Validation of Brain Oxygenation Monitor on Pediatric Patients

Stopped early · Not applicable

Conditions studied: Cardiac Catheterization

In brief

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.

Key facts

Study ID

NCT00849940

Run by

Duke University

People needed

72

Starts

2009-02-01

Expected to finish

2014-11-01

Last updated by the study team

2017-02-09

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≤ 18 years old
• ≥ 2.5 kg and ≤ 40 kg weight
• Undergoing cardiac catheterization at Duke pediatric cardiac catheterization laboratory

You may not qualify if…

• Known structural neurologic or craniofacial disease
• Arterial catheter placement not part of planned catheterization procedure
• Anemia (hemoglobin < 10 g/dl)

Where it is running

• Duke University Health System — Durham, North Carolina, United States
• Duke University Health System — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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