Noninvasive Breathing Support for Severely Obese Patients
Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients
Recruiting
N/AInterventional Study
Obesity, MorbidExtubation Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
250 (estimated)
Sponsor
Rush University Medical Center · Other
Who this trial is looking for
This trial is looking for adults with severe obesity who are being taken off a breathing tube. Participants will receive noninvasive breathing support to see if it helps them breathe without needing the tube again.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years old or older
I have been on a breathing machine for at least 24 hours
I have a BMI of 40 or higher
I am scheduled to have the breathing tube removed
My blood pH levels are within acceptable ranges
You may not be able to join if
I am pregnant
I have a chronic tracheostomy
I accidentally had my breathing tube removed
I have a serious respiratory condition like COPD
I have a history of chronic respiratory failure requiring home support
My doctor believes I should not use noninvasive support
I or my family do not want reintubation if needed
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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Around 20% of the obese patients with higher body mass index (BMI) who are taken off the breathing tube and breathing machine (ventilator) end up needing it back to support breathing. The re-application of breathing tube is associated with poor outcomes, including high risk of pneumonia, longer hospital stays, and death. The purpose of this study is to assess if prophylactic use of noninvasive bre…
Around 20% of the obese patients with higher body mass index (BMI) who are taken off the breathing tube and breathing machine (ventilator) end up needing it back to support breathing. The re-application of breathing tube is associated with poor outcomes, including high risk of pneumonia, longer hospital stays, and death. The purpose of this study is to assess if prophylactic use of noninvasive breathing support after removing the breathing tube lowers the chance of needing the breathing tube again.
Trial Locations
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Eligibility Criteria
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. Pregn…
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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