Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05918575
• Other study ID #: 23050803
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2023
• Est. completion date: December 1, 2026

Study information

• Verified date: June 2024
• Source: Rush University Medical Center
• Contact: Ramandeep Kaur, PhD
• Phone: 3129478898
• Email: ramandeep_kaur[@]rush.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 for neurological reasons or for airway protection (stroke, intracerebral hemorrhage, intraventricular hemorrhage)

8. Intubated because of an acute exacerbation of COPD

9. Underlying neuromuscular disease

10. No reintubation requested by patient/family

11. Documented/known history of chronic hypercapnic respiratory failure on home NIV (including bilevel PAP).

12. Enrolled in any other outcome study

13. Treating clinician feels that HFNC or NIV are either mandatory or contraindicated for a given patient

Related Conditions & MeSH terms

• Extubation Failure
• Obesity, Morbid

Intervention

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.
• High flow nasal cannula
A total of 24 hours of prophylactic respiratory support will be provided using HFNC alone.

Locations

Country	Name	City	State
Mexico	Hospital Civil Fray Antonio Alcalde	Guadalajara	Jalisco
United States	Rush University Medical Center	Chicago	Illinois
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
Rush University Medical Center	Hospital Civil de Guadalajara, Medical College of Wisconsin

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment failure defined by use of rescue respiratory support for acute respiratory failure in the first 72 hours after planned extubation	Rescue respiratory support is defined as reintubation, use of rescue NIV or HFNC use	72 hours
Secondary	Reintubation rate	Need for invasive mechanical ventilation within 7 days of extubation	7 days