O, Number8 Jama.com 3 Figure 2. Patient P Interventions and Outcomes bV fri

3 6 f-- 9296 -t a Patients in trial o - g ylo (!7 .1%) Treated by param_edic i , randomized 4ggj6 (52.6"/")rrcated bi paramedic d j to tracheal intubation; mRS scor., randomized q_ i ti supragtottic airway device; mRS score: 1 30014407 (6.8%) in 0_3 ranse i a I i iirlagsz t6.4%) in o-3 ranee

) ili:i,ffiif;i.3ff]';,:;:"'* ii 1:t:,:tytrs:6%,i,a.;,lis"448714882(er.e%) :ur[r.*r,iirir.",r.",." Ii Dieda ? ji __ 4UnknownmRSscore g 409314393 (93.2%) No return of spontaneous crrcuEtton when study paramedic arriveda; mRS sCOre: B returnof spontaneous "'v J'orreE , circulationwhenstudyparamedicarriveda,rRsraora,:l::i{1,::?.,(h?:r*o 38551409t (94.2%)i in 4-6v range I -z!' 'r' - 'o"ec 22414530(4.9%) 3801/4091 (92.9%) - in 0-3 ranoe Diedb ) tffiffi;;;;.[''" I 43-06t4s30(es.i%)in4-6ringe d 5 i ] 4 Unknown mRS score c --.- -v.. | 90814090(22.2%) 3 . v !o__a!y11ce{girryy iiliifrt:i,.liiil- ii i?:{1ffi13,?llll;l*lJx."#el':.:':;;;m if- maragementa;mRSscore,trrdnagement";mR5score: i] managementa,cjmRSsrmanagementa,c;mRsscoret sscore: ','t'e.1G32")R.i;il;,p.,t;;;;;,;i,. t*lou',rr'nra ol* |11ry1-a,sg191t"1';'mnsscore, 642ss(20.7%)ino-3ranse il f:l-'lilrr*meoicarrived{mni-ior'"'ulation ]l r63/e06163/906 (18.0%) in 0-3 p.z"tl3%) in o_? ] lli:.tLt"t';,t;:;' JI tilzrsz(2.2"/.)ino-zttlz'3z73t3ta2O ino_z ,'r1rn1,t3%)in4-6ranqe il ii i1i11::11:1")l:"r;l::::^' il l,',/'TffiJ;1,xi:T"'ft!i.;-,id!i:'r-Rsscore, I $H:;:l'.:,13,''##,.,,., el 7-431906 (82.0%) in 4-6 rl 3rosl3rs2 (97.7%)in 'i ,.i '- ,,ill u'r ffifflii;:;ilffi;.'jttr.n*1'n il i ffi?,;;;;;,;, 'i ::;it:zilyzr227t328(6s.2%) '.+ii'is'Diedt ^, 'n range ; li i:ii-\i:!jil'il;z'**I Unknown mRS score l,ont/.utt , 4_6 range ft'Jfi;yffi1J;:." i!!: _" , +l 7151906(78.9%)Diartt L5I.eu6 \t4.9%) Oiedoli 3083/3182 (96.9%) r Disdb i 4-6 range i 4-6 Dnno. 2UnknownmRSscore I .r$tl^r!-,:OUnknownmRsscore ll=l-._-_l l sl -.., , llunknownmRsscore lunknownmnsscore-' i,--. ------l I i -- ]i ,r;nnnz

Table 2. Primary Outcome, Survival Status, and Main Secondary Outcomes o = o No. of Patients/Totat No. (%)a c m Supragtottic Tracheal lntubation Airway Device Adjusted Estimate f. N Adjusted Risk Difference (n 4410) (n (95%CDb = = 4886) P Value' Estimate (95% Cl), %b P Value' ;! = Primary 0utcome: Modified Rankin Scale Score at HospitaI Discharge or 30 d =l @ 0-3 range (good outcome) 30014407 (6.8) 311,14882 (6.4) (0.77 o 0R,0.92 to 1.09) .33 -0.6 (-1.5 to 0.4) t. o 0 (no symptoms) 12414407 (2.8) (2.4) rr7 14882 1. 3 o I 4814407 (r.D 41/4882 (0.8) 2 s0/4407 (1.1) s8/4882 (1.2) 3 7814407 (1.8) 9sl4882 (1.9) q3 o 4-5 range (poor outcome to death) 4107 14407 (93.2) 457r14882 (93.6) 4614407 (r.0) 4s14882 (o.e) 5 2714407 (0.6) 39/4882 (0.8) 5 (died) 403414407 (9r.s) 448714882 (9L.9) Secondary Outcomes

SurvivaI status m Died at scene 248814407 (s6.5) 262314882 (s3.7) Died prior to ICU admission 10s814407 (24.0) 122614882 (25.r) prior Died to ICU discharge 36s14407 (8.4) s03/4882 (10.3) c ! Died prior to hospitat discharge 72014407 (2.7) (2.8) 138/4882 q9- Survived to 30 d or hospital discharge 37214407 (8.4) 392/4882 (8.0) -. Time to death € No. of patientsd 4400 4871

Median (lQR), min 63 (41 to 216) 67 (4r to 267) HR,0.97 (0.93 to 1.02) .22 o s. Time to death was 0-72 h o

No. of patientsd 4400 4871 [Iedian (lQR), min 53 (a1 to 20s) 67 (41 (0.92 ro 246) HR,0.96 to 1.00) .07 o 72-h Survival s7sl439s (13.1) 66414872 (L3.5) OR, 1.04 (0.92 to 1.18) .54 0.02 0.4 (-1.0 to 1.9) .54 l lhitiaI ventitation success (s2 attempts at advanced 347314397 (79.0) 42ss14868 (87.4) OR, 1.92 (1.66 to 2.22) <.001 0.12 8.3 (5.3 to 10.2) <.001 q airway management) a. Tracheal intubation 1891/2723 (69.4) 92lLr6 (7e.3) TriaI supraglottic airway device s42l6L7 (87.8) 3412/3994 (8s.4) o 0ther supragtottic airway device ssl72 (76.4) 2el36 (80.6) o Any unintended [oss of a previousty established airway" 1s3/3081 (5.0) 412l3900 (10.6) OR,2.29 (1.86 to 2.82) <.001 s.9 (4.6 to 7.2) r Tracheal intubation 7012149 (3.3) 33/s70 (s.8) TriaI supraglottic airway device 84/e81 (8.5) 389/345s (11.3) 9r-' al Other supraglottic airway device slrTt (2.9) 3/33 (e.1) o 3 ia (continued) 3 o

-.Gd E' m 3 Table 2. Primary Outcome, Survival Status, and Main Secondary Outcomes (continued) P o

