Validation of Brain Oxygenation Monitor on Pediatric Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Duke University
Sponsor:
Collaborator:
CAS Medical Systems, Inc.
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00849940
First received: January 22, 2009
Last updated: February 11, 2014
Last verified: February 2014

January 22, 2009
February 11, 2014
February 2009
December 2014   (final data collection date for primary outcome measure)
Accuracy of sensor [ Time Frame: Data collected from individual participants over 4 hour timeframe. Data from cohort of subjects collected over 24 month period. ] [ Designated as safety issue: No ]
Correlation between displayed tissue sensor value and measured blood values of tissue oxygen saturation, from which the degree of sensor accuracy is derived.
Accuracy of device to measure cerebral tissue oxygen saturation [ Time Frame: One day ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00849940 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Validation of Brain Oxygenation Monitor on Pediatric Patients
Validation of the CAS Medical System, Inc. FORE-SIGHT Near-Infrared Spectroscopy (NIRS) Monitor in Pediatric Subjects for Viscerosomatic Applications

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.

NIRS cerebral oximeters are FDA-approved devices used to measure oxygen saturation within the brain, in a similar manner to pulse oximeters that measure the oxygen saturation in the finger tip. The sensor pads are placed on the surface of the forehead and shine near-infrared light through the skull and brain tissue from which the brain tissue oxygen saturation is estimated. The same principles can be applied when the sensor pads are placed over the internal organs of the abdomen, for example, the liver. Currently the only way to accurately measure the oxygen saturation of internal organs is by the invasive placement of intravenous lines into the blood vessels of that organ. This study will determine if the NIRS sensors can reliably estimate the tissue oxygen saturation non-invasively by placing the pad over the skin of the abdomen.

The study will be conducted in pediatric patients who are undergoing cardiac catheterization, a procedure in which invasive lines are placed in order to get information about the heart. The procedure is always conducted under general anesthesia. During the cardiac catheterization procedure blood samples are routinely taken for oxygen saturation analysis. In the study two oximeter sensor pads will be placed on the forehead (one on each side) and two further oximeter sensor pads will be placed on the abdominal wall. The oxygen saturation values from all oximeter sensors will be recorded continuously throughout the cardiac catheterization procedure and will be compared to the oxygen saturation values from the blood samples. In addition to the routine blood samples taken as part of the cardiac catheterization, one blood sample will be taken when the invasive line is within the right hepatic (liver) vein.

The information from this study will determine how well the oximeter sensors estimate the oxygen saturation of both the internal organs (StO2) and the blood returning to the heart (mean mixed venous oxygen saturation).

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Cardiac Catheterization
Device: CAS NIRS FORE-SIGHT oximeter
Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation.
Other Name: CAS NIRS FORE-SIGHT oximeter
Experimental: 1
Pediatric patients presenting for cardiac catheterization.
Intervention: Device: CAS NIRS FORE-SIGHT oximeter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
December 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Known structural neurologic or craniofacial disease
  • Arterial catheter placement not part of planned catheterization procedure
  • Anemia (hemoglobin < 10 g/dl)
Both
up to 17 Years
No
Contact: David MacLeod, FRCA 919-812-3201 david.macleod@duke.edu
United States
 
NCT00849940
Pro00009391
No
Duke University
Duke University
CAS Medical Systems, Inc.
Principal Investigator: David B MacLeod, FCRA Duke University Health System
Duke University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP