Does Femoral Venous Pressure Measurement Correlate Well with Intra-Bladder Pressure Measurement

DOES FEMORAL VENOUS PRESSURE MEASUREMENT CORRELATE WELL WITH INTRA-

BLADDER PRESSURE MEASUREMENT?: A MULTICENTER OBSERVATIONAL TRIAL.

Bart L De Keulenaer1 MD, FCICM, Adrian Regli1 MD, EDIC, FCICM, Wojciech Dabrowski2 MD, PhD,

Vaxtang Kaloiani3, Zsolt Bodnar4, Javier Izura Cea5, Andrey Litvin A6, Wendy A Davis7 PhD, Anne-Marie

Palermo1, Jan J De Waele8, Manu LLNG Malbrain MD,PhD9

ELECTRONIC SUPPLEMENTARY MATERIAL Electronic Table 1. Study centres who participated in the trial

Centre number Number of patients Country De Keulenaer 2 55 Australia Litvin 3 4 Bealrus Kaloiani 4 15 Georgia De Waele 5 2 Belgium Izura Cea 6 4 Spain Dabrowski 7 63 Poland Bodnar 8 6 Hungary

Electronic Table 2 Bland and Altman analysis and Spearman’s rank correlation coefficient

IAP FVP Bias Precis LAa UAb SRCc R2 P-value Nd ion Day 1

Time 1 11.44.2 12.95.0 -1.5 4.0 -9.4 6.3 0.70 0.45 < 0.0001 149 Time 2 11.64.6 13.24.8 -1.6 3.9 -9.2 5.9 0.70 0.45 < 0.0001 149 Time 3 11.64.6 13.44.8 -1.8 3.6 -8.9 5.2 0.70 0.45 < 0.0001 149 Day 2 Time 1 11.34.6 12.74.6 -1.4 3.9 -8.9 6.2 0.67 0.45 < 0.0001 143 Time 2 11.14.6 12.44.4 -1.3 3.3 -7.8 5.2 0.72 0.51 < 0.0001 142 Time 3 10.54.6 11.84.1 -1.3 3.2 -7.7 5.1 0.69 0.47 < 0.0001 134 Day1+ Day2 11.24.5 12.74.7 -1.5 3.6 -8.6 5.7 0.46 0.21 <0.0001 866 IAP1 2 15.72.7 16.14.0 -0.4 3.9 -8.1 7.3 0.38 0.14 <0.0001 343 aLower limits of agreement (lower and upper limits respectively); bUpper Limits of agreement; cSpearman’s coefficient of rank correlation; R2 , coefficient of determination; Data are expressed as meanSD;dnumber of measurements Electronic Table 3 Comparison of intra-abdominal pressures amongst different weight groups

Study IAP (mean+SD) by obesity status characteris tics N (observ) Normal Overweighta Obeseb Morbidly obesec Sanchez [39] 77 (231)d 5.0 ± 2.9 6.3±2.9 8.9±3.5 8.4 ± 2.5

Sugerman[40] 84 (84) 5.1 ± 1.2 NA NA 13.2±0.5 Sugerman[41] 15 (15) NA NA 7.4 ± 0.7 NA Lambert[42] 45 (45) 0 ± 1.5 NA NA 8.8 ± 0.6 Vasquez [43] 45 (675) 6.5 (4.5-8.5) 11.2 (7.7-14.6) 13.7 (11.4-16.0) NA Arfvidsson[1 15 (15) 6.2 ± 1.2 NA NA 14 ± 3 3]

Sugerman[44] 6 (6) NA NA 12.5 16.2 ± 2.2 Present study 149(864) 9.9±4.1 11.3±3.7 13.8±3.8 aBMI 25.0-29.9 kg/m2; bBMI 30.0-39.9 kg/m2; cBMI 40 kg/m2 ; dIAP observations

Electronic Table 4 Comparison of intra-abdominal pressures in the obese and normal weight groups

