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 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT02001220
Eligibility Criteria:
Inclusion Criteria:
* Receiving invasive mechanical ventilation for ≥ 24 hours.
* Capable of initiating spontaneous breaths on PS or triggering breaths on volume or pressure AC, volume or pressure SIMV ± PS, PRVC, or APRV.
* With an FiO2 ≤ 70%.
* With a PEEP ≤ 12 cm H₂O.
* \< 65 years of age
Exclusion Criteria:
* Patients admitted after cardiopulmonary arrest or with brain death or expected brain death.
* Patients who have evidence of myocardial ischemia in the 24 hour period before enrollment.
* Patients who have received continuous invasive mechanical ventilation for ≥ 2 weeks.
* Patients who have a tracheostomy in situ at the time of screening.
* Patients who are receiving sedative infusions for seizures or alcohol withdrawal.
* Patients who require escalating doses of sedative agents.
* Patients who are receiving neuromuscular blockers or who have known quadriplegia, paraplegia, or 4 limb weakness or paralysis preventing active mobilization (e.g. active range of motion, exercises in bed, sitting at edge of bed, transferring from bed to chair, standing, marching in place, ambulating).
* Patients who are moribund (e.g., at imminent risk for death) or who have limitations of treatment (e.g., withdrawal of support, do not reintubate order, however, do not resuscitate orders will be permitted).
* Patients who have profound neurologic deficits (e.g., large intracranial stroke or bleed) or Glasgow Coma Scale (GCS) ≤ 6.
* Patients who are using modes that automate SBT conduct.
* Patients who are currently enrolled in a confounding study that includes a weaning protocol.
* Patients who were previously enrolled in this trial.
* Patients who have already undergone an SBT.
* Patients who have already undergone extubation \[planned, unplanned (e.g. self, accidental)\] during the same ICU admission.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT02001220
Study Brief:
Protocol Section:
NCT02001220