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Downloaded from Intermittent vs. continuous oxygen saturation monitoring for infants hospitalized with bronchiolitis: study protocol for a pragmatic randomized controlled trial ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2018-022707 Article Type: Protocol Date Submitted by the Author: 08-Mar-2018 Complete List of Authors: Mahant, Sanjay; The Hospital for Sick Children, Paediatrics Wahi, Gita; McMaster University, Department of Health Research Methods, Evidence, and Impact; McMaster University, Department of Pediatrics Giglia, Luci; McMaster University, Pediatrics Pound, Catherine; University of Ottawa; Children's Hospital of Eastern Ontario Kanani, Ronik; North York General Hospital, University of Toronto, Pediatrics Bayliss, Ann; Trillium Health Partners, University of Toronto Roy, Madan; McMaster University, Pediatrics Sakran, Mahmoud; Lakeridge Health, Queens University, Pediatrics Kozlowski, Natascha; Lakeridge Health Breein-Reid, Karen; Hospital for Sick Children, Nursing http://bmjopen.bmj.com/ Lavigne, Mollie; Hospital for Sick Children, Quality and Risk Management Premji, Laila; Hospital for Sick Children, Pediatrics Willan, Andy; University of Toronto Moretti, Myla; The Hospital for Sick Children, University of Toronto, SickKids Research Institute Schuh, Suzanne; Hospital for Sick Children, Pediatricis Parkin, Patricia; The Hospital for Sick Children, Pediatric Medicine Keywords: bronchiolitis, pulse oximetry, randomized controlled trial on September 29, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 29 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2018-022707 on 20 April 2018. Downloaded from 1 2 3 Intermittent vs. continuous oxygen saturation monitoring for infants hospitalized 4 with bronchiolitis: study protocol for a pragmatic randomized controlled trial 5 6 7 Mahant S, Wahi G, Giglia L, Pound C, Kanani R, Bayliss A, Roy M, Sakran M, 8 Kozlowski N, Breen-Reid K, Lavigne M, Premji L, Moretti ME, Willan A, Schuh S, 9 Parkin PC 10 11 Sanjay Mahant MD FRCPC MSc 12 Associate Professor 13 14 Division of Paediatric Medicine, Paediatric Outcomes Research Team (PORT), 15 Department of Paediatrics and Institute of Health Policy, Management and Evaluation, 16 University of Toronto;For Research peer Institute, review Hospital for Sick only Children 17 555 University Avenue, Toronto, Ontario, Canada 18 M5G1X8 19 Email: [email protected] 20 21 22 Gita Wahi MD FRCPC MSc 23 Assistant Professor 24 Department of Paediatrics, McMaster University 25 Hamilton Health Sciences Centre, HSC-3A78 26 1280 Main Street West 27 Hamilton, Ontario L8S 4K1 28 29 Email: [email protected] 30 31 Luci Giglia MD FRCPC MSc 32 Associate Professor http://bmjopen.bmj.com/ 33 Department of Paediatrics, McMaster University 34 Hamilton Health Sciences Centre, HSC-3N27 35 1280 Main Street West 36 37 Hamilton, Ontario L8S 4K1 38 Email: [email protected] 39 40 Catherine Pound MD FRCPC MSc on September 29, 2021 by guest. Protected copyright. 41 Assistant Professor 42 Department of Paediatrics, University of Ottawa 43 44 Children’s Hospital of Eastern Ontario 45 401 Smyth Rd, Ottawa, ON K1H 8L1 46 Email: [email protected] 47 48 Ronik Kanani MD FRCPC 49 Assistant Professor, Department of Paediatrics, University of Toronto 50 North York General Hospital 51 52 Email: [email protected] 53 54 Ann Bayliss MD FRCPC 55 Department of Paediatrics, Trillium Health Partners, University of Toronto 56 57 58 59 1 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 29 BMJ Open: first published as 10.1136/bmjopen-2018-022707 on 20 April 2018. Downloaded from 1 2 3 2200 Eglinton Avenue West 4 Mississauga, Ontario L5M 2N1 5 6 Email: [email protected] 7 8 Madan Roy 9 Associate Professor 10 Department of Paediatrics, McMaster University 11 Hamilton Health Sciences Centre, Room 3N11 12 1280 Main Street West 13 14 Hamilton, Ontario L8S 4K1 15 Email: [email protected] 16 For peer review only 17 Mahmoud Sakran MD 18 Assistant Professor, Queens University 19 Lakeridge Health 20 21 Oshawa, Ontario 22 Email: [email protected] 23 24 Natascha Kozlowski, MPH 25 Director, Research 26 Lakeridge Health 27 Oshawa, Ontario 28 29 Email: [email protected] 30 31 Karen Breen-Reid, MSN 32 Manager, Interprofessional Education, Learning Institute http://bmjopen.bmj.com/ 33 Hospital for Sick Children, 34 Adjunct Lecturer, Lawrence Bloomberg Faculty of Nursing, University of Toronto 35 555 University Avenue, Toronto, Ontario 36 37 M5G1X8 38 Email: [email protected] 39 40 Mollie Lavigne, MSN, NP-Paediatrics on September 29, 2021 by guest. Protected copyright. 