IAP N non- BMI<30 kg/m2 N obese BMI≥30 kg/m2 P-value obese Day 1 Time 114 10.6±4.0 35 13.8±3.8 <0.001 1 Day 1 Time 114 11.0±4.5 35 13.6±4.4 0.003 2 Day 1 Time 114 11.0±4.7 35 13.4±3.9 0.003 3 Day 2 Time 111 10.8±4.9 33 12.6±3.6 0.056 1 Day 2 Time 109 10.6±4.7 33 12.8±3.7 0.005 2 Day 2 Time 101 9.9±4.0 32 12.4±3.5 0.002 3 Electronic Fig. 1 Bland and Altman plot of the difference between intra-abdominal pressure and femoral venous pressures in patients with a BMI < 30 kg/m2

+1.96 SD 0 3 5 5.7 s s e l

p v c I 0 Mean M B

- -1.4

s -5 s e l

p -1.96 SD a i I -8.5 M -10 B

-20 0 5 10 15 20 25 30 AVERAGE of BMIiap less 30 and BMIcvp less 30 Electronic Fig. 2 Bland and Altman plot of the difference between intra-abdominal pressure and femoral venous pressures in patients with a BMI > 30 kg/m2

+1.96 SD 5 5.4 0

p Mean v c I -1.9 M B

p -1.96 SD a i I -10 M -9.3 B

-20 0 5 10 15 20 25 AVERAGE of BMIiap>30 and BMIcvp>30 Electronic Figure 3 Receiver operating curve analysis for femoral venous pressure to detect an intra- abdominal pressure equal or above 12 mmHg.

FVP 100

60 y t i v i t i s n e S 40

0 0 20 40 60 80 100 100-Specificity

Electronic supplementary material: The Case Report Forms for each patient

As developed by the Clinical Trials Workgroup of the World Society of the Abdominal Compartment Syndrome COMPARING ILEOFEMORAL/INFERIOR VENA CAVA VENOUS PRESSURE MONITORING WITH THE STANDARD IAP MEASUREMENTS VIA THE BLADDER

MULTICENTER TRIAL Dr Bart De Keulenaer PATIENT NAME: ______

MEDICAL RECORD NUMBER: ______

DATA COLLECTION FORMS

INSTRUCTIONS

 These data collection sheets should be used to record the data points for the study.

 Enter the study site number assigned to your institution on the top of each data collection sheet.

 Enter the number of each patient enrolled at your site in sequential order. For example, the first patient should be “001”, the second “002”, the third “003”, etc…

 Enter the patient’s name and medical record number to assist in data collection at your study site.

 Please keep a copy of all data collection sheets for 5 years. PATIENT SCREENING

Please indicate that the following inclusion criteria have been met:

Yes No Informed consent signed (please attach a copy of the consent to the data collection sheets) OR waiver of informed consent granted

Yes No Patient is at least 18 years of age

Yes No All patients are mechanically ventilated

Patient is excluded from the study because (check if applies):  There is not a commitment on the part of the medical team, the subject, or the subject’s family to full aggressive support, including operative intervention if indicated.  Patient is unable to tolerate changes in bed position due to spinal precautions, intracranial hypertension, hemodynamic instability, or any other reason.  Patient is pregnant PATIENT DEMOGRAPHICS

Gender Male  Female 

Weight (kg)

Height (cm)

ICU admission diagnosis (please describe)

 COPD  Chronic renal Failure  Diabetes  Heart Disease  Liver D  Malignancy  Venous insufficiency  Sleep apnoe Co-morbidities  Hypertension  Hyperlipidemia  Other: BASELINE ASSESSMENT Calculate the following scores using the attached worksheets and enter values in the boxes below.

