Postextubation Management in Patients at Risk for Extubation Failure

Not Applicable

Terminated

Brief Summary: 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: 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Experimental: alternating BiPAP and HFNC	BiPAP	Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation
Experimental: alternating BiPAP and HFNC	HFNC	Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation

Primary Outcome Measures

Name	Time	Method
Re-intubation Within 72 Hours	72 hours following extubation	The number of patients who require re-intubation

Secondary Outcome Measures

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