Intraoperative Mechanical Ventilation and Postoperative Pulmonary Complications After On-pump Cardiac Surgery in High-risk Patients (VACARM)

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

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pulmonary Complications
• Intervention / Treatment: Procedure: Intervention group_MRA; Procedure: Control group

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

• Study Type: Interventional
• Enrollment (Anticipated): 440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nathalie DEMAURE; Phone Number: 299284321; Email: nathalie.demaure@chu-rennes.fr
• Study Contact Backup: Name: Nicolas NESSELER, Dr; Email: nicolas.nesseler@chu-rennes.fr

Study Locations

• France
  • Amiens, France
    • Not yet recruiting
    • CHU Amiens-Picardie
    • Contact: Osama ABOU ARAB, Dr
  • Angers, France
    • Withdrawn
    • Chu Angers
  • Brest, France
    • Recruiting
    • CHRU Brest
    • Contact: Jean-Ferréol OILLEAU, Dr
  • Poitiers, France
    • Not yet recruiting
    • CHU Poitiers
    • Contact: Thomas KERFONE, Dr
  • Rennes, France
    • Recruiting
    • CHU Rennes
    • Contact: Nathalie DEMAURE
    • Principal Investigator: Nicolas NESSELER, Dr
    • Principal Investigator: Nathalie DEMAURE
  • Saint-Herblain, France
    • Recruiting
    • CHU Nantes
    • Contact: Bertrand ROZEC, Pr
  • Tours, France
    • Recruiting
    • CHRU Tours
    • Contact: Fabien ESPITALIER, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group_MRA; Recruitment maneuvers and high PEEP	Procedure: Intervention group_MRA; Tidal Volume (Vt) =6-8 mL/kg of predicted body weight (PBW), Peep=8 cmH2O, recruitment maneuvers=30cm H2O every 30 min after intubation (except during CPB), after any disconnection and at the admission in ICU. Recruitment maneuvers are performed in accordance with the surgical team an if SAP≥90 mmHg or MAP≥65 mmHg. Ventilation is maintained during CPB Vt=2.5 mL/kg, Peep= 5 cmH2O; Other Names: recruitment maneuvers
Active Comparator: Control group; No recruitment maneuvers and low PEEP	Procedure: Control group; Vt=6-8 mL/kg of PBW, Peep=5 cmH2O , No recruitment maneuvers. Ventilation maintained during CPB Vt=2.5 mL/kg, Peep= 5 cmH2O.; Other Names: NO recruitment maneuvers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of major pulmonary complications and death	Major pulmonary complications, defined as prolonged mechanical ventilation >24h post-operatively, pneumonia (defined according to the 2017 French guidelines) or reintubation for any cause within 7 post-operative days, or death	28 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rate		Day 28
Rate of patients with hypotension	Hypotension lasting more than 60 seconds after the end of the recruitment maneuvers	intraoperative period
Evaluate the postoperative blood gases	Measure of PaO2 (mmHg)	30 minutes after extubation
Evaluate the postoperative blood gases	Measure of HCO3 (mmol/l)	30 minutes after extubation
Evaluate the postoperative blood gases	Measure of PaCO2 (mmHg)	30 minutes after extubation
Evaluate the postoperative blood gases	Measure of SaO2 (%)	30 minutes after extubation
Evaluate the postoperative blood gases	Measure of PaO2 (mmHg)	Day 1
Evaluate the postoperative blood gases	Measure of HCO3 (mmol/l)	Day 1
Evaluate the postoperative blood gases	Measure of PaCO2 (mmHg)	Day 1
Evaluate the postoperative blood gases	Measure of SaO2 (%)	Day 1
Evaluate the postoperative blood gases	Measure of PaO2 (mmHg)	Day 2
Evaluate the postoperative blood gases	Measure of HCO3 (mmol/l)	Day 2
Evaluate the postoperative blood gases	Measure of PaCO2 (mmHg)	Day 2
Evaluate the postoperative blood gases	Measure of SaO2 (%)	Day 2
Pulmonary function tests	Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry	Day 0
Pulmonary function tests	Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry	Day 3
Pulmonary function tests	Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry	Day 5
Daily evaluation of organ failure	SOFA score	Up to 7 days
Daily evaluation of delirium	CAM-ICU scale	Up to 7 days
Rate of Postoperative pulmonary complications (PPC)	Pneumonia (defined according to the 2017 French guidelines), re-intubation within 7 days, mechanical ventilation >24h, pneumothorax, Atelectasis, Acute Respiratory Distress Syndrome. PPC grade (according to Huzelbos et al; JAMA)	within the 28 days after surgery
Rate of Postoperative non pulmonary complications	Re intervention for acute bleeding, Pericardial Tamponade, Sternal wound infection, Ventricular Arrhythmia, Atrial fibrillation, Myocardial infarction, Mesenteric ischemia, Sepsis/septic shock, Acute kidney injury with renal replacement	within the 28 days after surgery
Ventilation duration, length of stay in ICU and in the study hospital and death	Number of Ventilatory-free days, vasopressor-free days, ICU-free days and hospital-free days	Day 28
Mortality rate		Day 90
Mortality rate		Day 180
Biomarkers of systemic inflammation and of epithelial and endothelial aggression	Plasma levels of TNFα, IL1β, IL6, IL8 et IL10, Angiopoeitin 2 and soluble form of receptor for advanced glycation end products (sRAGE)	Day 0
Biomarkers of systemic inflammation and of epithelial and endothelial aggression	Plasma levels of TNFα, IL1β, IL6, IL8 et IL10, Angiopoeitin 2 and soluble form of receptor for advanced glycation end products (sRAGE)	Day 1

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Nathalie DEMAURE, CHU Rennes; Principal Investigator: Nicolas NESSELER, Dr, CHU Rennes; Principal Investigator: Jean-Ferréol OILLEAU, Dr, CHRU Brest; Principal Investigator: Emmanuelle LONGEAU, Dr, University Hospital, Angers; Principal Investigator: Bertrand ROZEC, Pr, CHU Nantes; Principal Investigator: Thomas KERFONE, Dr, CHU Poitiers; Principal Investigator: Fabien ESPITALIER, Dr, CHRU Tours; Principal Investigator: Osama ABOU ARAB, Dr, CHU Amiens-Picardie

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2021
• Primary Completion (Anticipated): August 8, 2025
• Study Completion (Anticipated): July 8, 2026

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 25, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Postoperative pulmonary complications; Mortality; Cardiac surgery; recruitment maneuvers; Peep
• Other Study ID Numbers: 35RC18_8854_VACARM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No