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

Postoperative Pulmonary Complications Clinical Trial

— VACARM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04408495
• Other study ID #: 35RC18_8854_VACARM
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2021
• Est. completion date: July 8, 2026

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: Nathalie DEMAURE
• Phone: 299284321
• Email: nathalie.demaure[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: July 8, 2026
• Est. primary completion date: August 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Pulmonary Complications

Intervention

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
• 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.

Locations

Country	Name	City	State
France	CHU Amiens-Picardie	Amiens
France	CHU Angers	Angers
France	CHRU Brest	Brest
France	CHU Poitiers	Poitiers
France	CHU Rennes	Rennes
France	CHU Nantes	Saint-Herblain
France	CHRU Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of patients with hypotension	Hypotension lasting more than 60 seconds after the end of the recruitment maneuvers	intraoperative period
Secondary	Evaluate the postoperative blood gases	Measure of PaO2 (mmHg)	30 minutes after extubation
Secondary	Evaluate the postoperative blood gases	Measure of HCO3 (mmol/l)	30 minutes after extubation
Secondary	Evaluate the postoperative blood gases	Measure of PaCO2 (mmHg)	30 minutes after extubation
Secondary	Evaluate the postoperative blood gases	Measure of SaO2 (%)	30 minutes after extubation
Secondary	Evaluate the postoperative blood gases	Measure of PaO2 (mmHg)	Day 1
Secondary	Evaluate the postoperative blood gases	Measure of HCO3 (mmol/l)	Day 1
Secondary	Evaluate the postoperative blood gases	Measure of PaCO2 (mmHg)	Day 1
Secondary	Evaluate the postoperative blood gases	Measure of SaO2 (%)	Day 1
Secondary	Evaluate the postoperative blood gases	Measure of PaO2 (mmHg)	Day 2
Secondary	Evaluate the postoperative blood gases	Measure of HCO3 (mmol/l)	Day 2
Secondary	Evaluate the postoperative blood gases	Measure of PaCO2 (mmHg)	Day 2
Secondary	Evaluate the postoperative blood gases	Measure of SaO2 (%)	Day 2
Secondary	Pulmonary function tests	Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry	Day 0
Secondary	Pulmonary function tests	Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry	Day 3
Secondary	Pulmonary function tests	Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry	Day 5
Secondary	Daily evaluation of organ failure	SOFA score	Up to 7 days
Secondary	Daily evaluation of delirium	CAM-ICU scale	Up to 7 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Mortality rate		Day 28
Secondary	Mortality rate		Day 90
Secondary	Mortality rate		Day 180
Secondary	Biomarkers of systemic inflammation and of epithelial and endothelial aggression	Plasma levels of TNFa, IL1ß, IL6, IL8 et IL10, Angiopoeitin 2 and soluble form of receptor for advanced glycation end products (sRAGE)	Day 0
Secondary	Biomarkers of systemic inflammation and of epithelial and endothelial aggression	Plasma levels of TNFa, IL1ß, IL6, IL8 et IL10, Angiopoeitin 2 and soluble form of receptor for advanced glycation end products (sRAGE)	Day 1