PRecision Integrated Saturation Monitor
NCT07686341 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2026-07-07
Summary
The purpose of this study is to find out if an abdominal pulse oximeter device is as accurate as a conventional fingertip pulse oximeter in pediatric patients. In this study, we will be collecting data from your medical record while you are being treated in the hospital for your clinical care. Your baby will be in the study for 3 days. There will be no additional study visits. We will collect information already being obtained while your baby is at the hospital.
Conditions
- CHD - Congenital Heart Disease
- Single Ventricle Heart Disease
Interventions
- DEVICE
-
vital sign monitoring
The intervention will be to evaluate abdominal SpO2 against both traditional fingertip readings and gold standard SaO2 measurements by collecting routine data from the medical chart that was performed as standard of care.
Sponsors & Collaborators
-
The Consortium for Technology & Innovation in Pediatrics (CTIP)
collaborator UNKNOWN -
Le Bonheur Children's Hospital
lead OTHER
Eligibility
- Min Age
- 0 Months
- Max Age
- 12 Months
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2028-08-31
- Completion
- 2028-12-31
Countries
- United States
Study Locations
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