Postextubation Management in Patients at Risk for Extubation Failure

Study Overview
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Brief Summary
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At the time of weaning from mechanical ventilation, patients with heart and/or lung conditions will be given oxygen support with alternating bilevel positive airway pressure (BiPAP; oxygen via face mask) and heated high flow nasal cannula oxygen (HFNC; oxygen via nasal cannula) to see if this method reduces the likelihood of re-intubation.

Detailed Description
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It is clinically challenging to predict when patients can be successfully removed from mechanical ventilation (MV). Liberating high-risk patients such as the elderly and those with complex, chronic cardiac or pulmonary diseases from MV is particularly challenging. Evidence from randomized trials and meta-analyses suggests that the type of postextubation supportive care provided, such as oxygen delivery via nose or mouth, may affect the risk of reintubation. However, it is unclear which of many possible postextubation management protocols results in the best patient outcomes, particularly for this subset of high-risk patients. The purpose of this study is therefore to assess a standardized combined protocol of postextubation oxygen delivery consisting of early, alternating BiPAP with HFNC over 24 hours following extubation. BiPAP and HFNC are both currently provided to patients as standard of care, based on clinician judgement; however, the timing and nature of the methods are variable.

Official Title
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Exploratory Trial to Improve Postextubation Management for Patients at Risk for Extubation Failure

Conditions
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Ventilatory Failure

Intervention / Treatment
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* Device: BiPAP
* Device: HFNC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented high-risk factors of interest [congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), and/or positive fluid balance] The modified rapid shallow breathing index on day of extubation must be between 58-105 breaths per minute per liter (breaths/min/L) Patient must successfully complete spontaneous breathing trial and be determined eligible for extubation Only primary extubations will be included Exclusion Criteria: Undergoing terminal extubation or placed on comfort care Home ventilator use Any contraindication that would preclude the postextubation protocol (e.g., facial trauma, tracheotomy, or any other reason that would preclude use of BiPAP or HFNC)

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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: alternating BiPAP and HFNC<br>Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation | Device: BiPAP<br>* Bilevel Positive Airway Pressure (BiPAP) oxygen administration<br>Device: HFNC<br>* Heated High Flow Nasal Cannula oxygen administration<br>|
| No Intervention: Historical Control: standard of care<br>A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-intubation Within 72 Hours | The number of patients who require re-intubation | 72 hours following extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-intubation Within 1 Week | The number of patients who require re-intubation | 1 week following extubation | 
| Length of Stay | Hospital length of stay | Through hospital discharge, an average of 10.9 ± 1.91 days | 
| Ventilator Time | The total duration of time patients spend on a ventilator | Through hospital discharge, an average of 10.9 ± 1.91 days | 
| Mortality | The proportion of patients who expire during the hospital stay | Through hospital discharge, an average of 10.9 ± 1.91 days | 
| Adverse Event Rate | The proportion of patients experiencing an adverse event | Through 1 week following extubation | 
| 30-day Readmission | The proportion of patients who require re-admission within 30 days of discharge | 30 days following discharge |