Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05918575

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Civil Fray Antonio Alcalde, Guadalajara, Jalisco, Mexico

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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.

High Flow Nasal Cannula

Device

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

Primary outcomes

  1. Treatment failure defined by use of rescue respiratory support for acute respiratory failure in the first 72 hours after planned extubation

    Time frame: 72 hours

    Rescue respiratory support is defined as reintubation, use of rescue NIV or HFNC use

Secondary outcomes

  1. Reintubation rate

    Time frame: 7 days

    Need for invasive mechanical ventilation within 7 days of extubation

Study contacts

Contact information is provided by the study sponsor or research team.

Babak Mokhlesi, MD

CONTACT

[email protected]

(312) 563-0843

Ramandeep Kaur, PhD

CONTACT

[email protected]

3129478898

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2023
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.