Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Noninvasive ventilation alternating with high flow nasal cannula, High flow nasal cannula.
- Who it may be relevant to
- Registry conditions: Obesity, Morbid, Extubation Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Trial of Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients
Overview
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.
Detailed description
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.
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.
Primary outcome measures
- 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]
Secondary outcome measures (1)
- Reintubation rate [Time frame: 7 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 4 centers
- Rush University Medical Center — Chicago
- Central DuPage Hospital — Winfield
- McGovern Medical School, The University of Texas Health Science Center — Houston
- Medical College of Wisconsin — Milwaukee
Mexico · 1 center
- Hospital Civil Fray Antonio Alcalde — Guadalajara
Identifiers
NCT: NCT05918575 · 23050803