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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT01717651
Eligibility Criteria:
A) Inclusion Criteria
1. Age ≥ 18 years
2. Required mechanical ventilation for at least 24 hours
B) Exclusion Criteria
1. Ventilator liberation anticipated in the next 24 hours
a. Rationale: short duration of illness anticipated, preventing achievement of primary endpoint
2. Known or suspected acute diagnosis of neuromuscular disease causing diffuse or lower extremity weakness (e.g. CVA, spinal cord injury or lesion, Muscular dystrophy, Myasthenia Gravis, GBS)
a. Rationale: chronic lower extremity weakness will impact anticipated physical recovery and relevance of atrophy observations
3. Pre-existing lower extremity weakness caused by prior injury, neuromuscular or joint disease
a. Rationale: Inability to participate in usual care therapy and CPM. Impacts functional recovery
4. Wounds, dressings or injuries of the lower extremities or pelvis that prevent muscle testing or CPM
a. Rationale: Inability to participate in US, exam or CPM
5. Patient's family, physician, or both not in favor of aggressive treatment of patient that includes life-sustaining treatments or the presence of an advance directive indicating the same a. Rationale: Unlikely to survive to seven day endpoint
6. More than seventy-two hours of continuous mechanical ventilation previously during this hospitalization
a. Rationale: Atrophy mechanisms already active and may degrade ability to detect early changes.
7. Non-English speaking subject or legally authorized representative
a. Rationale: This study does not have the funding necessary to translate consents and inability to ensure cooperation with testing.
8. Subject and/or Legally authorized representative unavailable to provide informed consent
9. Subject is a Prisoner
10. Pregnancy (excluded from CPM portion only) a. Rationale: Pregnant patients can develop the supine hypotensive syndrome (where the uterus compromises venous return due to compression of the IVC). This typically occurs only after 20 weeks gestation. To assure safety, any patient who self identifies as pregnant or has a positive urine pregnancy test on admission will not be offered CPM since it requires extended periods in the supine position.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01717651
Study Brief:
Protocol Section:
NCT01717651