3 No. of Patients/Totat No. (%)a Supraglottic C Tracheal Intubation Airway Device Adjusted Estimate Adjusted Risk Difference ! (n a410) (n 4885) (95% = = Ct)b P Value' Estimate (95% ct), %b P Valuec E Regurgitation at any time 107214372 (24.s) 1268/486s (26.1) OR, 1.08 (0.96 1.20) to .21 0.06 1.4 (-0.6 to 3.4) 77 c. Aspiration at any time 647 /4337 (r4.9) 72914824 (7s.7) OR, 1.01 (0.88 to 1.16) .84 0.08 0.1 (-1.s to 1.8) 86 > Initiat attempi with supragtottic airway device o€ or tracheaI intubation o o Regurgitation befote 92314379 (2r.r) (r7.4) 84614869 6' o Aspiration before s89/43ss (13.s) 532/4840 (11.0) Regurgitation during or after s43l4351 (12.s) 87sl4857 (18.0) J Aspiration during or after 30414344 (7.0) 473l482e (9.8) o 9a Admitted to ED or hospitat 192214410 (43.6) 226314886 (46.3) q Return of spontaneous circulation 124914404 (28.4) 149sl4880 (30.6) 0R, 1.12 (1.02 to 1.23) 2.2 (0.3 to 4.2) at arrival to ED or hospital o' f Survived to ED discharge 861/1919 (44.9) ro33l22s9 (45.7) @ Abbreviations: ED, emergency department; HR, hazard ratio; lCC, intracluster correlation coefficient; usual hospital and stratified by emergency medical services provider organization and standard errors adjusted c lCU, intensive care unit; lQR, interquartile range; OR. odds ratio. for clustering. o a Unless otherwise indicated. Patients are grouped by the randomization assignment ofthe first study paramedic c The Wald test was used to make comparisons. on the scene. o o Patients who survived to ICU discharge but did not consent to active or passive follow-up were censored at ICU oThe !. ORs and risk differences were adjusted for stratification factors fitted as fixed effects. The ORs were discharge because research approvals did not permit analysis of subsequent data apart from the modified 9l obtained from a mixed-effects logistic regression model with study paramedic fitted as a random effect. Rankin Scale score. Risk differences were obtained by fitting a generalized linear model (binomial family and identity link) and 'Had at least 1 advanced airway management attempt. 6' standard errors adjusted for clustering. The HRs were adjusted for paramedic experience and distance from o

= q9

N ; q9.=. f O 9l o o 3- o m go N o f c o q3 o o@ Research Original Investigation Effects ofa Supraglottic Airway Device vs Tracheal Intubation After out-of-Hospital Cardiac Arrest

Figure 3. Forest Plot of Primary and Subgroup Analyses

No. of Patients/Total No.a Favors: Favors Tracheal Supraglottic Adjusted odds Tracheal : Supraglottic Intubation AirwayDevice Ratio (9s% Cl) Intubation AirwayDevice P Vatle Primary analysis for modified Rankin Scale scoreb 30014407 377/4882 0.92 (0.77-1.09) .5J Subgroup analysis --f-

Utstein comparatorc ts4l697 r771764 1.04 (0.80_1.3s) i. .24d Utstein noncomparatorc 130/36s8 123/4067 0.84 (0.6s-1.09) _f-- 0ut-of-hospitat cardiac arrest witnessed by paramedice 871s56 76/607 0.78 (0.55_1.09) 0ut-of:hospitat cardiac .24d arrest not witnessed by paramedice 2r2/3848 23s14277 0.98 (0.80_1.20) -+- Sensitivity anatysis for primary outcomef 30011074t 31L/77462 0.96(0.81-1.14) -_|- .D5

1.0 Odds Ratio (95% Cl)

The area ofthe squares is proportional to the number of patients included. arrest with a likely cardiac cause that is witnessed and has an initial rhythm The odds ratios were estimated from a mixed-effects logistic regression model amenable to defibrillation. For the utstein comparator and noncompararor with stratification factors fitted as fixed effects and study paramedic as a analyses, there were missing data for lo3 patients (52 in the tracheal random effect. The Wald test was used for the pvalue patients comparisons. intubation group and 51 in the supraglottic airway device group). are grouped by the randomization assignment ofthe first study paramedic on d Indicates a Pvalue for interaction. the scene. A breakdown ofthe modified Rankin Scale scores in the form of horizontally stacked bar charts appears in eFigure 2 in Supplement 2. "The not witnessed group includes all arrests not witnessed by a stuoy paramedic. a patients For the witnessed and not witnessed analyses, there were missing No. of with a modified Rankin Scale score in the range ofO to 3 data for 7 patients (3 (good outcome). in the tracheal intubation group and 4 in the supraglottic bThere ainaay device group). were missing data for 7 patients (3 in the tracheal intubation group r Includes patients treated by a study paramedic and 4 in the supraglottic airway device group). who were not resuscitated. There were c missing data for4 patients (l in the tracheal intubation group and 3 The Utstein comparator includes patients with an out-of.hosDital cardiac in the supraglottic airway device group).

The median time to death was not significantly different Paramedics randomized to use tracheal intubation were between the groups (67 minutes for the supraglottic airway less likely to use advanced airway management than para- device in 4871 patients vs 63 minutes for tracheal intubation medics randomized to use the supraglottic airway device, in 44OO patients), and neither was the compression fraction Tracheal intubation is a more complex skill than supraglottic in a very small sample patients (median g6% of 66 of linter- airway device insertion and requires 2 practitioners, addi- quartile range, 8l%-9lo/olin34 patients for the supraglottic tional equipment, and good access to the patient,s airway24; airway device vs median of 83o/o [interquartile range, T4yo- however, out-of-hospital cardiac arrest often occurs in loca- 89%l in 32 patients for tracheal intubation (p = .14; eTable 6 tions where patient access is challenging. in Supplement 2). Tracheal intubation has been associated with potential harms including unrecognized esophageal intubation, lengthy E pauses in chest compressions, and overventilation.2s,26 No evi- Discussion dence of a difference in compression fraction was found in a small subsample of the enrolled patients, but the potential for In this pragmatic, multicenter, cluster RCT, no significant dif- harm associated with tracheal intubation persists. ference was found between tracheal intubation and the su- At the outset, it was expected that most patients with a fa- praglottic airway device for the primary outcome of modified vorable outcome would not receive advanced airway manage- Rankin Scale score (range, O-3; good outcome) at hospital dis- ment, and that some crossover would occur. For these rea- charge or 3O days after an out-of-hospital cardiac arrest for all sons, 2 exploratory sensitivity analyses were prespecified only trial patients. in patients who received advanced airwaymanagement, even Patients with a short duration of cardiac arrest and who though these analyses are susceptible to bias.27 receive bystander resuscitation, defibrillation, or both, are Patients who received advanced airway management considerably more likely to survive and are also less likely to were similar in the 2 groups (eTable I and eTable 2 in Supplement require advanced airway management.22 This problem of 2), and a strategy of using a supraglottic airway device first confounding by indication is an important limitation of was associated with better outcomes whenever advanced many large observational studies that show an association airway management was undertaken by a trial paramedic between advanced airway management and poor outcome (eTable 4); however, the between-group difference was less in out-of-hospital cardiac arrest.23 This study found that than the prespecified clinically important difference and less 2l.l% (36011704) of patients who did not receive advanced than the minimally important difference of approximately airway management achieved a good outcome compared 3% reported by others.28 with 3.3% (25U7576) of patients who received advanced air- The strategy ofusing a supraglottic airway device first also way management. achieved initial ventilation success more often. Although

