We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Validation of Brain Oxygenation Monitor on Pediatric Patients

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00849940
First Posted: February 24, 2009
Last Update Posted: February 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
CAS Medical Systems, Inc.
Information provided by (Responsible Party):
Duke University
  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: None (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 NIRS Sensor to Estimate Flank Tissue Oxygen Saturation [ Time Frame: Data collected from individual participants over 4 hour timeframe. ]

    The flank tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of flank tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the flank tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other.

    oxygen saturation when measured displayed NIRS value of the tissue sensor placed over the flank to a reference CO-oximetry model, reported as bias and precision. The model is weighted as 30:70 arterial: central venous oxygen saturation when measured by blood gas co-oximetry.


  • Accuracy of NIRS Sensor to Estimate Intestine Tissue Oxygen Saturation [ Time Frame: Data collected from individual participants over 4 hour timeframe. ]
    The intestine tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of intestine tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the intestine tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other.

  • Accuracy of NIRS Sensor to Estimate Hepatic Tissue Oxygen Saturation [ Time Frame: Data collected from individual participants over 4 hour timeframe. ]
    The hepatic tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of hepatic tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the hepatic tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other.


Secondary Outcome Measures:
  • Correlation Between Somatic StO2 and Cerebral SctO2 Oxygen Saturation [ Time Frame: Data collected from individual participants over 4 hour timeframe ]
  • Correlation Between NIRS Derived Estimate of Hemoglobin Concentration and Measured Arterial Blood Hemoglobin Concentration. [ Time Frame: Data collected from individual participants over 4 hour timeframe ]

Enrollment: 72
Study Start Date: February 2009
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CAS NIRS FORE-SIGHT oximeter
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.

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00849940


Locations
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
CAS Medical Systems, Inc.
Investigators
Principal Investigator: David B MacLeod, FCRA Duke University Health System
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00849940     History of Changes
Other Study ID Numbers: Pro00009391
First Submitted: January 22, 2009
First Posted: February 24, 2009
Results First Submitted: November 9, 2015
Results First Posted: March 28, 2016
Last Update Posted: February 9, 2017
Last Verified: February 2016

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