Near Infrared Spectroscopy (NIRS) for Heart Failure Assessment.
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Near Infrared Spectroscopy (NIRS) for Heart Failure Assessment in the Outpatient Setting|
- Degree of Heart Failure using NIRS [ Time Frame: 5 minutes ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Device: Near Infrared Spectroscopy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577810
|Contact: Rohit Rao, MD||(262)firstname.lastname@example.org|
|Contact: Jennifer Matchey, MD||(602)email@example.com|
|United States, Arizona|
|Phoenix Children's Hospital Heart Failure Clinic||Recruiting|
|Phoenix, Arizona, United States, 85016|
|Contact: Rohit Rao, MD 262-309-4874 firstname.lastname@example.org|
|Contact: Jennifer Matchey, MD (602)909-3578 email@example.com|
|Principal Investigator: Rohit Rao, MD|
|Sub-Investigator: Jennifer Matchey, MD|
|Principal Investigator:||Rohit Rao, MD||Phoenix Children's Hospital|