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Heart surgery lung risk: which ventilation method wins?

NCT ID NCT04408495

Disease control Sponsor: Rennes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two ways of using a breathing machine during heart surgery in 441 high-risk patients. One method used higher air pressure and periodic deep breaths (recruitment maneuvers), while the other used lower pressure. The goal was to see which approach better prevents serious lung complications and death after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mechanical ventilation with high PEEP and recruitment maneuvers
What this could lead to
If successful, this could establish a safer ventilation method during heart surgery, reducing lung complications and deaths in high-risk patients.
What could go wrong
This is a completed trial, but results may not apply to all patients. The intervention could cause temporary drops in blood pressure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

441 people

The number who actually took part.

Started

Jul 2021

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Postoperative pulmonary complications

Contacts and locations

Locations

  • CHRU Brest

    Brest, France

  • CHRU Tours

    Tours, France

  • CHU Amiens-Picardie

    Amiens, France

  • CHU Nantes

    Saint-Herblain, France

  • CHU Poitiers

    Poitiers, France

  • CHU Rennes

    Rennes, France

  • CHU de Dijon

    Dijon, France

  • CHU de Nancy

    Nancy, France

  • CHU de Rouen

    Rouen, France

  • CHU de Toulouse

    Toulouse, France

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