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 @ 4:45 AM
Ignite Modification Date:
2025-12-25 @ 4:45 AM
NCT ID:
NCT03425318
Eligibility Criteria:
Inclusion Criteria:
1. Patients ≧ 18 years old
2. Patients with moderate to severe ARDS as per the Berlin definition (PaO2/FiO2 ≤200mmHg)
3. Patients with absence of any significant cardiopulmonary disease
Exclusion Criteria:
1. Contraindication to CNAP
a. open abdominal wounds or drainage tubes; b. Acute brain Injury with intracranial pressure \>30 mm Hg or cerebral perfusion pressure \<60 mmHg; c. Decompensated heart insufficiency or acute coronary syndrome; d. Major hemodynamic instability: Mean arterial pressure lower than 60 mm Hg despite adequate fluid resuscitation and two vasopressors or increase of vasopressor dose by 30% in the next 6 hours; f. Unstable spine, femur, or pelvic fractures; g. Pregnancy; h. Pneumothorax;
2. Contraindication to EIT electrode placement: Burns, chest wall bandaging limiting electrode placement
3. Severe liver insufficiency (Child-Pugh score \> 7) or fulminant hepatic failure
4. Major respiratory acidosis or PaCO2 \> 60 mmHg
5. Severe COPD (according to the GOLD criteria defined as severe = FEV1: 30-50% or very severe = FEV1 \< 30%)
6. Clinical judgement of the attending physician
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03425318
Study Brief:
Protocol Section:
NCT03425318