Association of Near Infrared Spectroscopy With Interstage Outcomes
Part of paid clinical trials in Oak Lawn, Illinois.
- Sponsor
- Advocate Hospital System
- Study ID
- NCT06538571
- Status
- Recruiting
Conditions
- Single-ventricle
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - 6 Months
- Healthy Volunteers
- Not accepted
Interventions
- Near infrared spectroscopy — DIAGNOSTIC_TESTNoninvasive monitor for venous saturation
Study Details
The purpose of this study is to assess the utility of renal near infrared spectroscopy in the outpatient setting during the interstage period. The primary aim will be to determine the correlation between oxygen extraction ratio ((arterial pulse oximetry - renal near infrared spectroscopy value)/arterial pulse oximetry value) with need for inpatient admission or intervention. Secondary aims will be to determine the correlation of the oxygen extraction ratio with weight gain, neurodevelopment, unexpected admissions, systemic ventricular strain by echocardiography, and Glenn hospitalization admission characteristics.
Key Dates
- Start date
- Jul 1, 2024
- Status verified
- Aug 2024
- Primary completion
- Jul 1, 2025
- Completion
- Jul 1, 2026
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: NIRS usePatients will have renal near infrared spectroscopy recorded in clinic.
Primary Outcome Measure
Unexpected admissions [ Time Frame: 1 year ]
Central Contacts
- JOSHUA WONG, MD708-684-5580
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Advocate Childrens Hospital | Oak Lawn | Illinois | 60453 | Joshua Wong |
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