JAMA August28,2Ol8 Volume32O.Number8 Jama.com L| |

regurgitation and aspiration occurred with similar frequency alrway management, and the use of advanced airway man- overall, regurgitation and aspiration during or after advanced agement was greater among paramedics in the supraglottic airway management were significantly more common in the airway device group compared with those in the trac- supraglottic airway device group. Conversely, patients in the heal intubation group, which could result in confounding tracheal intubation group were significantly more likely to re- by indication.32 gurgitate and aspirate before advanced airway management, Second, there was an imbalance in the number of pa- possibly due to less frequent use of advanced techniques to tients in the 2 groups, probably due to unequal distribution of secure the airway in this group and the increased time re_ a small number of paramedics who recruited considerably more quired for tracheal intubation compared with insertion of patients than the average; however, it was not possible to a supraglottic airway device. stratify for this because these individuals could not be iden- A recent RCT ofFrench and Belgian patients with out-of- tified in advance. hospital cardiac Eurest that compared bag-mask ventilation with Third, there was crossoverbetween groups, which was in- tracheal intubation delivered by physicians as part ofan EMS evitable on practical and ethical grounds. team proved inconclusive.2e To our knowledge, no RCT has Fourth, although other elements of care (eg, initial basic air- compared bag-mask ventilation with a supraglottic airway de_ way management and subsequent on-scene and in-hospital vice in patients with out-of-hospital cardiac arrest. care, such as targeted temperature management and access Reported rates ofventilation and tracheal intubation suc- to angiography) followed established guidelines, between- cess have been higher in previous studies2e-31; however, these group differences in these factors could have influenced rates were based on selected populations and practitioners with the findings. greater training and experience, including physicians. The cur_ Fifth, the participating paramedics were volunteers, and rent study reflects both the reality paramedic ofcurrent prac- their airway skills maynotbe representative ofthose who chose tice in England, and the challenges of airway managernent in not to participate in the study. a patient group for which regurgitation and poor airway ac- Sixth, the findings are applicable to use of the particular cess are common. supraglottic airway device in countries with similar EMS pro- Any unintended loss previously of a established airway oc- vision to England where paramedics treat most patients with curred twice as frequently in the supraglottic airway device out-of-hospital cardiac arrest. The findings may not be ap- group than in the tracheal intubation group. There are some plicable in countries with physician-led EMS provision or patients with cardiac arrest for whom effective ventilation can- to another supraglottic airway device that may have differ- notbe achieved withbasic airway management techniques or ent characteristics. However, the principles underpinning with a supraglottic airway device, and for whom tracheal in- the insertion and function of all supraglottic airway devices tubation may be the only way of achieving effective ventila- are similar. tion. The exact role of different advanced airway manage- ment techniques in adults with out-of-hospital cardiac arrest, and the associated implications for skill acquisition and main- tenance, remain to be determined. Conclusions Among patients with out-of-hospital cardiac arrest, random- Limitations ization to a strategy of advanced airway management with a This study has several limitations. First, the trial population supraglottic airway device compared with tracheal intuba- included patients who did and did not receive advanced tion did not result in a favorable functional outcome at 30 davs.

ARTICLE INFORMATION Hospitals Bristol NHS Foundation Trust. Bristol, Obtoined funding: Benger, Black, Reeves, Robinson, (Thomas). Accepted for Publication: July 30, 2O18. England Voss, Wordsworth, Rogers. Administrotive, technicol, or moteriol support: Black, AuthorAffiliations: University of the West of Author Contributions: Drs Benger and Rogers had Clout, Nolan, Robinson, Taylor, Thomas, Voss, England. Glenside Campus, Bristol (Benger, Kirby, full access to all ofthe data in the study and take Rogers. Voss); South Western Ambulance Service NHS responsibility for the integrity ofthe data and the Supervrsion: Benget Black. Brett, South. Voss. Foundation Trust, Exeter, England (Kirby, Black, accuracy ofthe data analysis. Wordsworth, Rogers. Robinson, South); Department of Surgery and Concept ond design: Benger, Black, Brett. Nolan, Canceq lmperial College Healthcare NHS Trust. Reeves, Robinson, South, Stokes, Thomas, Conflict of Interest Disclosures: The authors have London, England (Brett); Clinical Trials and Voss, Rogers. completed and submitted the ICMJE Form for Evaluation Unit, Bristol Trials Centre, Bristol Medical Acquisition, onolysis, or interpretotion of dota: Disclosure of Potential Conflicts of Interest. School, University of Bristol, Bristol, England (Clout, Benger, Kirby, Brett, Clout, Lazaroo, Nolan. Reeves, Dr Nolan reported being the editor-in-chiefof Lazaroo, Reeves, Scott, Smartt. Taylor, Rogers); Scoft, Smartt, Stokes, Taylor, Thomas. Voss, Resuscitotion for which he receives honoraria. Bristol Medical School, University of Bristol, Bristol, Wordsworth, Rogers. Dr Reeves reported salary support from grants England (Nolan, Taylor); Department of Drofting of the monuscript: BengeL Kirby, Lazaroo, from the National Institute for Health Research. Anaesthesia, Royal United Hospital, Bath. England Voss. Rogers. Dr Rogers reported salary support from a British (Nolan); CLAHRC West, Whitefriars. Bristol, England Criticol revision of the monuscript for importont Heart Foundation grant until March 2Ol7 No other (Scott); Health Economics Research Centre. intellectuol contenti Benger, Black. Brett. Clout. disclosures were reported. Nuffield Department of Population Health, Lazaroo, Nolan, Reeves, Robinson, Scott, Funding/Support: The trial was funded by the University of Oxford, Oxford, England (Stokes, Smartt. South, Stokes, Taylor, Thomas, Voss, National Institute for Health Research (NIHR) Wordsworth); Intensive Wordsworth, Rogers. Care Unit. Universitv Health Technology Assessment programme Stotisticol onolysisi Lazaroo, Scott, Smartt, Rogers. (project No. l2l157102), and supported by the iama.com JAMA August28,20'18 Volume320.Number8 789 Research Original Investigation Effects of a Supraglottic Airway Device vs Tracheal Intubation After Out-of-Hospital Cardiac Arrest

