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NCT05918575Recruiting

Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients

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

Source: ClinicalTrials.gov · Last updated 7 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
250 (estimated)
First submitted
15 Jun 2023
Start date
10 Jul 2023
Primary completion date
1 Jul 2028
Lead sponsor
Rush University Medical Center
Diseases
Obesity
NCT number
NCT05918575

What you commit to

  • Study type: Interventional
  • Planned participants: 250
  • From 10 Jul 2023 to the primary completion date, 1 Jul 2028
  • 5 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Underlying neuromuscular disease
  • Documented/known history of chronic hypercapnic respiratory failure on home NIV (including bilevel PAP).

Other

  • Pregnant
  • Use of extra-corporeal membrane oxygenation
  • Chronic tracheostomy in place
  • Unplanned or accidental extubation
  • Terminal/compassionate extubation
  • Contraindication to NIV use
  • Intubated because of an acute exacerbation of COPD
  • No reintubation requested by patient/family
  • Enrolled in any other outcome study
  • Treating clinician feels that HFNC or NIV are either mandatory or contraindicated for a given patient

Who the study is looking for

  • Adult, age ≥ 18 years old
  • Receiving invasive mechanical ventilation for ≥24 hours
  • BMI ≥40 kg/m2
  • Undergoing planned extubation per treating team
  • Arterial pH ≥7.35 or venous pH ≥ 7.31 within 30 mins of spontaneous breathing trial (SBT)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Civil Fray Antonio Alcalde
Coordinator of this site? Confirm its status
GuadalajaraMexicoRecruiting
Rush University Medical Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
McGovern Medical School, The University of Texas Health Science Center
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Medical College of Wisconsin
Coordinator of this site? Confirm its status
MilwaukeeUnited StatesRecruiting
Central DuPage Hospital
Coordinator of this site? Confirm its status
WinfieldUnited StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.