Postextubation Management in Patients at Risk for Extubation Failure
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|ClinicalTrials.gov Identifier: NCT04258020|
Recruitment Status : Suspended (Study is on hold due to significant impact of COVID pandemic)
First Posted : February 6, 2020
Last Update Posted : October 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ventilatory Failure||Device: BiPAP Device: HFNC||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Exploratory Trial to Improve Postextubation Management for Patients at Risk for Extubation Failure|
|Actual Study Start Date :||February 11, 2020|
|Estimated Primary Completion Date :||June 1, 2022|
|Estimated Study Completion Date :||July 1, 2022|
Experimental: Experimental: alternating BiPAP and HFNC
Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation
Bilvel Positive Airway Pressure (BiPAP) oxygen administration
Heated High Flow Nasal Cannula oxygen administration
No Intervention: Historical Control: standard of care
A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation.
- Re-intubation rate within 72 hours [ Time Frame: 72 hours following extubation ]The proportion of patients who require re-intubation
- Re-intubation rate within 1 week [ Time Frame: 1 week following extubation ]The proportion of patients who require re-intubation
- Length of stay [ Time Frame: Through hospital discharge, an average of 14.1 ± 16.9 days ]Hospital length of stay
- Ventilator time [ Time Frame: Through hospital discharge, an average of 14.1 ± 16.9 days ]The total duration of time patients spend on a ventilator
- Mortality [ Time Frame: Through hospital discharge, an average of 14.1 ± 16.9 days ]The proportion of patients who expire during the hospital stay
- Adverse event rate [ Time Frame: Through 1 week following extubation ]The proportion of patients experiencing an adverse event
- 30-day readmission [ Time Frame: 30 days following discharge ]The proportion of patients who require re-admission within 30 days of discharge
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04258020
|United States, Ohio|
|OhioHealth Grant Medical Center|
|Columbus, Ohio, United States, 43215|
|Principal Investigator:||Kiran Devulapally, MD||OhioHealth|