NIHR Comprehensive Research Networks. ambulance service principal investigator 2Ol3:19(3):181-187 doi:1O.'lO97MCC The study was not funded by any commercial (no compensation was received); Lisa Grimmer, .ObOl3e32836Oac5e manufacturer. BSc, and Katie Sweet, BSc (Hons) (University organization or equipment 6. Hasegawa K. Hiraide A. Chang Y Brown DFM. performed in Hospitals Bristol NHS Foundation Trust, Eristol), This study was designed and Association of prehospital advanced airway Trials and Evaluation and Rosalyn Squire, BSc (University Hospitals collaboration with the Clinical management with neurologic outcome and survival Collaboration- Plymouth NHS Trust. Plymouth), regional research Unit. a UK Clinical Research in patients with out-of-hospital cardiac afiest. JAMA. unit which, as part nurses in southwestern region registered clinical trials ofthe and coordinated and 2013;3O9(3):257-266.doi:lOJOOl/jama.2012.187612 Bristol Trials Centre. is in receipt of NIHR clinical supported data collection for participating study 7. Fouche PF, Simpson PM. Bendall J, Thomas RE, trials unit suPPort funding. hospitals (funded by the NIHR grant); Prematie Cone DC. Doi Airways in out-of-hospital cardiac Andreou, BSc (Hons) (University Hospitals of SA. Role ofthe Funder/Sponsor; The funders had meta-analysis. Leicester NHS Trust. Leicester). and Lucy Ryan, arrest: systematic review and no role in the design and conduct of the study; :244-256. doi:lO MNursci (Nottingham University Hospitals NHs Prehosp Emerg Core. 2014;18(2) collection, mapagement, analysis, and Nottingham), research .3r09n0903r2720r3.83rsO9 interpretation of the data; preparation, review. Trust, regional nurses in East Midlands region and coordinated and 8. Kurola J, Harve H, Kettunen T, et al. Airway or approval of the manuscript; and decision to supported data for participating management in cardiac arrest-comparison of the submit the manuscript for publication. collection study hospitals (funded by the NIHR grant); Sara Jones, laryngeal tube. tracheal intubation and bag-valve Disclaimer: The views and opinions expressed in BSc (Hons) (Cambridge University Hospitals NHS mask ventilation in emergency medical training. this reDort are those of the authors and do not Foundation Trust, Cambridge), regional research Res u scitotion. 2OO4;61 (2):149153. doi :1 01O16/j necessarily reflect those ofthe Health Technology nurse in eastern region and coordinated and .resuscitation.2O04.O'l.Ol4 Assessment Programme, the NIHR, National supported data collection for participating study T, Howes B. Supraglottic airway devices: Health Service, or the Department of Health 9. Cook hospitals (funded by the NIHR grant); Helen Foot, recent advances. Co ntin Educ Anoesth Crit Core Poin. and Social Care. (Hons) (Sheffield Teaching Hospitals BA NHS 201111(2):56-61. doi:1OJO93/bjaceaccpimkqO58 Additional Contributions; We acknowledge the Foundation Trust, Sheffield), regional research 10. D. JA, et al; ROC following persons for their contributions: Megan nurse in Yorkshire region and coordinated and Wang HE, Szydlo Stouffer Investigators. Endotracheal intubation versus Rhys, BSc (Hons) (South Western Ambulance supported data collection for participating study supraglottic airway insertion in out-of-hospital Service NHS Foundation Trust, Exeter), the lead hospitals (funded by the NIHR grant); Simon Gates, cardiac arrest. Resuscitotion. 2012;83(9):10611066. research paramedic in the feasibility study, PhD (University of Birmingham, Birmingham), doi:1O.1016/j.resuscitation.2012.O5.018 supported paramedic engagement, and provided trial steering committee chair and independent expertise when developing the protocol (no member, Charles Deakin. MD (University of 11. Taylor J, Black 5, J Brett S, et al. Design and compensation was received); Rachel Brophy, M5c, Southampton, Southempton), Gavin D. Perkins. MD imDlementation of the AIRWAYS-2 trial: Jenny Lamb, BA (Hons). and Abby Willcox. PhD (University of Warwick, Coventry), and Jasmeet a multi-centre cluster randomised controlled trial of (ClinicalTrials and Evaluation Unit, Bristol Medical Soar, FRCA (Southmead HosDital, North Bristol the clinical and cost effectiveness ofthe i-gel School, University of Bristol). assistant clinical trial NHS Trust, Bristol), independent members. and supraglottic airway device versus tracheal coordinators and managed patient follow-up Keith Douglas and Margaret Douglas. patient intubation in the initial airway management of out (no compensation was received): Adam Wallis, Tom representatives and independent members of of hospital cardiac arrest. Resuscitotion. 2O16; Hill, MA, and Tony West, AAT (South Western the trial steering committee (each received 1O9:25-32. doi:'lOl016/j.resuscitation.2016.O9.015 Ambulance Service NHS Foundation Trust, Exeter), reimbursement of travel expenses incurred during 12. Joint Royal Colleges Ambulance Liaison provided financial management (no compensation attendance at oversight meetings); Gordon Taylor. Committee. C/inrtol Proctke Guidelines; 2016. London, was received); Jonathan Green, MRes (South DPhil (University of Exeter Medical School. Exeter), England: Class Publishing 2O'16. Western Ambulance Service NHS Foundation Trust, data and safety monitoring committee chair and 13. Duckett J, Fell P, Han K, Kimber C, Taylor C. Exeter), Helen Hall, MCoP (East of England independent member, Richard Lyon, MD (NHS Introduction of the l-gel supraglottic airway device Ambulance Service NHS Trust, Melbourn), Richard Lothian, Edinburgh), Andrew Newton, PhD (College for prehospital airway management in a UK Pilbery, MSc (Yorkshire Ambulance Service NHS of Paramedics, Bridgwater). Tom Quinn. MPhil ambulance service . Emerg Med J.2014;31(6):505- Trust, Wakefield), and Gregory Adam Whitley, MSc (Kingston University and 5t George s, University of 5O7. do i t 0. 1 1 36/em er med'2012'202126 (East Midlands Ambulance Service NHS Trust. London, London), and Helen Snooks, PhD (Swansea Nottingham), research paramedics for each University. Swansea), independent members of the 14. Hdske D, Schempf B, Gaier G, Niederberger C. respective institution. delivered regional paramedic data and safety monitoring committee (each Performance of the i-gel'" during pre-hospital recruitment and training, patient screening, and received reimbursement of travel exDenses cardiopuf monary resuscitation. Resuscitotion. 2O13r data collection (funded by the NIHR grant): Theresa incurred during attendance at oversight meetings). 84(9) :1229 -1232. doi :l 0.1O1 6/j. resuscitation Foster, BSc (Hons) (East of England Ambulance .2013.04.025 NHS Trust, Melbourn). research manager REFERENCES Service 15. Whitehead L. Perkins GD. Clarey A, Haywood and provided research support and governance l. Hawkes C, Booth S. Ji c, et al; oHcAo KL. A systematic review ofthe outcomes reported (no compensation was received); Jane Shewan, Collaborators. Epidemiology and outcomesfrom in cardiac arrest clinical trialsi the need for a core (Yorkshire MSc Ambulance Service NHS Trust, ouLof-hospital cardiac arrests in England. outcome set. Resuscitation. 2015;88:l5Ol57 Wakefield), head ofresearch provided research and Resuscitotion. 2O17l lO: 133-14O. doilOlOl6/j doi:lO.lO16/j.resuscitation.2Ol4l1.Ol3 governance (no support and compensation was .resuscltation.2Ol6lO.O3O 16. Rittenberger JC, Raina K, Holm MB, Kim YJ, received); Anne Spaight. MA (East Midlands 2. Jentzer JC, Clements CM, Wright RS, White RD, Callaway CW Association between cerebral Ambulance Service NHS Trust, Nottingham), head Jaffe AS. lmproving survival from cardiac arrest: performance category, modified Rankin Scale. of clinical governance, audit, and research for this a review ofcontemporary practice and challenges. and discharge disposition after cardiac arrest. institution and provided research support and Emerg Med. 2Ol6;68(6):678-689. doi:10 Resuscitotion. 2O1l;82(8):1035-lO4O. doi:1O.1O15 governance (no compensation was received); Ann .1 Ol 6/j.annemergmed.2O16.O5.O22 Marcus Bailey. BSc (Hons) (East of England /J.resuscitation.2Oll.03.O34 Ambulance Service NHS Trust, Melbourn), 3. Monsieurs KG, Nolan JP. Bossaert LL, et al; ERC 17. Christenson J, Andrusiek D. Everson-Stewart S, paramedic consultant for this institution and acted Guidelines 2015 Writing Group. European et al: Resuscitation Outcomes Consortium as ambulance service principal investigator Resuscitation Council guidelines for resuscitation Investigators. Chest compression fraction (no compensation was received); Steven Dykes, MB 2Ol5: section 1: executive summary Resuscitotion. determines survival in patients with out-of-hospital ChB (Yorkshire Ambulance Service NHS Trust, 2O15;951-8O. doi:lOlOl6/j.resuscitation.2Ol5.07038 ventricular fibrillation. Circulotion. 2009120(13): Wakefield), deputy for 1241-1247. doi:lO )161iCIRCULATIONAHAJ09.852202 this 4. Gwinnutt CL. Should we intubate oatients institution and acted as ambulance service principal during cardiopulmonary resuscitation? BMJ. 2017 : 18. Benger J, Coates D, Davies S, et al. Randomised investigator (no compensation was received); 357 )17 7 2. d oi :1O.1136 | bn'j.j17 7 2 comparison of the effectiveness of the laryngeal A. Niroshan Siriwardena, PhD (East Midlands mask airway supreme, i-gel and current practice in J, Nolan JP. management in Ambulance Service NHS Trust, Nottingham). 5- Soar Airway the initial airway management of out of hospital cardiopulmonary resuscitation. Cur Opin Crit Core. research lead forthis institution and acted as

