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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Morbid; Extubation Failure
• Intervention / Treatment: Device: Noninvasive ventilation alternating with high flow nasal cannula; Device: High flow nasal cannula

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 Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ramandeep Kaur, PhD; Phone Number: 3129478898; Email: ramandeep_kaur@rush.edu
• Study Contact Backup: Name: Babak Mokhlesi, MD; Phone Number: (312) 563-0843; Email: babak_mokhlesi@rush.edu

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Recruiting
      • Hospital Civil Fray Antonio Alcalde
      • Contact: Miguel Ángel Ibarra Estrada; Email: drmiguelibarra@hotmail.com
      • Principal Investigator: Miguel Ángel Ibarra Estrada, MD
• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Contact: Ramandeep Kaur, PhD; Email: Ramandeep_Kaur@rush.edu
      • Contact: Babak Mokhlesi, MD; Email: babak_mokhlesi@rush.edu
      • Principal Investigator: Ramandeep Kaur, PhD
      • Principal Investigator: Babak Mokhlesi, MD
    • Winfield, Illinois, United States, 60190
      • Not yet recruiting
      • Central DuPage Hospital
      • Contact: Ankeet Patel; Email: Ankeet.Patel@nm.org
      • Principal Investigator: Ankeet Patel
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • McGovern Medical School, The University of Texas Health Science Center
      • Contact: Rosa M. Estrada-Y-Martin, MD; Email: rosa.m.estrada.y.martin@uth.tmc.edu
      • Principal Investigator: Rosa M. Estrada-Y-Martin, MD
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of Wisconsin
      • Contact: Rahul Nanchal, MD; Email: rnanchal@mcw.edu
      • Principal Investigator: Rahul Nanchal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reintubation rate	Need for invasive mechanical ventilation within 7 days of extubation	7 days

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: The University of Texas Health Science Center, Houston; Medical College of Wisconsin; Hospital Civil de Guadalajara; Central DuPage Hospital
• Investigators: Principal Investigator: Ramandeep Kaur, PhD, Rush University Medical Center; Principal Investigator: Babak Mokhlesi, MD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Estimated): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 16, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity, Morbid
• Other Study ID Numbers: 23050803

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes