Near Infrared Spectroscopy (NIRS) for Heart Failure Assessment.

Overview

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.

Full Title of Study: “Near Infrared Spectroscopy (NIRS) for Heart Failure Assessment in the Outpatient Setting”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Diagnostic
  • Masking: None (Open Label)
• Study Primary Completion Date: June 2014

Detailed Description

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.

Interventions

• Device: Near Infrared Spectroscopy
  • Use of Near Infrared Spectroscopy in outpatient setting to determine global cardiac output

Clinical Trial Outcome Measures

Primary Measures

• Degree of Heart Failure using NIRS
  • Time Frame: 5 minutes
  • 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.

Participating in This Clinical Trial

Inclusion Criteria

• Patient in Phoenix Children's Hospital Heart Failure Clinic Exclusion Criteria:

• N/A

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Phoenix Children’s Hospital
• Provider of Information About this Clinical Study
  • Principal Investigator: Rohit Rao, M.D., Cardiac Intensivist – Phoenix Children’s Hospital
• Overall Official(s)
  • Rohit Rao, MD, Principal Investigator, Phoenix Children’s Hospital
• Overall Contact(s)
  • Rohit Rao, MD, (262)309-4874, rrao@phoenixchildrens.com

References

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