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 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT06854627
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Endotracheal intubation and mechanical ventilation for less than 72 hours
* Moderate-severe ARDS defined as:
1. Within 1 week of a known clinical insult or new or worsening respiratory symptoms
2. Bilateral infiltrates not fully explained by effusions, lobar/lung collapse, or nodules
3. Respiratory failure not fully explained by cardiac failure or fluid overload
4. PaO2/FiO2 \< 150 mmHg in supine position
* Prone positioning has been indicated by the attending physician, OR has already been initiated within the last 16 hours
Exclusion Criteria:
* Contraindications for prone positioning such as intracranial pressure \> 20 mmHg, massive hemoptysis, recent tracheal surgery or sternotomy or abdominal surgery with an open wound, recent facial trauma or facial surgery, unstable spine, femur, or pelvic fractures, or a single anterior chest tube with air leaks
* Patient on extracorporeal membrane oxygenation (ECMO) before randomization
* Chronic respiratory failure requiring oxygen therapy or non-invasive ventilation (NIV)
* Known pregnancy
* Anticipating withdrawal of life support or shift to palliative care
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06854627
Study Brief:
Protocol Section:
NCT06854627