Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Morbid, Extubation Failure

Intervention / Treatment
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* Device: Noninvasive ventilation alternating with high flow nasal cannula
* Device: High flow nasal cannula


Participation Criteria
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Eligibility Criteria
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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 for neurological reasons or for airway protection (stroke, intracerebral hemorrhage, intraventricular hemorrhage) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group (NIV with HFNC)<br>Patients randomized to the intervention group will receive NIV alternating with HFNC for 24 hours after extubation | Device: Noninvasive ventilation alternating with high flow nasal cannula<br>* 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.<br>|
| Active Comparator: Control Group (HFNC alone)<br>Patients randomized to the intervention group will receive HFNC only for 24 hours after extubation | Device: High flow nasal cannula<br>* A total of 24 hours of prophylactic respiratory support will be provided using HFNC alone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure defined by use of rescue respiratory support for acute respiratory failure in the first 72 hours after planned extubation | Rescue respiratory support is defined as reintubation, use of rescue NIV or HFNC use | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reintubation rate | Need for invasive mechanical ventilation within 7 days of extubation | 7 days |