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Can a mask help patients escape the breathing tube faster?

NCT ID NCT00213499

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study looked at whether using a noninvasive ventilation mask (NIV) can help patients with chronic respiratory failure wean off mechanical ventilation more successfully. 205 patients who had been on a breathing tube for at least 48 hours and failed a spontaneous breathing test were randomly assigned to one of three weaning strategies: continued invasive ventilation, extubation with oxygen, or extubation with NIV. The goal was to see which approach led to the highest weaning success rate and fewer complications.

What this could mean

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

Active substance
noninvasive ventilation (NIV)
What this could lead to
If successful, this could establish NIV as a standard method to help patients with chronic respiratory failure get off breathing machines more quickly and safely.
What could go wrong
This trial is completed and results may not apply to all patients. NIV may not work for everyone and could delay necessary reintubation in some 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

205 people

Start date

Jan 2002

Finished

Sep 2008

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: * endotracheal mechanical ventilation for 48 hours or more for acute respiratory failure in chronic respiratory failure patients (obstructive or restrictive disease), * patient ready to be weaned (steady respiratory and hemodynamic conditions for 24 hours), * spontaneous breathing trial failure occurring between 5 minutes and 2 hours, judged on clinical and/or arterial blood gas tolerance, * written informed consent obtained (patient or family) Exclusion Criteria: * respiratory and hemodynamic instability * initial intubation considered as difficult * swallowing disorders suspected * inefficient cough * bronchial hypersecretion at the weaning time * non cooperant patient * contra-indications for nasal or facial mask (facial skin lesions,...) * recent history of upper gastro-intestinal surgery * recent history of myocardial infarction

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Conditions

The condition(s) this trial relates to.

respiratory failure

As listed by the trial registrant

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

Chronic respiratory failure Weaning

Contacts and locations

Locations

  • Rouen University Charles Nicolle Hospital

    Rouen, 76031, France

More trials for these conditions

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