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Can a breathing mask after surgery save lungs? new trial investigates

NCT ID NCT03629431

Prevention Sponsor: Institut Cancerologie de l'Ouest 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether giving patients non-invasive ventilation (a mask that helps them breathe) soon after surgery could prevent serious lung complications. It included 266 adults at high risk (based on a score called ARISCAT) who were having surgery under general or regional anesthesia. Half received the breathing support in the ICU for at least 24 hours, while the other half got standard post-surgery care. The goal was to see if the mask treatment reduced the need for a breathing tube or ventilator within the first week.

What this could mean

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

Active substance
non-invasive ventilation (breathing support via mask)
What this could lead to
If it works, this could lead to a standard preventive breathing treatment for patients at high risk of lung problems after surgery.
What could go wrong
This trial is completed but results are not yet widely adopted. The benefit may be small or limited to certain patients, and the treatment requires intensive care monitoring.

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

266 people

The number who actually took part.

Started

Nov 2017

Finished

Oct 2019

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: * Patient 18 years of age or older * Patient scheduled for surgery or considered semi-urgent (=pre-anesthesia consultation \<48h before the surgical procedure) under General Anesthesia or under Loco-Regional Anesthesia * Patient with an ARISCAT score higher than or equal to 45 - Obtaining the signed written consent of the patient * Patient affiliated to a social security scheme Exclusion Criteria: * Minor patients, pregnant or lactating women * Obstetrical interventions * Surgery under Local Anesthesia or Peripheral Nerve, * Interventions taking place outside an interventional room * Interventions for previous surgical complications * Second surgery during study * Organ transplantation * Patients already intubated in preoperative * Outpatient surgery * Refusal of participation or inability to issue informed consent * Person deprived of liberty or adult under guardianship * Participation in another interventional study

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As listed by the trial registrant

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

Pulmonary complication Surgical patients

Contacts and locations

Locations

  • Ch Du Mans

    Le Mans, 72037, France

  • Chu D'Angers

    Angers, 49000, France

  • Institut de Cancerologie de L'Ouest

    Angers, 49000, France

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