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

Withdrawn before enrolling

Conditions studied: Cardiopulmonary Bypass

In brief

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.

Key facts

Study ID: NCT00745394
Run by: University of Texas Southwestern Medical Center
People needed: 0
Starts: 2008-04-01
Expected to finish: 2008-12-31
Last updated by the study team: 2025-01-24

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

1. Patients that require cardiopulmonary bypass during surgical correction of heart disease
2. Prospective, Informed Consent

You may not qualify if…

1. Patients with malformations of venous return to the heart (e.g. interrupted IVC with azygous continuation).

Where it is running

Children's Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.