Ventilatory Failure Clinical Trial
Official title:
Exploratory Trial to Improve Postextubation Management for Patients at Risk for Extubation Failure
Verified date | January 2022 |
Source | OhioHealth |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 6 |
Est. completion date | April 2, 2020 |
Est. primary completion date | February 25, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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) |
Country | Name | City | State |
---|---|---|---|
United States | OhioHealth Grant Medical Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
OhioHealth |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Re-intubation Within 72 Hours | The number of patients who require re-intubation | 72 hours following extubation | |
Secondary | Re-intubation Within 1 Week | The number of patients who require re-intubation | 1 week following extubation | |
Secondary | Length of Stay | Hospital length of stay | Through hospital discharge, an average of 10.9 ± 1.91 days | |
Secondary | Ventilator Time | The total duration of time patients spend on a ventilator | Through hospital discharge, an average of 10.9 ± 1.91 days | |
Secondary | Mortality | The proportion of patients who expire during the hospital stay | Through hospital discharge, an average of 10.9 ± 1.91 days | |
Secondary | Adverse Event Rate | The proportion of patients experiencing an adverse event | Through 1 week following extubation | |
Secondary | 30-day Readmission | The proportion of patients who require re-admission within 30 days of discharge | 30 days following discharge |
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