Association of Near Infrared Spectroscopy With Interstage Outcomes

Advocate Hospital System

Status: Enrolling

Conditions: Single-ventricle

Treatments: Diagnostic Test: Near infrared spectroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06538571

IRB00111841

Details and patient eligibility

About

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.

Full description

As above

Enrollment: 20 estimated patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants under 6 months of age
• Infants with single ventricle heart disease and parallel circulation
• Infants who are awaiting the Glenn operation
• Infants who are outpatient

Exclusion criteria

• Infants over 6 months of age
• Inpatients
• Infants with history of skin injury from the near infrared spectroscopy sensor inpatient
• Infants with ongoing hyperbilirubinemia

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

NIRS use

Experimental group

Description:

Patients will have renal near infrared spectroscopy recorded in clinic.

Treatment:

Diagnostic Test: Near infrared spectroscopy