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 @ 1:38 PM
Ignite Modification Date:
2025-12-24 @ 1:38 PM
NCT ID:
NCT03139695
Eligibility Criteria:
Inclusion Criteria
* Patients will be included if first ultrasound measurement can be performed within 48 hours of ICU admission and informed consent can be obtained from patient or designated health care representative.
* Adult patients (≥ 18 years of age) in any intensive care unit.
* Patients who are expected to have the need for prolonged mechanical ventilation (treating physician's assessments that patient will likely need mechanical ventilation for \>48 hours; 2 days) and have been on mechanical ventilation for \<48 hours at the time of enrollment.
Exclusion Criteria
* Patients in any ICU who is expected to be on mechanical ventilation for \<48 hours based on treating physicians judgment.
* Patients that were on MV for more than 48 hours prior to transfer to the ICU.
* Patients who are expected to be extubated, transferred out of the ICU or discharged from the intensive care unit in the next 48 hours based on treating physicians judgment.
* Patients who are transitioning to palliative care or expected to die in the next 48 hours based on treating physicians judgment.
* Any patient where access to chest to study intercostal muscle and diaphragm is limited due to skin /subcutaneous lesions.
* Patients with a history of or current chest tubes, chest trauma or anterior rib fractures.
* Patients with a history of prior MV \>48 hours or prior history of tracheostomy.
* Patients with a history of chest or abdominal surgery.
* Patients that have a tracheotomy or require non-standard modes of ventilation including airway pressure release ventilation or high frequency oscillatory ventilation.
* Patients with physician orders for positioning of the patient is different from head of the bed at 30 degree. E.g. patients with recent lumbar spinal surgery are laid flat to reduce spinal fluid pressure in lumbar area.
* Patients with a known allergy to ultrasound gel
* Pregnant women
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03139695
Study Brief:
Protocol Section:
NCT03139695