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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT06912360
Eligibility Criteria:
Inclusion Criteria:
All patients aged 18 years and older will be included in the study if they meet at least one of the following criteria :
* Acute respiratory distress, defined as dyspnea respiratory rate ≥ 25 cycles/min
* Hypoxemia, defined as the need for more 6 liters of oxygen to maintain an oxygen saturation (SpO2) of ≥ 92%. The fraction of inspired oxygen (FiO2) will be estimated using the 3% rule.
Exclusion Criteria:
Patients with any of the following criteria will not be included in the study:
* Pregnant or breastfeeding women
* Persons deprived of their liberty
* Exacerbation of asthma, chronic obstructive pulmonary disease, or another chronic respiratory disease
* Moderate to large amount of unilateral or bilateral undrained pleural effusion
* Contraindication to CPAP: patient refusal, undrained pneumothorax, chest injury, repeated or large vomiting, upper gastrointestinal bleeding, craniofacial trauma, severe upper airway obstruction, or tetraplegia in the initial phase
* Cardiac arrest, severe arrhythmias, shock requiring the use of vasopressors (norepinephrine, adrenaline, dopamine)
* Altered level of consciousness (Glasgow Coma Scale score \< 13), repeated seizures, or status epilepticus
* Medical decision to limit treatment: no intubation, no admission to intensive care
* Refusal to participate in the study or participation in another interventional study on respiratory distress or acute respiratory failure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06912360
Study Brief:
Protocol Section:
NCT06912360