Recruiting

Noninvasive Respiratory Support

Sponsor:

Rush University Medical Center

Code:

NCT05918575

Conditions

Obesity, Morbid

Extubation Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Noninvasive ventilation alternating with high flow nasal cannula

High flow nasal cannula

Study Details

Brief 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.

Conditions

Obesity, Morbid

Extubation Failure

Study ID

NCT05918575

Start date

Jul 10, 2023

Status verified date

Aug, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

Interventions

Noninvasive ventilation alternating with high flow nasal cannula

A total of 24 hours of prophylactic respiratory support will be provided using NIV alternating with HFNC with total NIV usage of 16 hours and HFNC usage of 8 hours.

High flow nasal cannula

A total of 24 hours of prophylactic respiratory support will be provided using HFNC alone.

Primary outcome measure

  • Treatment failure defined by use of rescue respiratory support for acute respiratory failure in the first 72 hours after planned extubation [ Time Frame: 72 hours ]

Central Contacts and Locations

Central contacts

Ramandeep Kaur, PhD

3129478898ramandeep_kaur@rush.edu

Babak Mokhlesi, MD

(312) 563-0843babak_mokhlesi@rush.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Ramandeep Kaur, PhD

ramandeep_kaur@rush.edu

Babak Mokhlesi, MD

babak_mokhlesi@rush.edu

Principal Investigator:

Ramandeep Kaur, PhD

McGovern Medical School, The University of Texas Health Science Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Rosa M. Estrada-Y-Martin, MD

rosa.m.estrada.y.martin@uth.tmc.edu

Principal Investigator:

Rosa M. Estrada-Y-Martin, MD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Rahul Nanchal, MD

rnanchal@mcw.edu

Principal Investigator:

Rahul Nanchal, MD

More Information

Sponsor

Rush University Medical Center

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-08-07.