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

N/AActive Not RecruitingNCT04408495

Rennes University Hospital440 enrolled

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

440

Conditions

Postoperative Pulmonary Complications

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

CHU Amiens-Picardie

Amiens, France

CHRU Brest

Brest, France

CHU de Dijon

Dijon, France

CHU de Nancy

Nancy, France

CHU Poitiers

Poitiers, France

CHU Rennes

Rennes, France

CHU de Rouen

Rouen, France

CHU Nantes

Saint-Herblain, France

CHU de Toulouse

Toulouse, France

CHRU Tours

Tours, France

Outcomes

Primary Outcomes

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

Time frame: 28 days after surgery

Secondary Outcomes

Rate of patients with hypotension

Safety criteria with Hypotension lasting more than 60 seconds after the end of the recruitment maneuvers

Time frame: intraoperative period