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Can a mask prevent breathing failure in obese ICU patients?

NCT ID NCT04014920

Disease control Sponsor: University Hospital, Montpellier 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether using a non-invasive ventilation (NIV) mask right after removing a breathing tube can prevent respiratory failure in obese intensive care patients. About 1000 obese adults were randomly assigned to receive either NIV or oxygen therapy. The goal was to see which approach reduces the need for re-intubation or other breathing support failures.

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 (NIV) and oxygen therapy (high-flow nasal oxygen or standard oxygen)
What this could lead to
If NIV proves superior, it could become the standard post-extubation care for obese ICU patients, reducing the need for re-intubation.
What could go wrong
This is a completed trial, but results may not apply to all obese patients or settings. NIV can cause discomfort or skin damage, and some patients may still need re-intubation.

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

1,000 people

The number who actually took part.

Started

Oct 2019

Finished

Oct 2021

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: * Adult (age ≥ 18 years) * Subjects must be covered by public health insurance * Obese patients defined by a body mass index ≥ 30 kg/m² * Extubation after a length of mechanical ventilation \>= 6 hours * Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency. Exclusion Criteria: * Refusal of study participation or to pursue the study by the patient * Hypercapnia with a formal indication for NIV (PaCO2 ≥ 50 mmHg, formal indication for NIV) * Isolated cardiogenic pulmonary edema (formal indication for NIV). Patients with pulmonary edema associated with another ARF etiology can be included. * Pregnancy or breastfeeding * Anatomical factors precluding the use of NIV and/or HFNO * Absence of coverage by the French statutory healthcare insurance system * Patients with tracheostomy * Patients with CPAP for obstructive apnea syndrome * Patients with decision of no-reintubate (limitation)

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Respiratory Aspiration ventilation pneumonitis acute respiratory failure prevention target

As listed by the trial registrant

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

Intensive care unit Obesity Ventilation

Contacts and locations

Locations

  • Centre Hospitalier Universitaire Saint Eloi

    Montpellier, Herault, 34000, France

More trials for these conditions

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