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:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-24 @ 7:56 PM
NCT ID:
NCT05506904
Eligibility Criteria:
Inclusion Criteria:
* With or without COVID-19
* In the intensive care unit (ICU)
* Able to provide informed consent (through a surrogate)
* Critically ill adults (ageā„18)
* Anticipated to need invasive ventilation for \>48 hours prior to an initial SBT
* Ready to undergo an initial SBT within the next 24 hours with a view to extubation as per treating MDs. As per the FAST trial, an SBT will be defined as a focused assessment on low ventilator settings \[T-piece, continuous positive airway pressure (CPAP), or PS \< 8 cm H2O regardless of positive end-expiratory pressure (PEEP)\]
Exclusion Criteria:
* Suffer from known or suspected peripheral severe myopathy or neuropathy, or limb weakness or paralysis or central (e.g., post arrest, large intracranial stroke or bleed) injury or Glasgow Coma Scale (GCS) \< 6
* Do not wish to be re-intubated as part of their treatment goals
* Were previously extubated during the same ICU admission
* Have undergone 1 or more SBTs
* Already have a tracheostomy
* Are moribund or expected to die.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05506904
Study Brief:
Protocol Section:
NCT05506904