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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT02399267
Eligibility Criteria:
Inclusion Criteria:
The investigators will include patients who are:
1. receiving invasive mechanical ventilation for \>= 24 hours.
2. capable of initiating spontaneous breaths on Pressure Support (PS) or Proportional Assist Ventilation (PAV) or triggering breaths on volume or pressure Assist Control (AC), volume or pressure Synchronized Intermittent Mandatory Ventilation (SIMV) ± PS, Pressure Regulated Volume Control (PRVC) or (Airway Pressure Release Ventilation) APRV,
3. with a fraction of inspired oxygen (FiO2) of =\< 70% and
4. with a positive end-expiratory pressure (PEEP) of =\< 12 cm H2O.
Exclusion Criteria:
The investigators will exclude patients who are
1. admitted after cardiopulmonary arrest or with brain death or expected brain death,
2. who have evidence of myocardial ischemia in the 24 hour period before enrollment,
3. who have received continuous invasive mechanical ventilation for \>= 2 weeks,
4. who have a tracheostomy in situ at the time of screening,
5. who are receiving sedative infusions for seizures or alcohol withdrawal,
6. who require escalating doses of sedative agents,
7. 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),
8. 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),
9. who have profound neurologic deficits (e.g. large intracranial stroke or bleed) or Glasgow Coma Scale (GCS) \< 6,
10. who are using modes that automate SBT conduct,
11. who are current enrolled in a confounding study that includes a weaning protocol, or
12. who were previously enrolled in this trial,
13. patients who have already undergone an SBT or who are on settings compatible with an SBT (T-piece, CPAP without PS (any level), or PS (=\< 8 cm H2O regardless of PEEP)
14. 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:
NCT02399267
Study Brief:
Protocol Section:
NCT02399267