NCT06538571

Association of Near Infrared Spectroscopy With Interstage Outcomes

Association of Renal Near Infrared Spectroscopy in Outpatients With Parallel Circulation During the Interstage Period and Interstage Morbidity

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Advocate Hospital System · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

As above

Conditions

• Single-ventricle

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Near infrared spectroscopy	Noninvasive monitor for venous saturation

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-07-01
• Completion: 2026-07-01
• First posted: 2024-08-05
• Last updated: 2024-08-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study