APACHE-II score

SOFA score

SAPS-2 score

LINE INSERTION

Date inserted

 Left Femoral  Right Femoral

Type  vascath

 double lumen

 triple lumen

 quadriple lumen

 other:

Antibiotic  Yes antiseptic impregnated  No catheter MEASUREMENT SET #1

Date: ______

RASS score: ______

Positive end-expiratory pressure: ______(cm H2O)

Is the patient’s abdominal fascia closed? (please check) Yes  No 

Intra-abdominal pressure (IAP) measurements at 2 hourly intervals:

Femoral central Mean arterial Day 1 IAP Temperature venous pressure (CVP) pressure (MAP)

Time 1:

Time 2:

Time 3:

Comments: ______MEASUREMENT SET #2

Date: ______

RASS score: ______

Positive end-expiratory pressure: ______(cm H2O)

Is the patient’s abdominal fascia closed? (please check) Yes  No 

Intra-abdominal pressure (IAP) measurements at 2 hourly intervals:

Day 2 IAP Femoral CVP Temperature MAP

Time 1:

Time 2:

Time 3:

Comments: ______OUTCOME ASSESSMENT

ACS: Yes  No 

If “Yes” to ACS, please explain: Did patient develop ACS at any time? ______

Yes  No  Was a decompressive If decompressive laparotomy was necessary, please explain: laparotomy necessary (includes ______temporary abdominal closure)?

 Date:

 Tip send for culture Yes  NO

If Yes  negative (CFU<15)

 positive (CFU >15)

If positive: What Organism: Removal femoral central line  Signs of skin infection Yes  NO

 Bacteraemia Yes  NO

If Yes: What Organism:

Patient outcome at  Alive ICU discharge?  Dead  Ventilator dependent

Other  Haematoma complications Central line  Thrombus RICHMOND AGITATION SEDATION SCORE (RASS)

Score Term Description +4 Combative Overtly combative or violent; immediate danger to staff +3 Very agitation Pulls on or removes tube(s) or catheter(s) or has aggressive behavior toward staff +2 Agitated Frequent nonpurposeful movement or patient–ventilator dyssynchrony +1 Restless Anxious or apprehensive but movements not aggressive or vigorous 0 Alert and calm -1 Drowsy Not fully alert, but has sustained (more than 10 seconds) awakening, with eye contact, to voice -2 Light sedation Briefly (less than 10 seconds) awakens with eye contact to voice -3 Moderate sedation Any movement (but no eye contact) to voice -4 Deep sedation No response to voice, but any movement to physical stimulation -5 Unarousable No response to voice or physical stimulation SEQUENTIAL ORGAN FAILURE ASSESSMENT (SOFA) SCORE

Determine score based upon the 24 hour period prior to the first study IAP measurement.

Add the points for each of the six (6) variables to determine the total SOFA score.

Variable 0 1 2 3 4

PaO2/FiO2 (mmHg) > 400 ≤ 400 ≤ 300 ≤ 200 ≤ 100 Platelets (103/L) > 150 ≤ 150 ≤ 100 ≤ 50 ≤ 20 Bilirubin (mg/dL) < 1.2 1.2-1.9 2.0-5.9 6.0-11.9 > 12 Dopamine > 15 Dopamine > 5 Dobutamine > 15 Dobutamine > 5 Dopexamine > 15 Hypotension None MAP < 70 mmHg Dopamine ≤ 5 Dopexamine > 5 Epinephrine> 0.1 Epinephrine ≤ 0.1 Norepinephrine> 0.1 Norepinephrine ≤ 0.1 Vasopressin (any dose) Glascow Coma 15 13-14 10-12 6-9 < 6 Score Creatinine (mg/dL) < 1.2 1.2-1.9 2.0-3.4 3.5-4.9 > 5

Drug dosages in mcg/kg/min

TOTAL SOFA SCORE = ______SAPS-2 SCORE WORKSHEET Step 1: Determine the Admission Type points Admission type points: ______ Surgery scheduled more than 24 hours before admission (0 points)  Medical - no surgery within one week of admission (6 points)  Unscheduled surgery (8 points)

Step 2: Determine the Chronic Illness points Chronic illness points: ______ Documented metastatic cancer (9 points)  Lymphoma, leukemia, multiple myeloma (10 points)  Clinical AIDS (HIV + with symptoms) (17 points)

Step 3: Calculate the Physiologic points Physiologic points: ______Circle the appropriate range for the worst value within the 24 hours prior to the first study IAP measurement. Add the points for each physiological variable to determine the total Physiologic points.

