Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients

• Sponsor: Rush University Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05918575
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 41
• Patients Per Site Per Month: 6.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity, Morbid; Extubation Failure	Device: Noninvasive ventilation alternating with high flow nasal cannula; Device: High flow nasal cannula	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Randomized Controlled Trial of Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Jul 1, 2026
• Anticipated Study Completion Date: Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group (NIV with HFNC) Patients randomized to the intervention group will receive NIV alternating with HFNC for 24 hours after extubation	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.
Active Comparator: Control Group (HFNC alone) Patients randomized to the intervention group will receive HFNC only for 24 hours after extubation	Device: High flow nasal cannula; A total of 24 hours of prophylactic respiratory support will be provided using HFNC alone.

Outcome Measures

Primary Outcome Measures

1. 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

1. Reintubation rate [7 days]

   Need for invasive mechanical ventilation within 7 days of extubation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rush University Medical Center	Chicago	Illinois	United States	60612

Sponsors and Collaborators

• Rush University Medical Center

Investigators

• Principal Investigator: Ramandeep Kaur, Rush University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rush University Medical Center
• ClinicalTrials.gov Identifier: NCT05918575
• Other Study ID Numbers: 23050803
• First Posted: Jun 26, 2023
• Last Update Posted: Jun 27, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Obesity, Morbid

Study Results

No Results Posted as of Jun 27, 2023