Single-ventricle
Conditions
Brief 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
Interventions
DIAGNOSTIC_TESTNear infrared spectroscopy
Noninvasive monitor for venous saturation
Sponsors
Advocate Hospital System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unexpected admissions | 1 year | The investigators will investigate the correlation between renal near infrared spectroscopy values and unexpected admissions during the interstage period. |
| Unexpected interventions | 1 year | The investigators will investigate the correlation between renal near infrared spectroscopy values and unexpected need for interventions such as cardiac catheterization interventions or surgical interventions |
Countries
United States
Contacts
Primary ContactJOSHUA WONG, MD
Outcome results
None listed