Near Infrared Spectroscopy (NIRS) for Heart Failure Assessment.

This study is currently recruiting participants.
Verified June 2013 by Phoenix Children's Hospital
Sponsor:
Information provided by (Responsible Party):
Rohit Rao, M.D., Phoenix Children's Hospital
ClinicalTrials.gov Identifier:
NCT01577810
First received: March 23, 2012
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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 Intervention
Cardiac Failure
Device: Near Infrared Spectroscopy

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Phoenix Children's Hospital:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
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)
Intervention Details:
    Device: Near Infrared Spectroscopy
    Use of Near Infrared Spectroscopy in outpatient setting to determine global cardiac output
    Other Names:
    • NIRs
    • INVOS
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

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient in Phoenix Children's Hospital Heart Failure Clinic

Exclusion Criteria:

  • N/A
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577810

Contacts
Contact: Rohit Rao, MD (262)309-4874 rrao@phoenixchildrens.com
Contact: Jennifer Matchey, MD (602)9093578 jmatchey@phoenixchildrens.com

Locations
United States, Arizona
Phoenix Children's Hospital Heart Failure Clinic Recruiting
Phoenix, Arizona, United States, 85016
Contact: Rohit Rao, MD    262-309-4874    rrao@phoenixchildrens.com   
Contact: Jennifer Matchey, MD    (602)909-3578    jmatchey@phoenixchildrens.com   
Principal Investigator: Rohit Rao, MD         
Sub-Investigator: Jennifer Matchey, MD         
Sponsors and Collaborators
Phoenix Children's Hospital
Investigators
Principal Investigator: Rohit Rao, MD Phoenix Children's Hospital
  More Information

Publications:

Responsible Party: Rohit Rao, M.D., Cardiac Intensivist, Phoenix Children's Hospital
ClinicalTrials.gov Identifier: NCT01577810     History of Changes
Other Study ID Numbers: PHNX-NIRS-12-024
Study First Received: March 23, 2012
Last Updated: June 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Phoenix Children's Hospital:
NIRS
near infrared spectroscopy
heart failure
cardiac output
outpatient
pediatric

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014