Clinical trial NCT01577810: Near Infrared Spectroscopy (NIRS) for Heart Failure Assessment.
Official title: Near Infrared Spectroscopy (NIRS) for Heart Failure Assessment in the Outpatient Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Failure
Keywords: NIRS
near infrared spectroscopy
heart failure
cardiac output
outpatient
pediatric
Lead sponsor: Phoenix Children's Hospital
Sponsor class: OTHER
First posted: 2012-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Patient in Phoenix Children's Hospital Heart Failure Clinic

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Degree of Heart Failure using NIRS
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital Heart Failure Clinic
state: Arizona
Study officials:
affiliation: Phoenix Children's Hospital
name: Rohit Rao, MD
role: PRINCIPAL_INVESTIGATOR
References:
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