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Postoperative Pulmonary ComplicationsVACARMNCT04408495

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

A study testing Intervention group_MRA in people with Postoperative Pulmonary Complications, run by Rennes University Hospital at 10 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Postoperative Pulmonary Complications
What is being tested?
Intervention group_MRA
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
441 participants
Where
10 sitesFrance
Study dates
8 Jul 2021to 16 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Heart transplantation
  • Mechanical circulatory support surgery
  • Pregnant or lactating women
  • Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

France10 sites

  • CHU Amiens-Picardie

    Amiens

  • CHRU Brest

    Brest

  • CHU de Dijon

    Dijon

  • CHU de Nancy

    Nancy

  • CHU Poitiers

    Poitiers

  • CHU Rennes

    Rennes

  • CHU de Rouen

    Rouen

  • CHU Nantes

    Saint-Herblain

  • CHU de Toulouse

    Toulouse

  • CHRU Tours

    Tours

Other trials in France

About this study

Official title: 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

Read the 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

Being tested
Intervention group_MRA, Control group
Keywords
recruitment maneuvers, Postoperative pulmonary complications, Peep, Cardiac surgery, Mortality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention group_MRAProcedure or surgery

    Also called recruitment maneuvers

    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 groupProcedure or surgery

    Also called NO recruitment maneuvers

    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.

Study groups in NCT04408495
Study groupRoleWhat they receive
Intervention group_MRAExperimentalRecruitment maneuvers and high PEEP
Receives: Procedure: Intervention group_MRA
Control groupActive comparatorNo recruitment maneuvers and low PEEP
Receives: Procedure: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 28 days after surgery

Secondary outcomes (27)

  1. Rate of patients with hypotension

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

    Measured: intraoperative period

  2. Evaluate the postoperative blood gases

    Measure of PaO2 (mmHg)

    Measured: 30 minutes after extubation

  3. Evaluate the postoperative blood gases

    Measure of HCO3 (mmol/l)

    Measured: 30 minutes after extubation

  4. Evaluate the postoperative blood gases

    Measure of PaCO2 (mmHg)

    Measured: 30 minutes after extubation

  5. Evaluate the postoperative blood gases

    Measure of SaO2 (%)

    Measured: 30 minutes after extubation

  6. Evaluate the postoperative blood gases

    Measure of PaO2 (mmHg)

    Measured: Day 1

  7. Evaluate the postoperative blood gases

    Measure of HCO3 (mmol/l)

    Measured: Day 1

  8. Evaluate the postoperative blood gases

    Measure of PaCO2 (mmHg)

    Measured: Day 1

  9. Evaluate the postoperative blood gases

    Measure of SaO2 (%)

    Measured: Day 1

  10. Evaluate the postoperative blood gases

    Measure of PaO2 (mmHg)

    Measured: Day 2

  11. Evaluate the postoperative blood gases

    Measure of HCO3 (mmol/l)

    Measured: Day 2

  12. Evaluate the postoperative blood gases

    Measure of PaCO2 (mmHg)

    Measured: Day 2

  13. Evaluate the postoperative blood gases

    Measure of SaO2 (%)

    Measured: Day 2

  14. Pulmonary function tests

    Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry

    Measured: Day -1 or Day 0

  15. Pulmonary function tests

    Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry

    Measured: Day 3

  16. Pulmonary function tests

    Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry

    Measured: Day 5

  17. Daily evaluation of organ failure

    SOFA score

    Measured: Up to 7 days

  18. Daily evaluation of delirium

    CAM-ICU scale

    Measured: Up to 7 days

  19. Rate of Postoperative pulmonary complications (PPC)

    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)

    Measured: within the 28 days after surgery

  20. Rate of Postoperative non pulmonary complications

    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

    Measured: within the 28 days after surgery

  21. Ventilation duration, length of stay in ICU and in the study hospital and death

    Number of Ventilatory-free days, vasopressor-free days, Renal Replacement Therapy free days, ICU-free days and hospital-free days

    Measured: Day 28

  22. Mortality rate

    Measured: Day 28

  23. Mortality rate

    Measured: Day 90

  24. Mortality rate

    Measured: Day 180

  25. Biomarkers of systemic inflammation and of epithelial and endothelial aggression

    Plasma levels of TNFα, IL1β, IL6, IL8 et IL10, Angiopoeitin 2 and soluble form of receptor for advanced glycation end products (sRAGE)

    Measured: Day 0

  26. Biomarkers of systemic inflammation and of epithelial and endothelial aggression

    Plasma levels of TNFα, IL1β, IL6, IL8 et IL10, Angiopoeitin 2 and soluble form of receptor for advanced glycation end products (sRAGE)

    Measured: Day 1

  27. Length of stay in ICU and in the study hospital

    Number of days in ICU and in the study hospital

    Measured: Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2020
  2. Study start8 Jul 2021
  3. Primary completion16 Sep 2025
  4. Study completion16 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter, randomized, comparative, parallel-group trial
Masking
None (open label)
Enrolment
441 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04408495
Sponsor's protocol ID
35RC18_8854_VACARM
Acronym
VACARM
Status last verified
Apr 2026
First submitted
15 May 2020
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 41161829

Questions about this trial

What is this clinical trial studying?

A study testing Intervention group_MRA in people with Postoperative Pulmonary Complications, run by Rennes University Hospital at 10 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of major pulmonary complications and death (time frame: 28 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04408495, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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