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Near Infrared Spectroscopy (NIRS) for Heart Failure Assessment.

Primary Purpose

Cardiac Failure

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Near Infrared Spectroscopy
Sponsored by
Phoenix Children's Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Failure focused on measuring NIRS, near infrared spectroscopy, heart failure, cardiac output, outpatient, pediatric

Eligibility Criteria

1 Day - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient in Phoenix Children's Hospital Heart Failure Clinic

Exclusion Criteria:

  • N/A

Sites / Locations

  • Phoenix Children's Hospital Heart Failure ClinicRecruiting

Outcomes

Primary Outcome Measures

Degree of Heart Failure using NIRS
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.

Secondary Outcome Measures

Full Information

First Posted
March 23, 2012
Last Updated
June 6, 2013
Sponsor
Phoenix Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01577810
Brief Title
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

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Phoenix Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Failure
Keywords
NIRS, near infrared spectroscopy, heart failure, cardiac output, outpatient, pediatric

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Near Infrared Spectroscopy
Other Intervention Name(s)
NIRs, INVOS
Intervention Description
Use of Near Infrared Spectroscopy in outpatient setting to determine global cardiac output
Primary Outcome Measure Information:
Title
Degree of Heart Failure using NIRS
Description
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.
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient in Phoenix Children's Hospital Heart Failure Clinic Exclusion Criteria: N/A
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rohit Rao, MD
Phone
(262)309-4874
Email
rrao@phoenixchildrens.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Matchey, MD
Phone
(602)9093578
Email
jmatchey@phoenixchildrens.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rohit Rao, MD
Organizational Affiliation
Phoenix Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital Heart Failure Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rohit Rao, MD
Phone
262-309-4874
Email
rrao@phoenixchildrens.com
First Name & Middle Initial & Last Name & Degree
Jennifer Matchey, MD
Phone
(602)909-3578
Email
jmatchey@phoenixchildrens.com
First Name & Middle Initial & Last Name & Degree
Rohit Rao, MD
First Name & Middle Initial & Last Name & Degree
Jennifer Matchey, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
15033888
Citation
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
2877225
Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Near Infrared Spectroscopy (NIRS) for Heart Failure Assessment.

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