Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients
Recruiting · NCT05918575 · Interventional (participants receive a specific treatment) · Lead sponsor: Rush University Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
High flow nasal cannulaNoninvasive ventilation alternating with high flow nasal cannula
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
5 locations listed across 3 US states.
- Rush University Medical Center - Chicago, Illinois, United States
- Central DuPage Hospital - Winfield, Illinois, United States
- McGovern Medical School, The University of Texas Health Science Center - Houston, Texas, United States
- Medical College of Wisconsin - Milwaukee, Wisconsin, United States
- Hospital Civil Fray Antonio Alcalde - Guadalajara, Jalisco, Mexico