790 JAMA August28,2018 Volume32O,Number8 Jama.com cardiac arrest: a feasibility study. Br J Anoesth. out-of-hospital cardiacafiesl? Ann Emerg Med. necessary to change practice? results of an 2016;116(21:262'268. 2Ol4;64(2):163-154. doi:lO.lOl6/j.annemergmed international survey. Resuscitotion. 2Ol6l07:115.120. .2013.12.OO3 doi:lO.lOl6/j.resuscitation.2Ol6.O8.O04 19. Shin SD. Ahn l(O, Song K..1, Park CB, Lee EJ. Out-of-hospital airway management and cardiac 24. Higgs A, Mccrath BA. Goddard C, et al: Difficult 29. Jabre P, Penaloza A, Pinero D. et al. Effect of

I arrest outcomes: a propensity score matched Airway Society; Intensive Care Society: Faculty of bag-mask ventilation vs endotracheal intubation analysis. Resuscitotlon. 20l2;83(3):3'13-3]9. doi:lO Intensive Care Medicine; Royal College of during cardiopulmonary resuscitation on ,_ .lOl6/j.resuscitation.2Oll.l0.O28 Anaesthetists. Guidelines for the management of neurological outcome after out-of-hospital tracheaf intubation in critically ill adults. Br J Anoesth. cardiorespiratory arrest: a randomized clinical trial. 20. Perkins GD. Jacobs lG, Nadkarni VM. et al: 201812O(2):323-352. doi:1O.1015/j.bja.2Ol7lO.O2l JAMA. 2O'18;319(8):779-787 doi :1O.lOO1/jama Utstein Collaborators. Cardiac arrest and .20r8.0r56 cardiopulmonary resuscitatjon outcome reports: 25. Wang HE, Simeone SJ. Weaver MD. Callaway CW. update of the Utstein Resuscitation Registry Interruptions in cardiopulmonary resuscitation 30. Hubble MW. Brown L. Wilfong DA, Hertelendy Templates for out-of-hospital cardiac arrest. from paramedic endotracheal intubation. Ann A, Benner RW Richards ME. A meta-analysis of Resuscitotion. 2015;96:328'34O. doi:l0.lOl6/j Energ Med. 2OO9;54(5):645-652.el. doi: lO.lOl6/j prehospital airway control techniques part l: .resuscitation.20l4.ll.oo2 .annemergmed.2OO9.O5.O24 orotracheal and nasotracheal intubation success rates. Prehosp Eme rg Core. 2O1O;14(3) :377 -4O1. 21. Schulz KF, Grimes DA. Multiplicity in 25. Kramer-Johansen J, Wik L. Steen PA. Advanced doi:lO.3lO9/1090312100379O173 randomised trials l: endpoints and treatments. cardiac life support before and after tracheal Loncet. 2OO5;365(947O):1591-1595. doi:lO.lO16 intubation-direct measurements of quality. 31. Dyson K, Bray JE, Smith K, et al. Paramedic /s0140-6736(O5)66461 -6 Resuscitotion. 2006;68('l):51-69. doi:lO.l0l6/j intubation experience is associated with successful .resuscitation.2005.o5.o20 tube Dlacement but not cardiac arrest survival. Ann 22. Andersen LW, Grossestreuer AV Donnino MW. Emerg Med. 2Ol7;7O(3):382-390.e1. doi:lOJOl6/j Resuscitation time bias-a unique challenge for 27. Swanson SA, Robins -JM. Miller M, Hern6n MA. .annemergmed.2o17.O2.OO2 observationaf cardiac arrest research . Resuscitotion. Selecting on treatment: a pervasive form of bias in 2018;'125:79-82. doi:lO.lOl6/j.resuscitation instrumental variable analyses.,4m J Epidemiol. 32. Kyriacou DN, Lewis RJ. Confounding by .2018.o2.0o6 2015J81(3):191-197 doi:1OJ093/aje/kwu284 indication in clinical research. JAMA. 2016;316(17): 1818-1819. doi:lO.lOOl/jama.2016.16435 23. Carlson JN, Reynolds JC. Does advanced airway 28. NicholG. Brown SP, Perkins GD, et al. What management improve outcomes in adult change in outcomes after cardiac arrest is

JAMA August28.2Ol8 Volume320,Number8 791 Jama.com

September 5, 2018

Governor Charles Baker Massachusetts State House 24 Beacon Street Room 280 Boston, MA 02133 Attention: Governor’s Office

Dear Governor Baker;

The Lowell Board of Health joins over 70 other Local Health Boards across the Commonwealth in urging you to require an independent health impact assessment prior to authorization of any natural gas infrastructure projects in the Commonwealth.

