PRecision Integrated Saturation Monitor
Part of paid clinical trials in Memphis, Tennessee.
- Sponsor
- Le Bonheur Children's Hospital
- Study ID
- NCT07686341
- Status
- Recruiting
Conditions
- CHD - Congenital Heart Disease
- Single Ventricle Heart Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 0 Months - 12 Months
- Healthy Volunteers
- Not accepted
Interventions
- vital sign monitoring — DEVICEThe 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.
Study Details
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.
Key Dates
- Start date
- Aug 31, 2026
- Status verified
- Jun 2026
- Primary completion
- Aug 31, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 100 participants (estimated)
Primary Outcome Measure
Abdominal SpO2 versus SaO2 [ Time Frame: From enrollment to end of study at 72 hours. ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Le Bonheur Children's Hospital | Memphis | Tennessee | 38105 |
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