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Near Infrared Spectroscopy (NIRS) for Heart Failure Assessment.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by Rohit Rao, M.D., Phoenix Children's Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Rohit Rao, M.D., Phoenix Children's Hospital Identifier:
First received: March 23, 2012
Last updated: June 6, 2013
Last verified: June 2013
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: 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 Rohit Rao, M.D., Phoenix Children's Hospital:

Primary Outcome 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.

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.

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information


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
Study First Received: March 23, 2012
Last Updated: June 6, 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 processed this record on June 23, 2017