41 Adjunct Lecturer, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto 42 The Hospital for Sick Children 43 44 555 University Avenue 45 Toronto, Ontario M5G1X8 46 [email protected] 47 48 Laila Premji, MD FRCPC 49 Division of Paediatric Medicine 50 Hospital for Sick Children 51 52 555 University Avenue, Toronto, Ontario 53 M5G1X8 54 Email: [email protected] 55 56 57 58 59 2 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 29 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2018-022707 on 20 April 2018. Downloaded from 1 2 3 Andy R. Willan, PhD 4 Professor of Biostatistics 5 6 Dalla Lana School of Public Health 7 Ontario Child Health Support Unit 8 Research Institute, Hospital for Sick Children 9 555 University Avenue, Toronto, Ontario 10 M5G1X8 11 Email: [email protected] 12 13 14 Myla E. Morretti, PhD 15 Health Economist, 16 Clinical Trials Unit-OntarioFor peer Child Health review Support Unit only 17 The Hospital for Sick Children 18 555 University Avenue, Toronto, Ontario 19 M5G1X8 20 21 Email: [email protected] 22 23 Suzanne Schuh MD FRCPC 24 Professor 25 Division of Emergency Medicine, Department of Paediatrics, University of Toronto 26 Research Institute, Hospital for Sick Children 27 555 University Avenue, Toronto, Ontario 28 29 M5G1X8 30 Email: [email protected] 31 32 Patricia C. Parkin MD FRCPC http://bmjopen.bmj.com/ 33 Professor 34 Division of Paediatric Medicine, Paediatric Outcomes Research Team (PORT), 35 Department of Paediatrics and Institute of Health Policy, Management and Evaluation, 36 37 University of Toronto; Research Institute, Hospital for Sick Children 38 555 University Avenue, Toronto, Ontario 39 M5G1X8 40 Email: [email protected] on September 29, 2021 by guest. Protected copyright. 41 42 43 44 Corresponding Author: 45 46 Sanjay Mahant, MD FRCPC MSc 47 Hospital for Sick Children 48 555 University Avenue, Toronto, Ontario, Canada 49 M5G1X8 50 Email: [email protected] 51 52 Mobile: 416.846.1602 53 Office: 416.813.5280 54 55 56 57 58 59 3 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 29 BMJ Open: first published as 10.1136/bmjopen-2018-022707 on 20 April 2018. Downloaded from 1 2 3 Keywords: bronchiolitis; pulse oximetry; randomized controlled trial; pragmatic trial; 4 length of stay; safety; cost 5 6 7 Protocol Version date: March 7, 2017 8 9 Word Count: 4,257 10 11 12 13 14 15 16 For peer review only 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39 40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 4 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 5 of 29 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2018-022707 on 20 April 2018. Downloaded from 1 2 3 4 ABSTRACT 5 6 7 Introduction: Bronchiolitis is the most common reason for hospitalization in infants in 8 developed countries. The main focus of hospital care is on supportive care, such as 9 monitoring for hypoxia and supplemental oxygen administration, as active therapies lack 10 effectiveness. Pulse oximetry is used to monitor hypoxia in hospitalized infants and is 11 used either intermittently or continuously. Observational studies have suggested that 12 continuous pulse oximetry use leads to a longer length of hospital stay in stable infants. 13 14 The use of continuous pulse oximetry may lead to unnecessary clinical intervention due 15 to readings that are of little clinical significance, false positive readings and less reliance 16 on the clinical status.For There peer is a lack of review high quality evidence only to guide which pulse 17 oximetry monitoring strategy, intermittent or continuous, is superior in infants 18 hospitalized with bronchiolitis with respect to patient and policy-relevant outcomes.