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Validation of Brain Oxygenation Monitor on Pediatric Patients

NCT00849940 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2017-02-09

Study results available
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Summary

The aim of this study is calibrate (adjust and tune) the CAS FORE-SIGHT Near-Infrared Spectroscopy (NIRS) monitor when used to measure the tissue oxygen saturation of internal organs (StO2). This is a measure of the amount of oxygen carried by the blood within the internal organs. In addition the study will assess the degree of similarities between StO2 and mean mixed venous oxygen saturation - a measure of the amount of oxygen carried in the blood returning to the heart.

Conditions

  • Cardiac Catheterization

Interventions

DEVICE

CAS NIRS FORE-SIGHT oximeter

Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation.

Sponsors & Collaborators

  • CAS Medical Systems, Inc.

    collaborator INDUSTRY

  • Duke University

    lead OTHER

Principal Investigators

  • David B MacLeod, FCRA · Duke Health

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00849940 on ClinicalTrials.gov