RECRUITING

Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-07-10
Study Completion:2026-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05918575

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult, age ≥ 18 years old
  2. 2. Receiving invasive mechanical ventilation for ≥24 hours
  3. 3. BMI ≥40 kg/m2
  4. 4. Undergoing planned extubation per treating team
  5. 5. Arterial pH ≥7.35 or venous pH ≥ 7.31 within 30 mins of spontaneous breathing trial (SBT)
  1. 1. Pregnant
  2. 2. Use of extra-corporeal membrane oxygenation
  3. 3. Chronic tracheostomy in place
  4. 4. Unplanned or accidental extubation
  5. 5. Terminal/compassionate extubation
  6. 6. Contraindication to NIV use
  7. 7. Intubated for neurological reasons or for airway protection (stroke, intracerebral hemorrhage, intraventricular hemorrhage)
  8. 8. Intubated because of an acute exacerbation of COPD
  9. 9. Underlying neuromuscular disease
  10. 10. No reintubation requested by patient/family
  11. 11. Documented/known history of chronic hypercapnic respiratory failure on home NIV (including bilevel PAP).
  12. 12. Enrolled in any other outcome study
  13. 13. Treating clinician feels that HFNC or NIV are either mandatory or contraindicated for a given patient

Contacts and Locations

Study Contact

Ramandeep Kaur, PhD
CONTACT
3129478898
ramandeep_kaur@rush.edu
Babak Mokhlesi, MD
CONTACT
(312) 563-0843
babak_mokhlesi@rush.edu

Principal Investigator

Ramandeep Kaur, PhD
PRINCIPAL_INVESTIGATOR
Rush University Medical Center
Babak Mokhlesi, MD
PRINCIPAL_INVESTIGATOR
Rush University Medical Center

Study Locations (Sites)

Rush University Medical Center
Chicago, Illinois, 60612
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Rush University Medical Center

  • Ramandeep Kaur, PhD, PRINCIPAL_INVESTIGATOR, Rush University Medical Center
  • Babak Mokhlesi, MD, PRINCIPAL_INVESTIGATOR, Rush University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-10
Study Completion Date2026-12-01

Study Record Updates

Study Start Date2023-07-10
Study Completion Date2026-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity, Morbid
  • Extubation Failure