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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT07173634
Eligibility Criteria:
Inclusion Criteria:
1. Adults (18-80 years) with tracheostomy
2. Prolonged DoC (\>28 days) confirmed by CRS-R score \>0
3. Ventilator-free \>48h
4. PaCO₂ \<60 mmHg
5. PCF ≥100 L/min
6. No sepsis/organ failure
7. Controlled pulmonary infection
8. Written informed consent by legal representative
Exclusion Criteria:
1. Intolerance to cuff deflation:
2. SpO₂ \<93% on O₂ supplementation OR Respiratory rate \>20/min for \>5min
3. Severe tracheal stenosis (\>50% lumen occlusion on CT)
4. Death within 2 weeks post-enrollment
5. Participation in conflicting interventional trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07173634
Study Brief:
Protocol Section:
NCT07173634