Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05918575

Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients

Led by Rush University Medical Center · Updated on 2025-10-20

250

Participants Needed

5

Research Sites

177 weeks

Total Duration

On this page

Sponsors

R

Rush University Medical Center

Lead Sponsor

H

Hospital Civil de Guadalajara

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Receiving invasive mechanical ventilation for 24 hours or more
  • Body mass index (BMI) of 40 kg/m2 or higher
  • Undergoing planned removal of the breathing tube (extubation) as decided by your treatment team
  • Arterial pH of 7.35 or higher, or venous pH of 7.31 or higher within 30 minutes of spontaneous breathing trial
Not Eligible

You will not qualify if you...

  • Pregnant
  • Use of extracorporeal membrane oxygenation (ECMO)
  • Presence of a chronic tracheostomy
  • Unplanned or accidental removal of the breathing tube
  • Terminal or compassionate extubation
  • Contraindications to using noninvasive ventilation (NIV)
  • Intubation due to acute exacerbation of chronic obstructive pulmonary disease (COPD)
  • Underlying neuromuscular disease
  • Patient or family requested no reintubation
  • History of chronic hypercapnic respiratory failure requiring home NIV
  • Currently enrolled in another outcome study
  • Treating clinician considers HFNC or NIV mandatory or contraindicated for the patient

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Rush University Medical Center

Chicago, Illinois, United States, 60612

Actively Recruiting

2

Central DuPage Hospital

Winfield, Illinois, United States, 60190

Not Yet Recruiting

3

McGovern Medical School, The University of Texas Health Science Center

Houston, Texas, United States, 77030

Actively Recruiting

4

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

5

Hospital Civil Fray Antonio Alcalde

Guadalajara, Jalisco, Mexico, 44280

Actively Recruiting

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Research Team

R

Ramandeep Kaur, PhD

CONTACT

B

Babak Mokhlesi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients | DecenTrialz