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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT05962905
Eligibility Criteria:
Inclusion Criteria:
1. Under 21 years of age
2. Meets weight requirement for sensors under study
3. Scheduled for a diagnostic or interventional cardiac catheterization procedure with general anesthesia or sedation
4. Arterial and venous access as part of the planned catheterization procedure
Exclusion Criteria:
1. Prior known severe allergies to medical grade adhesive/tape (Band-Aid) \[self-reported\]
2. A skin condition at the sensor site (e.g., rash, abrasion, laceration)
3. Craniofacial disease producing abnormal forehead anatomy and/or preventing forehead application of the sensor
4. A known structural brain lesion beneath the sensor
5. Known hemoglobinopathy
6. Inability to lie supine with neutral neck position during catheterization
7. Cerebrovascular disease
8. An emergent, life threatening condition impacting study conduct
9. Unwillingness or inability to sign informed consent (IC) or assent by the parents/guardians of child
10. Currently receiving phototherapy for bilirubin
11. Arterial or venous anatomy that would preclude obtaining an accurate paired sample
12. Known pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
21 Years
Study:
NCT05962905
Study Brief:
Protocol Section:
NCT05962905