Natural gas flowing through pipelines contains volatile contaminants, such as benzene and formaldehyde, which can cause human illnesses, even at low concentrations. Releases are routine, whether from leaks or maintenance. The Commonwealth has an obligation to protect the health of its citizens; yet, the potential health effects of natural gas pipelines are not being examined to the extent that the Public’s health and welfare is being protected to the best of the Commonwealth’s capability.

The Lowell Board of Health believes more effective regulation of existing natural gas pipelines to minimize adverse health effects is required. This perspective is shared by national health organizations, including the American Medical Association:

“Our AMA recognizes the potential impact on human health associated with natural gas infrastructure and supports legislation that would require a comprehensive Health Impact Assessment regarding the risks that may be associated with natural gas pipelines.”

The Massachusetts Medical Society (MMS) has adopted the following policies:

1. That the MMS recognizes the potential impact on human health associated with natural gas infrastructure. (HP) 2. That the MMS advocate to appropriate agencies and the Massachusetts state legislature to require ongoing independent Comprehensive Health Impact Assessments to assess the human health risks of all existing and proposed new or expanded natural gas infrastructure in Massachusetts. (D)

This is an issue of great urgency as new pipelines that may impact the public health are being considered for Massachusetts. The Lowell Board of Health encourages your Administration to require health impact assessments of high pressure fracked gas infrastructure projects prior to any further expansion or new construction occurs. The Board also encourages your Administration to support the expansion of clean renewable energy programs that will lessen the health risk impacts for the citizens of the Commonwealth.

Sincerely,

______

______

______

______

______City of Lowell Board of Health COMMONWEALTH OF MASSACHUSETTS

CITY OF LOWELL

In Citv Council ORDINANCE

An Ordinance creating one (1) new position and salary of Syringe Collection Program Coordinator at the Health and Human Services Department.

The City Council, by vinue of the Massachusetts General Laws, Chapter 43, Section 105, has the authority to create and"/or delete positions.

BE IT ORDAINED BY THE CITY COLINCIL OF THE CITY OF LOWELL, as foIIowS:

The Code of Ordinances City of Lowell, Massachusetts, hereinafter called the "Code" adopted by the City Council on December23,2008, as amended, is hereby further amended as follows:

1. The following position and salary is created at the Health and Human Services Department:

One (1) Full Time, Syringe Collection Program Coordinator AFSCME Local2532 Salary - $43,761.12 (min) to $47,063.12 (mar) (35 hours/wk)

The above position and salary created by this Ordinance shall be filled only when the necessary funds for said position have been appropriated and said position and salary shall be eliminated when said funds are no longer available. 2. All pmvisions of the Code of fte City of Lowell, as mended, which are not inconsistent with this Ordinancc shall continue in effsct, but all provisions of said Code inconsistent herewith ae repealed.

3. This Ordnance shall take effect upon its pEssage in accordancc with the provisions of Cbaptcr 43 and 40A ofthc Creneral Laws of the Commonwealth of lvlasaphusetts.

APPROVED AS TO FORM:

Christirc P. O'Connor City Solicitor

Ondinfltancelpersonnelh€alrlwtdhumanserv/syringe The City of Lowell ' Health Department 34L Pine Street ' Lowell, MA 01851 P: 978.67 4.4010' F: 978.970.407'l' www.LowellMA'gov

Kerran Vigroux, BS, MPH Director of Health tc Human Seraices 978.674.L050

MEMORANDUM

TO: Eileen Donoghue, City Manager FROM: Kerran Vigroux, Director, Health and Human Services Department Date: October 24,2018 Subject: Syringe Collection Program Coordinator

As with many communities throughout the Commonwealth and beyond, Lowell has struggled with the Opioid Crisis and the resulting numbers of discarded syringes in our public areas. The City has attempted to piece together response procedures over the past year including City- wide employee general awareness trainings, training and vaccination of select employees to collect the syringes, and partnering with Trinity Ambulance, Inc., to cover days/hours when the City staff was not available.

Despite these attempts, it has become clear that the City is in need of a more coordinated approach which is capable of proactive strategies rather than simply being reactive. The creation of a Syringe Collection Program Coordinator position will do just that. The Coordinator will oversee the Syringe Collection Program which will be based out of the Substance Use and Prevention Division of the Lowell Health and Human Services Department. This is the same department which oversees the CO-OP team and several Opioid-related grants that are funded by the Massachusetts Department of Public Health.

The Syringe Collection Program Coordinator will be responsible for coordinating the City's efforts of syringe collection and community education regarding safe syringe access and disposal. The public will be able to call in or report locations of discarded syringes through an online portal, similar to when a pothole is reported. lt will be the Coordinator's responsibility to respond, collect and dispose of the syringe(s) in an appropriate and safe manner. The Health Department currently has a contract with a company for the handling of bio-medical waste for regular pick-ups of all used syringes that are generated from vaccination clinics, syringe collection events, and regular syringe drop-offs at the Senior Center.

The Syringe Collection Program will not be distributing syringes in the community. The Coordinator will, however, be working with several Community organizations that engage in Syringe Service Programs funded by the Massachusetts Department of Public Health. Working collaboratively with these organizations will ensure that there is minimal duplication of services rhe city "tLOWILL Atipe. LInitTut. Inspiritts The City of Lowell ' Health Department 341 Pine Street ' Lowell, MA 01851 k 978.674.4010 ' F: 978.970-4077 www.LowellMA.gov

Kerran Vigroux, BS, MPH Director of Health I Human Seraices 978.674.L050 and that members of the community will know where to access the most appropriate services for their needs.

Trinity Ambulance, lnc. has agreed to continue to cover evening and weekend reports of syringes found in public areas in the City. Large sites that are deemed too hazardous for the Coordinator or Trinity Ambulance to access or manage will be referred to Development Services for assessment.

Funding for the position is available through June 30, 2019 from the Health Department's budget. lt is proposed that this will be sufficient time to pilot this position and program and to evaluate its effectiveness.

