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 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT05805293
Eligibility Criteria:
Inclusion Criteria:
1. Age \>18 years.
2. Obesity hypoventilation syndrome with acute hypercapnic respiratory failure. A) Body mass index \[BMI\] ≥ 30 kg/m2. B) Daytime hypercapnia (PaCO2 \> 45 mm Hg) C) PH \< 7.35 D) Arterial oxygen saturation (SaO2) \<90%
Exclusion Criteria:
1. Age \<18 years.
2. Pulmonary infiltrates suggesting pulmonary edema, pneumonia, active tuberculosis, or its sequelae.
3. Patients with gas exchange alterations due to other conditions, such as bronchiectasis, fibrosis of the pleural space (fibrothorax), neuromuscular disease and chronic obstructive pulmonary disease (COPD)
4. Pregnancy.
5. Contraindications for positive-airway pressure devices.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05805293
Study Brief:
Protocol Section:
NCT05805293