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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-08

Study Completion Date

2026-09-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Postoperative Pulmonary Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter, randomized, comparative, parallel-group trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group_MRA

Recruitment maneuvers and high PEEP

Group Type EXPERIMENTAL

Intervention group_MRA

Intervention Type PROCEDURE

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

No recruitment maneuvers and low PEEP

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type PROCEDURE

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.

Interventions

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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

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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recruitment maneuvers NO recruitment maneuvers

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No