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Validation of Near Infrared Spectroscopy (NIRS) During Heart-Lung Bypass in Children

NCT00745394 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-01-24

No results posted yet for this study

Summary

Non-invasive assessment of blood flow to organs has long challenged clinicians. Recently, near infrared spectroscopy (NIRS) has been recognized as a methodology that may achieve this goal. A commercially available NIRS monitor, marketed by Somanetics, Inc., is now in widespread use in the clinical care of pediatric cardiac patients in the operating room and in the intensive care unit post-operatively. When a patch/probe from the monitor is placed on the forehead or lower back, blood oxygen concentration data is obtained which has been found to correlate with actual blood samples taken by IV. The presence of this NIRS data would give the surgeon important feedback about blood flow to important areas like the brain and kidneys during heart surgeries on children and after the operation is completed in the intensive care unit.

The investigator wishes to perform a prospective study of the NIRS monitor use with children that need heart surgeries that require heart-lung bypass and sometimes require monitoring in the ICU, post-operatively.

Conditions

  • Cardiopulmonary Bypass

Sponsors & Collaborators

  • Children's Medical Center Dallas

    collaborator OTHER

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Joseph Forbess, MD · Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-08-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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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 NCT00745394 on ClinicalTrials.gov