Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Validation of Brain Oxygenation Monitor on Pediatric Patients

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.
 
ClinicalTrials.gov Identifier: NCT00849940
Recruitment Status : Terminated
First Posted : February 24, 2009
Results First Posted : March 28, 2016
Last Update Posted : February 9, 2017
Sponsor:
Collaborator:
CAS Medical Systems, Inc.
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Cardiac Catheterization
Intervention Device: CAS NIRS FORE-SIGHT oximeter
Enrollment 72
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CAS NIRS FORE-SIGHT Oximeter
Hide Arm/Group Description

Pediatric patients presenting for cardiac catheterization.

CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation.

Period Title: Overall Study
Started 72
Completed 68
Not Completed 4
Reason Not Completed
Physician Decision             4
Arm/Group Title CAS NIRS FORE-SIGHT Oximeter
Hide Arm/Group Description

Pediatric patients presenting for cardiac catheterization.

CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation.

Overall Number of Baseline Participants 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
<=18 years
72
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
Female
34
  47.2%
Male
38
  52.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
66
  91.7%
Unknown or Not Reported
6
   8.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 72 participants
72
1.Primary Outcome
Title Accuracy of NIRS Sensor to Estimate Flank Tissue Oxygen Saturation
Hide Description

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.

Time Frame Data collected from individual participants over 4 hour timeframe.
Hide Outcome Measure Data
Hide Analysis Population Description
Weight range 3.9 - 49.5 kg; age 0.2 - 12.3 years represent the values of the participants analyzed.
Arm/Group Title CAS NIRS FORE-SIGHT Oximeter
Hide Arm/Group Description:

Pediatric patients presenting for cardiac catheterization.

CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation.

Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: percentage of oxygen saturation
-0.67  (4.88)
2.Primary Outcome
Title Accuracy of NIRS Sensor to Estimate Intestine Tissue Oxygen Saturation
Hide Description 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.
Time Frame Data collected from individual participants over 4 hour timeframe.
Hide Outcome Measure Data
Hide Analysis Population Description
Weight 2.9 - 24.0 kg; age 0.04 - 9.8 years represent the values of the participants analyzed.
Arm/Group Title CAS NIRS FORE-SIGHT Oximeter
Hide Arm/Group Description:

Pediatric patients presenting for cardiac catheterization.

CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation.

Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: percentage of oxygen saturation
1.57  (4.41)
3.Primary Outcome
Title Accuracy of NIRS Sensor to Estimate Hepatic Tissue Oxygen Saturation
Hide Description 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.
Time Frame Data collected from individual participants over 4 hour timeframe.
Hide Outcome Measure Data
Hide Analysis Population Description
Weight 2.9 - 25.4 kg; age 0.04 - 10.2 years represent the values of the participants analyzed.
Arm/Group Title CAS NIRS FORE-SIGHT Oximeter
Hide Arm/Group Description:

Pediatric patients presenting for cardiac catheterization.

CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation.

Overall Number of Participants Analyzed 63
Mean (Standard Deviation)
Unit of Measure: percentage of oxygen saturation
0.04  (5.63)
4.Secondary Outcome
Title Correlation Between Somatic StO2 and Cerebral SctO2 Oxygen Saturation
Hide Description [Not Specified]
Time Frame Data collected from individual participants over 4 hour timeframe
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title CAS NIRS FORE-SIGHT Oximeter
Hide Arm/Group Description:

Pediatric patients presenting for cardiac catheterization.

CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Correlation Between NIRS Derived Estimate of Hemoglobin Concentration and Measured Arterial Blood Hemoglobin Concentration.
Hide Description [Not Specified]
Time Frame Data collected from individual participants over 4 hour timeframe
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title CAS NIRS FORE-SIGHT Oximeter
Hide Arm/Group Description:

Pediatric patients presenting for cardiac catheterization.

CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CAS NIRS FORE-SIGHT Oximeter
Hide Arm/Group Description

Pediatric patients presenting for cardiac catheterization.

CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation.

All-Cause Mortality
CAS NIRS FORE-SIGHT Oximeter
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CAS NIRS FORE-SIGHT Oximeter
Affected / at Risk (%)
Total   0/72 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CAS NIRS FORE-SIGHT Oximeter
Affected / at Risk (%)
Total   0/72 (0.00%) 
Blood samples collected from pediatric patients undergoing cardiac catheterization. Venous blood samples taken from within IVC as close to the tissue of interest.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David MacLeod, M.B.
Organization: Duke University Medical Center
Phone: 919-681-3551
EMail: david.macleod@dm.duke.edu
Layout table for additonal 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