RecruitingNot ApplicableNCT05918575

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

Sponsor

Rush University Medical Center

Enrollment

250 participants

Start Date

Jul 10, 2023

Study Type

INTERVENTIONAL

Conditions

Obesity, Morbid

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria12

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

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Interventions

DEVICENoninvasive 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.

DEVICEHigh flow nasal cannula

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