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 @ 6:36 PM
Ignite Modification Date:
2025-12-24 @ 6:36 PM
NCT ID:
NCT00686257
Eligibility Criteria:
Inclusion Criteria:
* Age\>18
* Either A or B
A. Clinical Criteria: Moderate to severe respiratory distress as evidenced by tachypnea, use of accessory muscles for breathing, or abdominal paradox.
B. Blood Gas and Physiologic Criteria: Gas exchange abnormalities including PaCO2\>45 with a pH\<7.35, or a PaO2/FiO2 ratio\<200.
Exclusion Criteria:
* The need for immediate intubation
* Medical instability such as hypotensive shock, uncontrolled cardiac ischemia or arrythmias, unstable myocardial infarction, uncontrolled upper gastrointestinal bleeding
* Agitation or uncooperativeness, unresponsive to small doses of sedatives
* Excretions or inability to protect the airway
* Inability to fit the mask
* Facial trauma
* Upper airway obstruction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00686257
Study Brief:
Protocol Section:
NCT00686257