Clinical Trial: Validation of Next Generation INVOS NIRS Cerebral and Tissue Oximeter

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Validation of Next Generation INVOS NIRS Cerebral and Tissue Oximeter to Measure Cerebral and Somatic Tissue Oxygen Saturation in Healthy Volunteers

Brief Summary: The primary objective of the study is to validate that the production equivalent PM7100 System in conjunction with Adult Sensors (PMSENS71-A) meet product requirements for cerebral accuracy, cerebral trending accuracy, and somatic trending.

Detailed Summary:
Sponsor: Medtronic - MITG

Current Primary Outcome: Validate that the production equivalent PM7100 System in conjunction with Adult Sensors (PMSENS71-A) [ Time Frame: Data collected from individual participant over 4 hour timeframe. ]

INVOS regional hemoglobin oxygen saturation (rSO2) performance will be compared to the calculated global field saturation (fSO2) value obtained from simultaneous collected arterial and jugular venous blood samples for the cerebral site.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Medtronic - MITG

Dates:
Date Received: April 5, 2017
Date Started: May 15, 2017
Date Completion: July 14, 2017
Last Updated: April 20, 2017
Last Verified: April 2017