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Can new breathing methods keep obese patients off ventilators?

NCT ID NCT05918575

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Updated 2 times

Summary

About 20% of severely obese patients need their breathing tube reinserted after it's removed, which raises risks of pneumonia and longer hospital stays. This study tests whether using noninvasive breathing support (alternating between two devices) for 24 hours after tube removal can lower that risk. Researchers will enroll 250 adults with a BMI of 40 or higher who are ready to come off the ventilator.

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 and high flow nasal cannula
What this could lead to
If successful, this could provide a standard approach to prevent breathing tube reinsertion in severely obese patients after surgery or critical illness.
What could go wrong
This is a single-center trial with 250 participants, so results may not apply broadly. The interventions are supportive and not a cure for obesity or underlying conditions.

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

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

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: 1. Adult, age ≥ 18 years old 2. Receiving invasive mechanical ventilation for ≥24 hours 3. BMI ≥40 kg/m2 4. Undergoing planned extubation per treating team 5. Arterial pH ≥7.35 or venous pH ≥ 7.31 within 30 mins of spontaneous breathing trial (SBT) Exclusion Criteria: 1. Pregnant 2. Use of extra-corporeal membrane oxygenation 3. Chronic tracheostomy in place 4. Unplanned or accidental extubation 5. Terminal/compassionate extubation 6. Contraindication to NIV use 7. Intubated because of an acute exacerbation of COPD 8. Underlying neuromuscular disease 9. No reintubation requested by patient/family 10. Documented/known history of chronic hypercapnic respiratory failure on home NIV (including bilevel PAP). 11. Enrolled in any other outcome study 12. Treating clinician feels that HFNC or NIV are either mandatory or contraindicated for a given patient

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Central DuPage Hospital

    NOT_YET_RECRUITING

    Winfield, Illinois, 60190, United States

  • Hospital Civil Fray Antonio Alcalde

    RECRUITING

    Guadalajara, Jalisco, 44280, Mexico

  • McGovern Medical School, The University of Texas Health Science Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

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