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Validation of Brain Oxygenation Monitor on Pediatric Patients

This study has been terminated.
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 24, 2016
Last verified: February 2016
Results First Received: November 9, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Cardiac Catheterization
Cardiac Catheterization [E01.370.370.380.140]
Intervention: Device: CAS NIRS FORE-SIGHT oximeter

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
CAS NIRS FORE-SIGHT Oximeter

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.


Participant Flow:   Overall Study
    CAS NIRS FORE-SIGHT Oximeter
STARTED   72 
COMPLETED   68 
NOT COMPLETED   4 
Physician Decision                4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CAS NIRS FORE-SIGHT Oximeter

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.


Baseline Measures
   CAS NIRS FORE-SIGHT Oximeter 
Overall Participants Analyzed 
[Units: Participants]
 72 
Age 
[Units: Participants]
 
<=18 years   72 
Between 18 and 65 years   0 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   34 
Male   38 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   0 
Not Hispanic or Latino   66 
Unknown or Not Reported   6 
Region of Enrollment 
[Units: Participants]
 
United States   72 


  Outcome Measures
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1.  Primary:   Accuracy of NIRS Sensor to Estimate Flank Tissue Oxygen Saturation   [ Time Frame: Data collected from individual participants over 4 hour timeframe. ]

2.  Primary:   Accuracy of NIRS Sensor to Estimate Intestine Tissue Oxygen Saturation   [ Time Frame: Data collected from individual participants over 4 hour timeframe. ]

3.  Primary:   Accuracy of NIRS Sensor to Estimate Hepatic Tissue Oxygen Saturation   [ Time Frame: Data collected from individual participants over 4 hour timeframe. ]

4.  Secondary:   Correlation Between Somatic StO2 and Cerebral SctO2 Oxygen Saturation   [ Time Frame: Data collected from individual participants over 4 hour timeframe ]

5.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Blood samples collected from pediatric patients undergoing cardiac catheterization. Venous blood samples taken from within IVC as close to the tissue of interest.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David MacLeod, M.B.
Organization: Duke University Medical Center
phone: 919-681-3551
e-mail: david.macleod@dm.duke.edu



Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00849940     History of Changes
Other Study ID Numbers: Pro00009391
Study First Received: January 22, 2009
Results First Received: November 9, 2015
Last Updated: February 24, 2016
Health Authority: United States: Institutional Review Board