A Randomized Controlled Trial of Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
United States
Illinois
Rush University Medical Center
RECRUITING
Chicago
Central DuPage Hospital
NOT_YET_RECRUITING
Winfield
Texas
McGovern Medical School, The University of Texas Health Science Center
RECRUITING
Houston
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Mexico
Hospital Civil Fray Antonio Alcalde
RECRUITING
Guadalajara
Contact Information
Primary
Ramandeep Kaur, PhD
ramandeep_kaur@rush.edu
3129478898
Backup
Babak Mokhlesi, MD
babak_mokhlesi@rush.edu
(312) 563-0843
Time Frame
Start Date: 2023-07-10
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 250
Treatments
Experimental: Intervention Group (NIV with HFNC)
Patients randomized to the intervention group will receive NIV alternating with HFNC for 24 hours after extubation
Active_comparator: Control Group (HFNC alone)
Patients randomized to the intervention group will receive HFNC only for 24 hours after extubation
Sponsors
Collaborators: The University of Texas Health Science Center, Houston, Medical College of Wisconsin, Hospital Civil de Guadalajara, Central DuPage Hospital
Leads: Rush University Medical Center