Trial record 2 of 3 for:    14752434 [PUBMED-IDS]

Near Infrared Spectroscopy (NIRS) for Heart Failure Assessment.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01577810
Recruitment Status : Unknown
Verified June 2013 by Rohit Rao, M.D., Phoenix Children's Hospital.
Recruitment status was:  Recruiting
First Posted : April 16, 2012
Last Update Posted : June 7, 2013
Information provided by (Responsible Party):
Rohit Rao, M.D., Phoenix Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Cardiac Failure Device: Near Infrared Spectroscopy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Near Infrared Spectroscopy (NIRS) for Heart Failure Assessment in the Outpatient Setting
Study Start Date : June 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Intervention Details:
  • Device: Near Infrared Spectroscopy
    Use of Near Infrared Spectroscopy in outpatient setting to determine global cardiac output
    Other Names:
    • NIRs
    • INVOS

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient in Phoenix Children's Hospital Heart Failure Clinic

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01577810

Contact: Rohit Rao, MD (262)309-4874
Contact: Jennifer Matchey, MD (602)9093578

United States, Arizona
Phoenix Children's Hospital Heart Failure Clinic Recruiting
Phoenix, Arizona, United States, 85016
Contact: Rohit Rao, MD    262-309-4874   
Contact: Jennifer Matchey, MD    (602)909-3578   
Principal Investigator: Rohit Rao, MD         
Sub-Investigator: Jennifer Matchey, MD         
Sponsors and Collaborators
Phoenix Children's Hospital
Principal Investigator: Rohit Rao, MD Phoenix Children's Hospital


Responsible Party: Rohit Rao, M.D., Cardiac Intensivist, Phoenix Children's Hospital Identifier: NCT01577810     History of Changes
Other Study ID Numbers: PHNX-NIRS-12-024
First Posted: April 16, 2012    Key Record Dates
Last Update Posted: June 7, 2013
Last Verified: June 2013

Keywords provided by Rohit Rao, M.D., Phoenix Children's Hospital:
near infrared spectroscopy
heart failure
cardiac output

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases