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 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 12:17 AM
NCT ID:
NCT04470258
Eligibility Criteria:
Inclusion Criteria:
* Adult patient, age\> or = 18 years, both sexes;
* Patient should be alert, oriented, and cooperative;
* When using oxygen therapy by CNO2\> or = 4L/min, MR\> or = 8 L/min of O2 or MV 50%, for maintain SpO2\> 92%;
* Gasometric parameters (pre ELMO, up to 30 min before): pH\> 7.35, PaO2\> 60 mmHg;
* RX or chest CT scan with bilateral parenchymal opacities from the last 24 hours.
Exclusion Criteria:
* Exacerbation of Asthma, Chronic Obstructive Pulmonary Disease (COPD), pulmonary fibrosis or other lung diseases;
* Hemodynamic instability (SBP \<90 mmHg or MBP \<65 mmHg or need for vasoactive drugs);
* Pneumothorax or pneumomediastinum;
* Respiratory acidosis (pH \<7.35 with PaCO2 \>46mmHg);
* Signs of respiratory muscle fatigue (paradoxical breathing, accessory muscle use);
* Nausea or vomiting;
* Disorders of the auditory canal;
* Use of nasoenteric or nasogastric feeding tubes;
* Imminent risk of respiratory arrest.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04470258
Study Brief:
Protocol Section:
NCT04470258