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

NCT04408495 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 441

Last updated 2026-04-08

No results posted yet for this study

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

Conditions

  • Postoperative Pulmonary Complications

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.

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Nathalie DEMAURE · CHU Rennes

  • Nicolas NESSELER, MD · CHU Rennes

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-08
Primary Completion
2025-09-16
Completion
2025-09-16

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04408495 on ClinicalTrials.gov