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

April 7, 2026 updated by: Rennes University Hospital

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
441

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Amiens, France
        • CHU Amiens-Picardie
      • Brest, France
        • CHRU Brest
      • Dijon, France
        • CHU de Dijon
      • Nancy, France
        • CHU de Nancy
      • Poitiers, France
        • CHU Poitiers
      • Rennes, France
        • Chu Rennes
      • Rouen, France
        • CHU de Rouen
      • Saint-Herblain, France
        • CHU Nantes
      • Toulouse, France
        • CHU de Toulouse
      • Tours, France
        • Chru Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group_MRA
Recruitment maneuvers and high PEEP
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

Other Names:
  • recruitment maneuvers
Active Comparator: Control group
No recruitment maneuvers and low PEEP
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.
Other Names:
  • NO recruitment maneuvers

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of major pulmonary complications and death
Time Frame: 28 days after surgery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mortality rate
Time Frame: Day 28
Day 28
Evaluate the postoperative blood gases
Time Frame: 30 minutes after extubation
Measure of PaO2 (mmHg)
30 minutes after extubation
Evaluate the postoperative blood gases
Time Frame: 30 minutes after extubation
Measure of HCO3 (mmol/l)
30 minutes after extubation
Evaluate the postoperative blood gases
Time Frame: 30 minutes after extubation
Measure of PaCO2 (mmHg)
30 minutes after extubation
Evaluate the postoperative blood gases
Time Frame: 30 minutes after extubation
Measure of SaO2 (%)
30 minutes after extubation
Evaluate the postoperative blood gases
Time Frame: Day 1
Measure of PaO2 (mmHg)
Day 1
Evaluate the postoperative blood gases
Time Frame: Day 1
Measure of HCO3 (mmol/l)
Day 1
Evaluate the postoperative blood gases
Time Frame: Day 1
Measure of PaCO2 (mmHg)
Day 1
Evaluate the postoperative blood gases
Time Frame: Day 1
Measure of SaO2 (%)
Day 1
Evaluate the postoperative blood gases
Time Frame: Day 2
Measure of PaO2 (mmHg)
Day 2
Evaluate the postoperative blood gases
Time Frame: Day 2
Measure of HCO3 (mmol/l)
Day 2
Evaluate the postoperative blood gases
Time Frame: Day 2
Measure of PaCO2 (mmHg)
Day 2
Evaluate the postoperative blood gases
Time Frame: Day 2
Measure of SaO2 (%)
Day 2
Pulmonary function tests
Time Frame: Day 3
Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry
Day 3
Pulmonary function tests
Time Frame: Day 5
Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry
Day 5
Daily evaluation of organ failure
Time Frame: Up to 7 days
SOFA score
Up to 7 days
Daily evaluation of delirium
Time Frame: Up to 7 days
CAM-ICU scale
Up to 7 days
Rate of Postoperative pulmonary complications (PPC)
Time Frame: within the 28 days after surgery
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
Mortality rate
Time Frame: Day 90
Day 90
Mortality rate
Time Frame: Day 180
Day 180
Biomarkers of systemic inflammation and of epithelial and endothelial aggression
Time Frame: Day 0
Plasma levels of TNFα, IL1β, IL6, IL8 et IL10, Angiopoeitin 2 and soluble form of receptor for advanced glycation end products (sRAGE)
Day 0
Biomarkers of systemic inflammation and of epithelial and endothelial aggression
Time Frame: Day 1
Plasma levels of TNFα, IL1β, IL6, IL8 et IL10, Angiopoeitin 2 and soluble form of receptor for advanced glycation end products (sRAGE)
Day 1
Rate of patients with hypotension
Time Frame: intraoperative period
Safety criteria with Hypotension lasting more than 60 seconds after the end of the recruitment maneuvers
intraoperative period
Pulmonary function tests
Time Frame: Day -1 or Day 0
Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry
Day -1 or Day 0
Rate of Postoperative non pulmonary complications
Time Frame: within the 28 days after surgery
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 therapy
within the 28 days after surgery
Ventilation duration, length of stay in ICU and in the study hospital and death
Time Frame: Day 28
Number of Ventilatory-free days, vasopressor-free days, Renal Replacement Therapy free days, ICU-free days and hospital-free days
Day 28
Length of stay in ICU and in the study hospital
Time Frame: Day 180
Number of days in ICU and in the study hospital
Day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rennes University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nathalie DEMAURE, Chu Rennes
  • Principal Investigator: Nicolas NESSELER, MD, Chu Rennes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 8, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 16, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 16, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 35RC18_8854_VACARM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial will be available, after the primary publication of the results, to any researchers who provide a methodologically sound proposal. Proposals should be directed to dri@chu-rennes.fr. To gain access, data requestors will need to sign a data access agreement; depending on the case, additional formalities may be required.

IPD Sharing Time Frame

Data availability after the primary publication of the results and until the database is deleted

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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