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Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients

NCT05918575 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-10-20

No results posted yet for this study

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

Interventions

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.

DEVICE

High flow nasal cannula

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

Sponsors & Collaborators

  • Hospital Civil de Guadalajara

    collaborator OTHER

  • Medical College of Wisconsin

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • Central DuPage Hospital

    collaborator OTHER

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Ramandeep Kaur, PhD · Rush University Medical Center

  • Babak Mokhlesi, MD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-10
Primary Completion
2026-07-01
Completion
2026-12-01
FDA Device
Yes

Countries

  • United States
  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05918575 on ClinicalTrials.gov