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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT04619667
Eligibility Criteria:
Inclusion Criteria:
* presence of hypoxemic Acute Respiratory Failure, as defined by a respiratory rate greater than 25 breaths/min, an acute onset (within 1 week) of respiratory distress, an arterial oxygen tension (PaO2) and inspiratory oxygen fraction (FiO2) ratio (PaO2/FiO2) lower than 200 mmHg during HFNC, an evidence of bilateral pulmonary infiltrates in the chest X-ray or computed tomography scan, and an absence of history of chronic respiratory failure or moderate-to-severe cardiac insufficiency (New York Heart Association greater than grade 2 or left ventricular ejection fraction \<50%).
Exclusion Criteria:
* reduced level of consciousness, as indicated by a Glasgow Coma Scale \< 12
* severe respiratory distress (i.e. respiratory rate \> 35 breaths/min)
* hemodynamic instability, (i.e. systolic arterial pressure \<90 mmHg or mean systolic pressure \<65 mmHg despite fluid repletion)
* need for vasoactive agents, i.e. vasopressin or epinephrine at any dosage, or norepinephrine \>0.3 mcg/kg/min or dobutamine\>5 mcg/kg/min
* life-threatening arrhythmias or electrocardiographic signs of ischemia
* acute respiratory failure secondary to neurological disorders, status asthmaticus, chronic obstructive pulmonary disease (COPD), cardiogenic pulmonary oedema
* presence of tracheotomy
* uncontrolled vomiting
* more than 2 acute organ failures
* body mass index \>30 kg/m2
* documented history or suspicion of obstructive sleep apnoea
* contraindications to placement of a nasal-gastric feeding tube
* facial anatomy contraindicating helmet or nasal cannula application
* inclusion in other research protocols.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04619667
Study Brief:
Protocol Section:
NCT04619667