Near Infrared Spectroscopy (NIRS) for Heart Failure Assessment.

Study Overview
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Brief Summary
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It is routine practice for a cardiologist to perform a battery of tests to assess the degree of heart failure. The purpose of this study is to establish a non-invasive method to reliably predict cardiac output state in real-time in children and adolescents with heart failure in an outpatient setting. This study will rely on the use of near infrared spectroscopy monitors to measure cardiac output in the outpatient setting.

Detailed Description
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Near-infrared spectroscopy (NIRS) technology, such as that used in pulse oximetry, has been used in medicine for decades. Several characteristics contribute to its widespread use, including its noninvasive nature, reliability and safety. The Somanetics' INVOS® System harnesses this power to safely and reliably see inside the brain and body. NIRS devices measure the venous weighted oxy-hemoglobin saturation (color of blue blood) in a field of tissue, rather than in arteries, and thus the rSO2 parameter provides a window into regional oxygen supply-demand relationships. Monitoring rSO2 at two distinct sites (cerebral and somatic) has become common practice at our institution for all infants and children in the intensive care unit and provides valuable feedback about potentially deleterious trends in regional tissue oxygenation that cannot easily be obtained by other modalities in such patients.

Official Title
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Near Infrared Spectroscopy (NIRS) for Heart Failure Assessment in the Outpatient Setting

Conditions
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Cardiac Failure

Intervention / Treatment
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* Device: Near Infrared Spectroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient in Phoenix Children's Hospital Heart Failure Clinic Exclusion Criteria: N/A

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Near Infrared Spectroscopy|Use of Near Infrared Spectroscopy in outpatient setting to determine global cardiac output|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of Heart Failure using NIRS | The investigators strive to discover a surrogate marker for uncompensated heart failure. The use of two-site NIRS monitoring for global cardiac output assessment, through the patterning of somatic and cerebral saturation data in combination with pulse-oximetry data and other vital signs in the outpatient setting, has not been researched although it is used widely in the inpatient arena. | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NIRS, near infrared spectroscopy, heart failure, cardiac output, outpatient, pediatric