Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a mask help avoid breathing tubes after surgery?

NCT ID NCT01971892

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether using a mask that helps with breathing (non-invasive ventilation) can prevent the need for a breathing tube in patients who develop respiratory failure after abdominal surgery. 300 adults who had abdominal surgery and then had trouble breathing were randomly assigned to receive either the mask or standard oxygen therapy. The main goal was to see if the mask reduced the number of patients needing a breathing tube within 7 days.

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) via facial mask
What this could lead to
If successful, this approach could reduce the need for breathing tubes and lower complications after abdominal surgery.
What could go wrong
This is a completed trial, but results may not apply to all patients or settings. NIV may not prevent intubation in severe cases.

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

300 people

The number who actually took part.

Start date

May 2013

Finished

Dec 2014

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: Eligibility : * age of more than 18 years * scheduled for elective or not elective abdominal surgery requiring laparotomy or laparoscopy and general anesthesia. Inclusion : * acute respiratory failure occurring within the seven days of the surgery procedure which is defined as presence and persistence for at least 30 min and at least one of the two followings: 1) a respiratory rate of more than 30 breaths per minute and 2) clinical signs suggestive of respiratory muscle fatigue, increased work of breathing, or both, such as use of respiratory accessory muscles, paradoxical motion of the abdomen, or retraction of intercostal spaces * hypoxemia defined by a PaO2 lower than 60 mmHg in ambient air or lower than 80 mmHg under 15 liters O2 or an arterial O2 saturation by pulse-oximetry (SpO2) lower than 90% (PaO2/FiO2\< 200 mmHg). Exclusion Criteria: * Emergency procedure surgery (operation that must be performed as soon as possible and no longer than 12 hours after inclusion in the study) * previous recruitment into another trial. * Cardiopulmonary arrest * Glasgow coma scale \<8 * Absence of airway protective gag reflex * Upper airway obstruction * Pregnancy. * Patients who refuse to undergo endotracheal intubation, whatever the initial therapeutic approach * Chronic home non invasive ventilation

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute respiratory failure are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Abdominal Injuries acute respiratory failure Hypoxia Postoperative Complications

As listed by the trial registrant

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

Acute respiratory failure Surgery Trauma to the abdomen

Contacts and locations

Locations

  • Department of Anesthesiology & Critical Care, St Eloi University Hospital

    Montpellier, 34000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.