We are respectfully requesting approval to move forward with the creation of the Syringe Collection Program Coordinator position and the subsequent hiring of the most qualified candidate. This position is a 35 hours/week, union position with an hourly range of $ 24.04 per hour - $ 25.86 Per hour.

rhe city "tLowELL Atiae. utrique. Inspirirrs. Lowell Health Department Public Health Nursing

September 2018

Submitted by Colleen da Silva, RN, Public Health Nurse Manager

Communicable Diseases Reported

Disease Sept. 2017 Sept. 2018 2017 Total 2017 YTD 2018 YTD

Amebiasis 1 2 1 1 Anthrax 1 Arbovirus 1 1 1 Babesiosis 1 5 4 3 Calcivirus/Norovirus 4 3 3 Campylobacteriosis 1 2 17 12 9 Clostridium perfringens 1 1 1 Cryptococcus neoformans 1 1 1 Cryptosporidiosis 1 2 11 10 11 Dengue Fever 4 4 Ehrlichiosis 4 4 1 Enterovirus 1 1 Giardiasis 2 14 14 13 Group A Streptococcus 3 4 62 55 46 Group B Streptococcus 15 12 3 Haemophilus Influenzae 1 2 2 1 Hepatitis A 1 4 2 3 Hepatitis B 10 19 159 91 156 Hepatitis C 11 25 232 188 176 Hepatitis D 1 Human Granulocytic Anaplasmosis 1 5 4 7 Influenza 1 837 749 1518 Legionellosis 2 2 7 Lyme Disease 5 5 81 66 52 Malaria 3 13 12 Measles 3 3 3 Meningitis – Unknown Type 1 1 2 Mumps 1 1 1 Pertussis (and other Bordatella species) 1 8 7 Rocky Mountain Spotted Fever 1 2 1 1 Rubella 1 1 Salmonellosis 2 1 22 22 17 Shiga toxin producing enzyme 2 5 5 1 Shigellosis 1 7 5 1 Streptococcus pneumoniae 1 14 10 12 Tickborne (other) 1 Toxoplasmosis 1 Varicella 1 13 10 8 Viral Meningitis (aseptic) 1 West Nile Virus Infection 2 1 Yersiniosis 1 1 Zika Virus Infection 48 47 1 *denotes case is connected to a foodborne illness investigation

Tuberculosis Cases Reported Sept. 2017 Sept. 2018 2017 Total 2017 YTD 2018 YTD TB LTBI 34 26 450 316 270 TB Active 0 2 14 13 26 B1 Waivers 2 2 15 13 10

Total of 10 DOTs done in September 2018

Refugee Arrivals Total Families/Total Persons

Sept. 2017 Sept. 2018 2017 Total 2017 YTD 2018 YTD 54/121 49/101 16/51

Immunizations Vaccine Sept. 2017 Sept. 2018 2017 Total 2017 YTD 2018 YTD Influenza 114 221 283 122 221

Public Health Nurse Activities Participated in 2nd round interview for public health nurse position Provided nurse representation to Medication Take Back Day held at the Health Department Represented the Health Department at National Park PARKing Day Managed Employee/Retiree Flu Clinics at City Hall and Summit Elder Care Attended Domestic and Sexual Violence Training for Nurses Attended Mass. Assn. of Public Health Nurses meeting at Tewksbury State Hospital Provided DOTs to active TB cases Attended TB Clinic with active TB cases and B waivers Conducted contact investigations for new active TB patients Consulted with MDPT TSA (Tuberculosis Surveillance Area) nurse regarding new active TB cases Investigated communicable diseases reported in Lowell residents Provided information, referrals, and education to community residents and medical providers who contact the Health Department Communicated with Animal Control regarding animal bites/rabies testing Provided education and guidance to physician’s offices regarding TB and communicable diseases.

Public Health Nurse Manager Activities Attended Mass. Assn. of Public Health Nurses meeting at Tewksbury State Hospital Began interview process for hiring 2 Public Health Nurses for the Health Department (held first and second round interviews) Attended Domestic and Sexual Violence Training for Nurses Participated in Medication Take Back Day planning Attended Board of Governor’s meeting of Health and Medical Care Coalition (Region 3) Participated in planning for Health Department representation at National Park PARKing Day Provided DOTs to active TB case Investigated communicable diseases reported in Lowell residents Provided information, referrals, and education to community residents and medical providers who contact the Health Department Communicated with Animal Control regarding animal bites/rabies testing Provided education and guidance to physician’s offices regarding TB and communicable diseases.

Board of Health

September Monthly Report-School Health Unit

School Nursing Services Provided 17-Sep 18-Sep Total 17-18 YTD 2018 Total Student Encounters Totals 14,992 12,858 151,903 12,858 911 Emergency Calls - Student 5 13 60 13 Staff 2 2 14 2 Medication Administration - Totals 3,498 3,158 44,499 3,158 Nursing Assessment - Student 9,059 9,001 86,879 9,001 Staff 5 67 323 67 Glucose Testing 819 664 6,786 664 Nausea/vomiting 10 1,092 9,989 1,092 Tube Feedings 247 133 2,587 133 pulse Oximetery 15 18 325 18 Screenings - Vision 1,021 662 9,475 662 Hearing 669 424 7,343 424 BMI 222 206 2,935 206 Postural 57 38 4,323 38 Total 1,969 1,330 24,076 1,330

Epipen training was done by the school nurses in all 29 schools. Fall coaches were also Epipen trained.

School Nurse Coordinator & Clinical Nurse Managers continue to collaborate with our community partners in the interest of health and wellness and have attended:

Mental Health Coalition, Asthma Coalition, Lowell Community Health Center Meeting , Greater Lowell Pedi Meeting, SBIRT meeting , and a School Safety Summit. Board of Health Meeting – November 7th, 2018 Division of Substance Abuse and Prevention Lowell Health Department

Substance Abuse Coordinator Lainnie Emond, LMHC

Prescription Drug Monitoring Program (PDMP) Grant Initiatives:  Continuing to work with the Chair of the Mayor’s Opioid Epidemic Crisis Task Force to plan monthly meeting agendas, identify potential initiatives, contact presenters, and invite new agencies. o Recent/Upcoming Meetings: 10/29 and 11/26 from 5:30-6:30pm in the Mayor’s Reception Room within City Hall  Hosted Data Subcommittee meetings for the Mayor’s Opioid Epidemic Crisis Task Force on 11/5. Continuing to identify data sources within the agencies at the table. Working to overlap datasets from various agencies by zip code and neighborhood, as a means to comply with HIPAA, to identify areas of need in regards to substance abuse services and outreach. The Subcommittee is also bringing together data to make a linear representation of the substance abuse programing/initiatives, fatal and nonfatal overdoses, and other related factors in Lowell in hopes of being able to make correlations that could influence future programming/funding in Lowell. o Recent/Upcoming Meetings: 10/1and 11/5 1-2pm at EOC within LPD  Continuing partnership with LPD and UML re: PDMP grant to begin creating a “Death Database” as a means to retroactive study the lives of fatal opioid overdose victims. We plan to analyze victims’ encounters with first responders, medical services, and other professionals to see where opportunities for harm reduction and education may have been missed as an effort to identify new opportunities for client engagement moving forward.

