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 @ 11:47 AM
Ignite Modification Date:
2025-12-24 @ 11:47 AM
NCT ID:
NCT01751061
Eligibility Criteria:
Inclusion Criteria (Patient characteristics required for surrogate inclusion)
* age ≥18
* ≥10 days of mechanical ventilation interrupted by \<96 continuous hours of unassisted breathing (including invasive and non-invasive ventilation)
* no anticipation of imminent (24 hours) death or extubation by the attending.
Exclusion Criteria (Patient characteristics that will exclude surrogates from study enrollment):
* possession of decisional capacity
* no identifiable surrogate, surrogate is unavailable for study procedures such as interviews
* imminent organ transplantation
* chronic neuromuscular disease
* physician refuses permission to approach family and/or patient for consent
* admission for severe burns
* admission for high cervical spine injury
* ventilation for \>21 days.
Inclusion criteria for surrogate decision makers:
* age ≥18
* self-identified as participating directly in health care decision making for the incapable patient under relevant state law
Exclusion criteria for surrogate decision makers:
* do not personally know the patient
* need translation assistance because of poor English fluency (the decision aid has not been validated in other languages)
* history of clinically important neurological disorder (e.g., dementia)
* patient dies after meeting inclusion criteria but before surrogates provide consent
Physician and nurse inclusion criteria:
* ICU attending or fellow (physicians) at the time of surrogate enrollment
* bedside ICU nurse present at the time of surrogate enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01751061
Study Brief:
Protocol Section:
NCT01751061