Exploratory Trial to Improve Postextubation Management for Patients at Risk for Extubation Failure
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Ventilatory Failure
- Sponsor
- OhioHealth
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Re-intubation Within 72 Hours
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Re-intubation Within 72 Hours
Time Frame: 72 hours following extubation
The number of patients who require re-intubation
Secondary Outcomes
- Mortality(Through hospital discharge, an average of 10.9 ± 1.91 days)
- Re-intubation Within 1 Week(1 week following extubation)
- 30-day Readmission(30 days following discharge)
- Length of Stay(Through hospital discharge, an average of 10.9 ± 1.91 days)
- Ventilator Time(Through hospital discharge, an average of 10.9 ± 1.91 days)
- Adverse Event Rate(Through 1 week following extubation)