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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT03534960
Eligibility Criteria:
Inclusion Criteria:
1. Age ranges from 1 to 18 years
2. Hypercapnic respiratory failure:
PaO2\<60mmHg and PaCO2 \>50 mmHg
3. Candidate for non-invasive respiratory support as a result of:
1. an intention to manage the patient with non-invasive (no endotracheal tube) respiratory support
2. an intention to extubate the patient being managed with intubated respiratory support to non-invasive support
Exclusion Criteria:
1. Participation in a concurrent study that prohibits the use of HHFNC
2. Active air leak syndrome
3. Patients with abnormalities of the upper and lower airways; such as Pierre- Robin, Treacher-Collins, Goldenhar, choanal atresia or stenosis,
4. Patients with significant abdominal or respiratory malformations including tracheo-esophageal fistula, intestinal atresia, omphalocele, gastroschisis, and congenital diaphragmatic hernia
5. PaCO2\<50mmHg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
18 Years
Study:
NCT03534960
Study Brief:
Protocol Section:
NCT03534960