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Near Infrared Spectroscopy (NIRS) for Heart Failure Assessment.

Near Infrared Spectroscopy (NIRS) for Heart Failure Assessment in the Outpatient Setting

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01577810
Enrollment
3
Registered
2012-04-16
Start date
2013-06-30
Completion date
2017-04-05
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Failure

Keywords

NIRS, near infrared spectroscopy, heart failure, cardiac output, outpatient, pediatric

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.

Interventions

DEVICENear Infrared Spectroscopy

Use of Near Infrared Spectroscopy in outpatient setting to determine global cardiac output

Sponsors

Phoenix Children's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

Only the investigator knew the assignment.

Intervention model description

The NIRS monitoring in the heart center was not able to be completed.

Eligibility

Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No

Inclusion criteria

* Patient in Phoenix Children's Hospital Heart Failure Clinic

Exclusion criteria

* N/A

Design outcomes

Primary

MeasureTime frameDescription
Degree of Heart Failure using NIRS5 minutesThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026