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 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT01242150
Eligibility Criteria:
Inclusion Criteria:
* PaO2/FiO2 ratio \<300
* Respiratory rate \>50 breaths/min
* Chest x-ray compatible with pulmonary infection
* No clinical improvement after breathing oxygen at 8 l/min or more for at least 15 min
Exclusion Criteria:
* Presence of an endotracheal tube or a tracheostomy before PICU admission
* Facial deformities
* Upper airway obstruction
* Cyanotic congenital heart disease
* Facial trauma
* Recurrent apnea
* Neuromuscular weakness
* Pulmonary hypoplasia
* Pulmonary vascular anomalies
* Imminent respiratory or cardiac arrest
* COPD and/or chronic CO2 retention
* Status asthmaticus
* Pneumothorax
* Hemodynamic instability
* Alteration in consciousness with a Glasgow coma score (GCS) \<10
* Aspiration or excessive bronchial secretions
* Enrollment in other research protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
24 Months
Study:
NCT01242150
Study Brief:
Protocol Section:
NCT01242150