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:
NCT03803657
Eligibility Criteria:
Inclusion Criteria:
1. Mechanically ventilated neonates, infants and children, regardless of age, up to 10 kg
2. Inpatients in the cardiac (8S), medical-surgical (7S) or neonatal (7N) intensive care unit
3. Assent of patient's intensive care attending physician
4. Written parental informed consent.
5. Patient on conventional mechanical ventilation on a Servo I or Servo U ventilator with fraction of inspired oxygen \<80%.
Exclusion Criteria:
1. Clinically significant tracheo-esophageal fistula
2. Measured ETT leak \>20% (i.e. difference between inspiratory and expiratory tidal volumes)
3. Patient on high frequency oscillatory ventilation or high frequency jet ventilation.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03803657
Study Brief:
Protocol Section:
NCT03803657