Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT04258020
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04258020
Study Brief:
Protocol Section:
NCT04258020