Smart Policing Initiative Grant  Lainnie has continued to work in partnership with LPD and UML researchers on fine tuning data points that the Lowell CO-OP collects during their day-to-day client encounters. Has also been involved in identifying an evidenced based tool that identifies client progress.

Other:  Health and Police Departments have planned a Remembrance and Recovery Vigil scheduled for 10/25 to remember those who have lost their lives to substance abuse disorder and to honor to those in recovery.  Lainnie has been working on an “Overdose Tracking” specific to Lowell. The tracking consists of daily nonfatal opioid overdose number from of Trinity EMS, weather (daily high and low), crime as reported via “CrimeMapping.com”, crime as reported by local news sources, program closings, and other events taking place in the city such as house fires, festivals, and fatal accidents. The intention is to collect several months of data to see if there are potential correlations between increases in nonfatal opioid overdoses and local “events”.

Massachusetts Opioid Abuse Prevention Collaborative (MOAPC) Michael Hall M.Ed.

Strategy One (implement Life Skills Training across the cluster): Life Skills Training is an evidenced based prevention curriculum supported by the Bureau of Substance Addiction Services.  MOAPC Coordinator facilitated a Life Skills Training (LST) Prevention Certification training for cluster public school teachers. Four school systems were represented. With the additional consultation I am providing, the newly certified attendees are on track to implement LST by the end of November 2018.  Additionally, after a summer of working with The Nan Project in training their staff in high school transitions level LST, the Director of The Nan Project has met with Lowell High School and is hoping to bring Peer Mentors from The Nan Project into Lowell High School to bring awareness to mental health support and suicide.

Grant Strategy Two (coordination and promotion of education on harm reduction strategies):  On 10/4 at the Quarterly State meeting with BSAS and MOAPC Leaders across the state, I initiated the beginning discussions around how MOAPC can work within the limitations of the grant to create more access to Narcan in our community. At the beginning stages of the discussion are plans to identify highest areas of need and train Narcan trainers appropriately with a focus on sustaining these efforts and retaining trainers. This discussion continues and is in basic planning stages.  At MOAPC Coalition meetings, we are continuing to identify needs for harm reduction awareness (with a focus on Narcan trainings) along with each community identifying possible sustainable resources in each community.

Additional MOAPC activities include:  Billerica Substance Abuse Prevention o On 10/17 MOAPC Coordinator assisted in the facilitation of Billerica’s Community Substance Mis-Use forum. This 5 hour event was held in coordination with Billerica Public Schools and well attended by the public.  Chair of the Merrimack Valley Substance Use Symposium scheduled for December 7th at UTEC in Lowell. This symposium is being developed by many community partners and town representatives (Lowell, GLHA, Billerica, Westford, Trinity, CO-OP, Tewksbury, UMass Lowell, LCHC, among others) to providers across the Merrimack Valley out of the silos to meet, network, and strategize coordination of services moving forward. (meeting weekly through 12/7 - the day of the symposium)  Ongoing work in the planning and creation of a renewed Drugfreegreaterlowell.org website. This effort has been under development for over a year and is finally moving forward.  10/25 MOAPC contributed to and supported coordination of Lowell’s Vigil/Night of Remembrance  MOAPC funded cluster members attending the MIAA Wellness Conference on 10/26. A main topic at this conference is around E-Cigarettes and Vaping, its connection to underage drug use, and how to address and prevent youth in using these products.  Completed the Quarterly BSAS report on cluster MOAPC activity Partnerships for Success (PFS) Lainnie Emond is currently acting as interim PFS Coordinator until position is filled.

Strategy One (social media and education dissemination to high school-aged youth re: sharing prescription medications):  Lowell High School: Interim PFS Coordinator has continued to meet with school officials to identify ways that PFS can educate youth, including the utilization of a social media campaign.  Middlesex Community College: Jonathan Crocket, Director of Athletics, Health, and Wellness, has been a bridge to PFS educating first year students. PFS attended a resource fair on 10/10 at the college, and have been invited to present during several classes.  Pyne Arts Magnet School: Interim PFS Coordinator presented during a Generation Citizen class of 48 eighth graders on current and upcoming legislation pertaining to substance abuse disorder/resources. The class intends to create a project around a piece of legislation that they believe will be impactful to their community.  Teen Block (LCHC): PFS will be partnering with SAPC to run 1.5 hour substance abuse groups on Monday afternoons through December.  Social Media Campaign: The PFS social media campaign to educate youth against the dangers of sharing prescription medications has been spearheaded by Kate Elkins, Community Health Coordinator at the Lowell Health Department. Kate has run two youth focus groups with the proposed social marketing materials, one at Teen Block on 10/1 and another at the Boys and Girls Club on 10/24.

Strategy Two (social media and education dissemination to parents/guardians and high school-aged youth re: proper disposal and storage):  PFS is creating a one page handout identifying strategies to store and dispose of unwanted prescription medications.

Monthly Meeting:  10/17

PFS Grant Coordinator Position Updates  First round interviews are being scheduled for the last week of October and the first week of November.

Other  Interim PFS Coordinator attended the MassTAPP Quarterly meeting for MOAPC, PFS and SAPC grant holders.

Lowell Community Opioid Outreach Program (CO-OP) Maricia Verma

Presentations and Rapport Building:  10/22 CO-OP invited Joe Aniello and Danial Howell from LCHC to attend the first part of the CO-OP meeting; topics of discussion included transportation to treatment and best ways to collaborate.  10/12 Middlesex Sheriff’s Office (Lowell Community Corrections Office) presented at DA Marion Ryan’s Opioid Task Force Meeting, and CO-OP Supervisor was asked to briefly present about CO-OP as CO-OP has an office in the community office.  Lowell Police Academy asked CO-OP to present to new recruits; date is TBD

Meetings:  9/26, 10/22 CO-OP Meeting  10/3, 10/30 CO-OP Supervisors Meeting

Trainings:  10/23/2018 CPR/First Aid Training attended by CO-OP Supervisor, Lowell House Outreach Worker, and Trinity EMT

Clinical Recovery Specialist (CRS) Active Client Caseload Summary: Active Clients: 17

Total CO-OP Initial and Attempted Initial Encounters: 38

Client Outreach Highlights:  Multiple clients requested CO-OP’s assistance in advocating for admittance to the shelter.  Continued distribution of bottled water and bandages  CO-OP received Bleach Kits, condoms, female condoms, and lube from the Health Department via MDPH for distribution to clients  CO-OP continues to see periodic reference of meth use in overdose reports  CO-OP has started to hear that substance abusing clients are snorting Wellbutrin to obtain an amphetamine-like high.

CRS Hiring Process  First round interviews for the two empty CRS positions were held on 10/12 and 10/19.  Once candidate has been scheduled for a second interview on 11/5.