NCT05918575

Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity, Morbid
• Extubation Failure

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	High flow nasal cannula	A total of 24 hours of prophylactic respiratory support will be provided using HFNC alone.

Timeline

• Start date: 2023-07-10
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2023-06-26
• Last updated: 2025-10-20

Locations

5 sites across 2 countries: United States, Mexico

Regulatory

• FDA-regulated device study