Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients

Not Applicable

Recruiting

• Conditions: Extubation Failure; Obesity, Morbid
• Interventions: Device: High flow nasal cannula; Device: Noninvasive ventilation alternating with high flow nasal cannula

• Registration Number: NCT05918575
• Lead Sponsor: Rush University Medical Center

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.

Detailed Description

Patients with obesity are at risk of developing respiratory failure due to reduced lung volumes and chest wall compliance. Obesity is one of the easily identifiable, contributing factors of extubation failure that often leads to prolonged mechanical ventilation use and ICU stay. The early application of noninvasive respiratory support, especially NIV, has been shown to reduce reintubation rates in obese patients in a small, non-randomized study. However, prolonged use of NIV is often associated with decreased patient compliance and increased incidence of skin breakdown. HFNC is a noninvasive strategy that is comfortable, uses a nasal cannula and provides a high flow rate to meet the patient's inspiratory flow demand and thereby reduce work of breathing.

The purpose of this RCT will be to determine the effects of using NIV alternating with HFNC for reducing the treatment failure rate compared with HFNC alone in extubated patients with severe obesity. We hypothesize that early, prophylactic use of NIV alternating with HFNC will decrease the risk of respiratory failure (treatment failure) in severely obese patients.

Study Timeline

• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-06-15
• Study First Posted: 2023-06-26
• Study Start: 2023-07-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-07-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group (HFNC alone)	High flow nasal cannula	Patients randomized to the intervention group will receive HFNC only for 24 hours after extubation
Intervention Group (NIV with HFNC)	Noninvasive ventilation alternating with high flow nasal cannula	Patients randomized to the intervention group will receive NIV alternating with HFNC for 24 hours after extubation

Primary Outcome Measures

Name	Time	Method
Treatment failure defined by use of rescue respiratory support for acute respiratory failure in the first 72 hours after planned extubation	72 hours	Rescue respiratory support is defined as reintubation, use of rescue NIV or HFNC use

Secondary Outcome Measures

Name	Time	Method
Reintubation rate	7 days	Need for invasive mechanical ventilation within 7 days of extubation

Trial Locations

Locations (4)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

McGovern Medical School, The University of Texas Health Science Center; 🇺🇸 Houston, Texas, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Hospital Civil Fray Antonio Alcalde; 🇲🇽 Guadalajara, Jalisco, Mexico