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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT03865056
Eligibility Criteria:
Inclusion Criteria:
1. Hypoxemia defined by a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2:FiO2) ≤ 300 while the patient is breathing oxygen through NHF for at least 15 minutes;
2. Respiratory rate \> 25 breaths/minute;
3. Partial pressure of arterial carbon dioxide (PaCO2) ≤ 45 mmHg;
4. Absence of clinical history of underlying chronic respiratory failure.
Exclusion Criteria:
1. Lack of consent;
2. Age \< 18 years;
3. Invasive mechanical ventilation for \> 48 hours in the same hospital admission
4. Immediate need for intubation;
5. Previous inclusion in the present study;
6. Systolic arterial pressure \< 90 mmHg after optimal fluid therapy;
7. Cardiogenic pulmonary edema;
8. Glasgow Coma Scale \< 12;
9. Imminent death;
10. Contraindications to noninvasive ventilation;
11. Tracheostomy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03865056
Study Brief:
Protocol Section:
NCT03865056