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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT02963558
Eligibility Criteria:
Inclusion Criteria:
* Age ≥55 years old
* Admission to Wake Forest Baptist Medical Center Medical Intensive Care Unit
* Acute Hypoxic respiratory failure on mechanical ventilation for \<48 hours with a P:F ratio of \<300 (or equivalent S:F ratio)
* Previously Functional (over past 3 months, as reported by proxy):
Physical Function: Able to walk 4 m (with or without assistive device)
Exclusion Criteria:
* Neuromuscular Disease
* Cardiopulmonary Arrest with return of spontaneous circulation \<6 hrs
* Palliative Goals of Care; witholding life-sustaining therapy
* Elevated Intracranial Pressure (\>20 mm Hg)
* BMI\>45; absolute weight \>= 150 kg
* Inability to cycle (including absent limbs, body length \<1.5m, body habitus not fitting the cycle, inflammatory arthritis, significant joint problems including inability to bend arms/legs; pelvic and/or LE fracture, LE bypass surgery)
* Pregnancy
* Unable to speak English
* Use of continuous neuromuscular blockade
* Temporary Pacemaker or Swan Ganz catheter or femoral ECMO catheter/IABP
* Rhabdomyolysis with most recent CK \>5000
* Clinical diagnosis of dementia on medication
* Moribund
* Possible Exclusion: If the patient is on spine precautions, a discussion with the spine team will be necessary to determine eligibility for the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT02963558
Study Brief:
Protocol Section:
NCT02963558