Can new breathing methods keep obese patients off ventilators?
NCT ID NCT05918575
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
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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
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About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
5 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Central DuPage Hospital
NOT_YET_RECRUITINGWinfield, Illinois, 60190, United States
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Hospital Civil Fray Antonio Alcalde
RECRUITINGGuadalajara, Jalisco, 44280, Mexico
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McGovern Medical School, The University of Texas Health Science Center
RECRUITINGHouston, Texas, 77030, United States
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Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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Rush University Medical Center
RECRUITINGChicago, Illinois, 60612, United States
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