Clinical trial NCT04258020: Postextubation Management in Patients at Risk for Extubation Failure
Official title: Exploratory Trial to Improve Postextubation Management for Patients at Risk for Extubation Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ventilatory Failure
Lead sponsor: OhioHealth
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Re-intubation Within 72 Hours
timeFrame: 72 hours following extubation
Secondary outcomes:
measure: Re-intubation Within 1 Week
timeFrame: 1 week following extubation
measure: Length of Stay
timeFrame: Through hospital discharge, an average of 10.9 ± 1.91 days
measure: Ventilator Time
timeFrame: Through hospital discharge, an average of 10.9 ± 1.91 days
measure: Mortality
timeFrame: Through hospital discharge, an average of 10.9 ± 1.91 days
measure: Adverse Event Rate
timeFrame: Through 1 week following extubation
measure: 30-day Readmission
timeFrame: 30 days following discharge
Other outcomes:
Locations:
city: Columbus
country: United States
facility: OhioHealth Grant Medical Center
state: Ohio
Study officials:
affiliation: OhioHealth
name: Kiran Devulapally, MD
role: PRINCIPAL_INVESTIGATOR
References: