Clinical trial NCT04408495: Intraoperative Mechanical Ventilation and Postoperative Pulmonary Complications After On-pump Cardiac Surgery in High-risk Patients
Official title: Effect of IntraoperatiVe High Positive End-ExpirAtory Pressure (PEEP) With ReCruitment MAneuveRs vs Low PEEP on Major Postoperative Pulmonary Complications and Death After On-pump Cardiac Surgery in High-risk Patients: the VACARM Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pulmonary Complications
Keywords: recruitment maneuvers
Postoperative pulmonary complications
Peep
Cardiac surgery
Mortality
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, randomized, comparative, parallel-group trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Controversies remain concerning the best intraoperative mechanical ventilation regimen for major cardiac surgery. While the use of intra operative low tidal volumes is now standard practice, the optimal level of positive end-expiratory pressure (PEEP) and the use of recruitment maneuvers (RM) remain controversial. The aim of this study is to compare two regimens of intraoperative mechanical ventilation on postoperative outcomes in cardiac surgery patients at risk of postoperative pulmonary complications

Detailed description: In this randomized controlled trial, cardiac surgery patients at risk of postoperative pulmonary complications will be assigned to intraoperative ventilation with high PEEP and RM or intraoperative mechanical ventilation with low PEEP and without RM. The primary endpoint will be a composite endpoint including major postoperative complications within the first postoperative week and death within the 28 days after surgery

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years-old,
* Evaluated before cardiopulmonary bypass for any cardiac surgical procedure (e.g. coronary artery bypass grafting, valve, aorta, or combined procedures),
* With a pulmonary risk score ≥ 2
* Who gave written informed consent
* affiliated to a social security system

Exclusion Criteria:

* BMI \> 40kg/m2 ;
* Left Ventricular Ejection Fraction \< 35% ;
* Preoperative shock ;
* Aortic surgery with planned circulatory arrest ;
* Minimally invasive cardiac surgery ;
* Emergency surgery with patient unable to give written informed consent
* Heart transplantation
* Mechanical circulatory support surgery
* Pregnant or lactating women
* Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty

Primary outcomes:
measure: Rate of major pulmonary complications and death
timeFrame: 28 days after surgery
Secondary outcomes:
measure: Rate of patients with hypotension
timeFrame: intraoperative period
measure: Evaluate the postoperative blood gases
timeFrame: 30 minutes after extubation
measure: Evaluate the postoperative blood gases
timeFrame: 30 minutes after extubation
measure: Evaluate the postoperative blood gases
timeFrame: 30 minutes after extubation
measure: Evaluate the postoperative blood gases
timeFrame: 30 minutes after extubation
measure: Evaluate the postoperative blood gases
timeFrame: Day 1
measure: Evaluate the postoperative blood gases
timeFrame: Day 1
measure: Evaluate the postoperative blood gases
timeFrame: Day 1
measure: Evaluate the postoperative blood gases
timeFrame: Day 1
measure: Evaluate the postoperative blood gases
timeFrame: Day 2
measure: Evaluate the postoperative blood gases
timeFrame: Day 2
measure: Evaluate the postoperative blood gases
timeFrame: Day 2
measure: Evaluate the postoperative blood gases
timeFrame: Day 2
measure: Pulmonary function tests
timeFrame: Day 0
measure: Pulmonary function tests
timeFrame: Day 3
measure: Pulmonary function tests
timeFrame: Day 5
measure: Daily evaluation of organ failure
timeFrame: Up to 7 days
measure: Daily evaluation of delirium
timeFrame: Up to 7 days
measure: Rate of Postoperative pulmonary complications (PPC)
timeFrame: within the 28 days after surgery
measure: Rate of Postoperative non pulmonary complications
timeFrame: within the 28 days after surgery
measure: Ventilation duration, length of stay in ICU and in the study hospital and death
timeFrame: Day 28
measure: Mortality rate
timeFrame: Day 28
measure: Mortality rate
timeFrame: Day 90
measure: Mortality rate
timeFrame: Day 180
measure: Biomarkers of systemic inflammation and of epithelial and endothelial aggression
timeFrame: Day 0
measure: Biomarkers of systemic inflammation and of epithelial and endothelial aggression
timeFrame: Day 1
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
city: Brest
country: France
facility: CHRU Brest
city: Dijon
country: France
facility: CHU de Dijon
city: Nancy
country: France
facility: CHU de Nancy
city: Poitiers
country: France
facility: CHU Poitiers
city: Rennes
country: France
facility: CHU Rennes
city: Rouen
country: France
facility: CHU de Rouen
city: Saint-Herblain
country: France
facility: CHU Nantes
city: Toulouse
country: France
facility: CHU de Toulouse
city: Tours
country: France
facility: CHRU Tours
Study officials:
affiliation: CHU Rennes
name: Nathalie DEMAURE
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rennes
name: Nicolas NESSELER, MD
role: PRINCIPAL_INVESTIGATOR
References: