Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients

NCT05918575 | Recruiting FDA Device

• 1 other identifier: 23050803
• Study Type: interventional
• Target: 250
• Locations: 2 countries
• Sites: 5

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.

Conditions

Obesity, Morbid; Extubation Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reintubation rate

  7 days

Study Arms (2)

Intervention Group (NIV with HFNC)

EXPERIMENTAL

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

Control Group (HFNC alone)

ACTIVE COMPARATOR

Patients randomized to the intervention group will receive HFNC only for 24 hours after extubation

Device: High flow nasal cannula

Interventions

Noninvasive ventilation alternating with high flow nasal cannula DEVICE

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.

Intervention Group (NIV with HFNC)

High flow nasal cannula DEVICE

A total of 24 hours of prophylactic respiratory support will be provided using HFNC alone.

Control Group (HFNC alone)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult, age ≥ 18 years old
• Receiving invasive mechanical ventilation for ≥24 hours
• BMI ≥40 kg/m2
• Undergoing planned extubation per treating team
• Arterial pH ≥7.35 or venous pH ≥ 7.31 within 30 mins of spontaneous breathing trial (SBT)

You may not qualify if:

• Pregnant
• Use of extra-corporeal membrane oxygenation
• Chronic tracheostomy in place
• Unplanned or accidental extubation
• Terminal/compassionate extubation
• Contraindication to NIV use
• Intubated because of an acute exacerbation of COPD
• Underlying neuromuscular disease
• No reintubation requested by patient/family
• Documented/known history of chronic hypercapnic respiratory failure on home NIV (including bilevel PAP).
• Enrolled in any other outcome study
• Treating clinician feels that HFNC or NIV are either mandatory or contraindicated for a given patient

Sponsors & Collaborators

• Rush University Medical Center: lead
• Hospital Civil de Guadalajara: collaborator
• Medical College of Wisconsin: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• Central DuPage Hospital: collaborator

Study Sites (5)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Central DuPage Hospital

Winfield, Illinois, 60190, United States

NOT YET RECRUITING

McGovern Medical School, The University of Texas Health Science Center

Houston, Texas, 77030, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Hospital Civil Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ramandeep Kaur, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Babak Mokhlesi, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramandeep Kaur, PhD

CONTACT

3129478898; ramandeep_kaur@rush.edu

Babak Mokhlesi, MD

CONTACT

(312) 563-0843; babak_mokhlesi@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 26, 2023
• Study Start: July 10, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1); US (4)