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

NCT04408495 | Completed

• 1 other identifier: 35RC18_8854_VACARM
• Study Type: interventional
• Target: 441
• Locations: 1 country
• Sites: 10

Brief 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

Keywords

recruitment maneuvers; Postoperative pulmonary complications; Peep; Cardiac surgery; Mortality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (27)

• Rate of patients with hypotension

  intraoperative period

• Evaluate the postoperative blood gases

  30 minutes after extubation

• Evaluate the postoperative blood gases

  30 minutes after extubation

• Evaluate the postoperative blood gases

  30 minutes after extubation

• Evaluate the postoperative blood gases

  30 minutes after extubation

Study Arms (2)

Intervention group_MRA

EXPERIMENTAL

Recruitment maneuvers and high PEEP

Procedure: Intervention group_MRA

Control group

ACTIVE COMPARATOR

No recruitment maneuvers and low PEEP

Procedure: Control group

Interventions

Intervention group_MRA 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

Also known as: recruitment maneuvers

Intervention group_MRA

Control group 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.

Also known as: NO recruitment maneuvers

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (10)

CHU Amiens-Picardie

Amiens, France

Location

CHRU Brest

Brest, France

Location

CHU de Dijon

Dijon, France

Location

CHU de Nancy

Nancy, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Rennes

Rennes, France

Location

CHU de Rouen

Rouen, France

Location

CHU Nantes

Saint-Herblain, France

Location

CHU de Toulouse

Toulouse, France

Location

CHRU Tours

Tours, France

Location

Related Publications (1)

• Demaure N, Le Cunff J, Duchene M, Rozec B, Espitalier F, Cabon JM, Oilleau JF, Guerci P, Labaste F, Abou-Arab O, Guinot PG, Duval P, Besnier E, Flecher E, Leroyer I, Morcet J, Fougerou-Leurent C, Mansour A, Nesseler N; VACARM investigators; ATLANREA study group. Impact of intraoperatiVe moderAte positive end-expiratory pressure with reCruitment mAnoeuvres versus low positive end-expiRatory pressure on major postoperative pulMonary complications and death after on-pump cardiac surgery in high-risk patients: the VACARM randomised clinical trial-study protocol. BMJ Open. 2025 Oct 29;15(10):e104179. doi: 10.1136/bmjopen-2025-104179.

  PMID: 41161829 DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Nathalie DEMAURE

  CHU Rennes

  PRINCIPAL INVESTIGATOR

• Nicolas NESSELER, MD

  CHU Rennes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized, comparative, parallel-group trial

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 29, 2020
• Study Start: July 8, 2021
• Primary Completion: September 16, 2025
• Study Completion: September 16, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data availability after the primary publication of the results and until the database is deleted
• Access Criteria: Any researchers who provide a methodologically sound proposal will be able to access the IPD ans supporting information. To gain access, data requestors will need to sign a data access agreement; depending on the case, additional formalities may be required.

Locations

FR (10)