Variable Points: 26 13 12 11 9 7 6 5 4 3 2 0 1 2 3 4 6 7 9 10 12 15 16 18 40- 60- 70- 75- Age (years) <40 >80 59 69 74 79 Temperature (C) <39 >39 120 40- 70- >16 Heart Rate (bpm) <40 - 69 119 0 159 100 70- >20 Systolic BP (mmHg) <70 - 99 0 199 125 <12 >14 Serum Na (mEq/L) - 5 5 144 <3. 3.0- >5. Serum K (mEq/L) 0 4.9 0 15- HCO3 (mEq/L) <15 >20 19 28- BUN (mg/dL) <28 >84 83 1.0- WBC <1.0 19. >20 9 <4. 4.0- >6. Bilirubin (mg/dL) 0 5.9 0 <10 100- >20 PaO2/FiO2 0 199 0 9- 11- 14- GCS <6 6-8 10 13 15 Urine output (mL/d) <50 500 > 0 - 100 999 0 TOTAL SAPS-2 SCORE = Admission Type points + Chronic illness points + Physiologic points: ______APACHE II SCORE WORKSHEET Step 1: Calculate the total Acute Physiology Score Circle the appropriate range for the worst value within the first 24 hours prior to the first study IAP measurement.. Add the points determined for each physiological variable to determine the total Acute Physiology Score.

+4 +3 +2 +1 0 +1 +2 +3 +4 Rectal temp (C) >41 39-40.9 38.5-38.9 36-38.4 34-35.9 32-33.9 30-31.9 <29.9

Mean arterial pressure (mmHg) >160 130-159 110-129 70-109 50-69 <49

Heart rate (bpm) >180 140-179 110-139 70-109 55-69 40-54 <39

Respiratory rate (bpm) >50 35-49 25-34 12-24 10-11 6-9 <5 Oxygenation

If intubated and FiO2 ≥ 0.50, use AaDO2* >500 350-499 200-349 < 200

If intubated and FiO2 < 0.50, use PaO2 >70 61-70 55-60 <50

Arterial pH >7.7 7.6-7.69 7.5-7.59 7.3-7.49 7.25-7.3 7.15-7.24 < 7.15

Serum sodium (mmol/l) >180 160-179 155-159 150-154 130-149 120-129 111-119 <110

Serum potassium (mmol/l) >7 6-6.9 5.5-5.9 3.5-5.4 3-3.4 2.5-2.9 <2.5

Serum creatinine (mg/dl) >3.5 2-3.4 1.5-1.9 0.6-1.4 <0.6 (Double score for acute renal failure)

Haematocrit (%) >60 50-59.9 46-49.9 30-45.9 20-29.9 < 20

White cell count (103/ml) >40 20-39.9 15-19.9 3-14.9 1-2.9 < 1

Glascow Coma Score (GCS) Score = 15 minus actual GCS ______

Serum HCO3 (mmol/L) (only if no ABG) ≥ 52 41-51.9 32-40.9 22-31.9 18-21.9 15-17.9 < 15

* AaDO2 = (FiO2 x 713)-PaO2 – PaCO2

TOTAL ACUTE PHYSIOLOGY SCORE: ______APACHE II SCORE WORKSHEET (CONTINUED) APACHE II SCORE = SUM OF: Step 2: Determine the Age points from the table below I. Acute Physiology Score ______Age Points <44 0 II. Age points ______45-54 2 55-64 3 III. Chronic Health points ______65-74 5 >75 6 Total APACHE II Score ______Step 3: Calculate the Chronic Health points for each of the five organ systems Note: Organ insufficiency or immunocompromised state must have preceded the current admission.

