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
  Purpose

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.


Condition Intervention
Cardiac Catheterization
Device: CAS NIRS FORE-SIGHT oximeter

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Validation of the CAS Medical System, Inc. FORE-SIGHT Near-Infrared Spectroscopy (NIRS) Monitor in Pediatric Subjects for Viscerosomatic Applications

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 180
Study Start Date: February 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Pediatric patients presenting for 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

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849940

Contacts
Contact: David MacLeod, FRCA 919-812-3201 david.macleod@duke.edu

Locations
United States, North Carolina
Duke University Health System Recruiting
Durham, North Carolina, United States, 27710
Contact: David B MacLeod, FRCA    919-812-3201    david.macleod@duke.edu   
Principal Investigator: David B MacLeod, FRCA         
Sponsors and Collaborators
Duke University
CAS Medical Systems, Inc.
Investigators
Principal Investigator: David B MacLeod, FCRA Duke University Health System
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00849940     History of Changes
Other Study ID Numbers: Pro00009391
Study First Received: January 22, 2009
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Spectroscopy
Near infrared
Oximetry
Hypoxemia
Tissue oxygenation
Pediatric

ClinicalTrials.gov processed this record on October 20, 2014