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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 8, 2025

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

Interventions

  • 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
  • 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.

Arms, Groups and Cohorts

  • Experimental: Intervention group_MRA
    • Recruitment maneuvers and high PEEP
  • Active Comparator: Control group
    • No recruitment maneuvers and low PEEP

Clinical Trial Outcome Measures

Primary Measures

  • Rate of major pulmonary complications and death
    • Time Frame: 28 days after surgery
    • 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

Secondary Measures

  • Rate of patients with hypotension
    • Time Frame: intraoperative period
    • Hypotension lasting more than 60 seconds after the end of the recruitment maneuvers
  • Evaluate the postoperative blood gases
    • Time Frame: 30 minutes after extubation
    • Measure of PaO2 (mmHg)
  • Evaluate the postoperative blood gases
    • Time Frame: 30 minutes after extubation
    • Measure of HCO3 (mmol/l)
  • Evaluate the postoperative blood gases
    • Time Frame: 30 minutes after extubation
    • Measure of PaCO2 (mmHg)
  • Evaluate the postoperative blood gases
    • Time Frame: 30 minutes after extubation
    • Measure of SaO2 (%)
  • Evaluate the postoperative blood gases
    • Time Frame: Day 1
    • Measure of PaO2 (mmHg)
  • Evaluate the postoperative blood gases
    • Time Frame: Day 1
    • Measure of HCO3 (mmol/l)
  • Evaluate the postoperative blood gases
    • Time Frame: Day 1
    • Measure of PaCO2 (mmHg)
  • Evaluate the postoperative blood gases
    • Time Frame: Day 1
    • Measure of SaO2 (%)
  • Evaluate the postoperative blood gases
    • Time Frame: Day 2
    • Measure of PaO2 (mmHg)
  • Evaluate the postoperative blood gases
    • Time Frame: Day 2
    • Measure of HCO3 (mmol/l)
  • Evaluate the postoperative blood gases
    • Time Frame: Day 2
    • Measure of PaCO2 (mmHg)
  • Evaluate the postoperative blood gases
    • Time Frame: Day 2
    • Measure of SaO2 (%)
  • Pulmonary function tests
    • Time Frame: Day 0
    • Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry
  • Pulmonary function tests
    • Time Frame: Day 3
    • Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry
  • Pulmonary function tests
    • Time Frame: Day 5
    • Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry
  • Daily evaluation of organ failure
    • Time Frame: Up to 7 days
    • SOFA score
  • Daily evaluation of delirium
    • Time Frame: Up to 7 days
    • CAM-ICU scale
  • Rate of Postoperative pulmonary complications (PPC)
    • Time Frame: within the 28 days after surgery
    • 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)
  • Rate of Postoperative non pulmonary complications
    • Time Frame: within the 28 days after surgery
    • 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
  • Ventilation duration, length of stay in ICU and in the study hospital and death
    • Time Frame: Day 28
    • Number of Ventilatory-free days, vasopressor-free days, ICU-free days and hospital-free days
  • Mortality rate
    • Time Frame: Day 28
  • Mortality rate
    • Time Frame: Day 90
  • Mortality rate
    • Time Frame: Day 180
  • Biomarkers of systemic inflammation and of epithelial and endothelial aggression
    • Time Frame: Day 0
    • Plasma levels of TNFα, IL1β, IL6, IL8 et IL10, Angiopoeitin 2 and soluble form of receptor for advanced glycation end products (sRAGE)
  • Biomarkers of systemic inflammation and of epithelial and endothelial aggression
    • Time Frame: Day 1
    • Plasma levels of TNFα, IL1β, IL6, IL8 et IL10, Angiopoeitin 2 and soluble form of receptor for advanced glycation end products (sRAGE)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rennes University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nathalie DEMAURE, Principal Investigator, CHU Rennes
    • Nicolas NESSELER, Dr, Principal Investigator, CHU Rennes
    • Jean-Ferréol OILLEAU, Dr, Principal Investigator, CHRU Brest
    • Emmanuelle LONGEAU, Dr, Principal Investigator, University Hospital, Angers
    • Bertrand ROZEC, Pr, Principal Investigator, Nantes University Hospital
    • Thomas KERFONE, Dr, Principal Investigator, CHU Poitiers
    • Fabien ESPITALIER, Dr, Principal Investigator, CHRU Tours
    • Osama ABOU ARAB, Dr, Principal Investigator, CHU Amiens-Picardie
  • Overall Contact(s)
    • Nathalie DEMAURE, 299284321, nathalie.demaure@chu-rennes.fr

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