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Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients

Recruiting

A Randomized Controlled Trial of Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients

Who can join

Ages 18 and older · All sexes

Full 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. 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

About the study

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.

What is being tested

Noninvasive ventilation alternating with high flow nasal cannula (device)
High flow nasal cannula (device)

Sponsor: Rush University Medical Center · Participants: 250 · Started: Jul 10, 2023

Contact the study team

Ramandeep Kaur, PhD · Phone: 3129478898
Babak Mokhlesi, MD · Phone: (312) 563-0843

Official record on ClinicalTrials.gov — NCT05918575

Locations in the U.S.

Illinois	Rush University Medical Center, Chicago Central DuPage Hospital, Winfield (Not yet recruiting)
Texas	McGovern Medical School, The University of Texas Health Science Center, Houston
Wisconsin	Medical College of Wisconsin, Milwaukee

Conditions

Weight Loss Surgery

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.