History of severe organ insufficiency Points Non-operative patients 5 Emergency postoperative patients 5 Elective postoperative patients 2

A. Immunocompromised Score = ______D. Cardiovascular insufficiencyScore = ______ Receiving therapy that suppresses host defences (immunosuppression,  New York Heart Association Class IV chemotherapy, radiation therapy, long term steroid use, high dose steroid therapy) or E. Respiratory insufficiency Score = ______ Has a disease interfering with immune function such as malignant  Severe exercise restriction due to chronic restrictive, obstructive or lymphoma or leukaemia vascular disease,  Documented chronic hypoxia, hypercapnia, secondary B. Hepatic insufficiency Score = ______polycythaemia, severe pulmonary hypertension  Biopsy proven cirrhosis  Respirator dependency  Portal hypertension  Episodes of upper GI bleeding due to portal hypertension F. Renal insufficiency Score = ______ Prior episodes of hepatic failure, coma or encephalopathy  On chronic dialysis C. Measuring central venous pressure via femoral line:

After the decision has been made to insert a femoral venous central line, a strict aseptic technique conform with the departments standard policy of central venous access procedures should be applied. The zero point for the transducer is at the level of the right atrium in a supine patient; this phlebostatic axis is usually 5 cm caudal to the sternal notch on the midaxillary line. After zeroing, the pressure should be measured after approximately 30 seconds at end expiration.

The midchest reference point (phlebostatic axis) is located one half of the patient’s anteroposterior diameter below the sternal angle. Technique for IAP measurement IAP will be measured using the transvesical technique, after instillation of 20 mL of saline into the bladder, using an AbViser kit (Wolfe-Tory Medical, Salt Lake City, UT, USA), and connected to the monitoring equipment available in the unit. To standardize IAP measurement technique, Wolfe-Tory will provide the AbViser bladder monitoring kits to study sites that do not currently utilize this device free of charge.

Measurement Protocol - 1. With the AbViser device connected to the patient’s urinary catheter, place the patient in the supine position and make sure patients abdominal contractions are absent. 2. Zero the transducer at the level of iliac crest on the mid-axillary line (MARK WITH RULER for all subsequently measurements!!!!!!!!) 3. Instill 20 mL of sterile saline into the bladder (green diaphragm will automatically inflate to prevent the sterile saline to drain into the urine bag). 4. Wait 30 seconds and measure the IAP in mmHg at end-expiration. 5. Document the measured IAP in the appropriate box of the table. 6. Record the mean arterial pressure (which will give us the abdominal perfusion pressure). 7. Normally after approximately 1 minute the diaphragm (green) will deflate automatically to allow urine and saline to drain again into the urine bag. 8. Return the patient’s HOB to the position of choice in the study site ICU. 9. Subtract the volume of saline infused from the patient’s urinary output for that hour. STUDY DATA COLLECTION OVERVIEW

Study Entry Day one Day two Study Conclusion

Screening IAP time1 vs CVPtime1 IAP time1 vs CVPtime1 Outcome  Informed IAP time2 vs CVP time2 IAP time2 vs CVP time2 assessment consent OR IAP time3 vs CVP time3 IAP time3 vs CVP time3  Occurrence of Waiver of ACS at any time informed (total day 1, 6 (total day 2, 6  Need for consent measurements) measurements) decompression  Inclusion  Occurrence of checklist  RASS score  RASS score pulmonary  Exclusion  Temperature  Temperature aspiration checklist  PEEP level  PEEP level  Outcome at ICU  Mean arterial  Mean arterial discharge Baseline pressure pressure assessment  Abdomen status  Abdomen status  APACHE-II (open vs. closed) (open vs. losed) score  SOFA score  SAPS-2 score

Demographics  Age  Gender  Weight  Height  ICU admission diagnosis

IAH – Intra-Abdominal Hypertension, ACS – Abdominal Compartment Syndrome, HOB – head of bed, APACHE – Acute Physiology Chronic Health Evaluation, SOFA –Sequential Organ Failure Assessment, SAPS – Simplified Acute Physiology Score, RASS –Richmond Agitation Sedation Score, PEEP – positive end-expiratory pressure