Association of Near Infrared Spectroscopy With Interstage Outcomes
ConditionSingle-ventricle
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 6
SponsorAdvocate Hospital System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Single group
Treatments tested in this trial
Near infrared spectroscopy
Diagnostic testNoninvasive monitor for venous saturation
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: NIRS useExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Unexpected admissions
The investigators will investigate the correlation between renal near infrared spectroscopy values and unexpected admissions during the interstage period.
Time frame
1 year2
Unexpected interventions
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
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov