Prospective, observational, post-market, verification study to ensure compliance to the ISO 80601-2-85:2021 standard
The purpose of this study is to provide data for verification of the INVOS™ PM7100 System paired with the Adult Sensor (PMSENS71-A). Medtronic evaluates the performance and/or feasibility of non-invasive optical devices over a clinically relevant range of arterial saturations. This study evaluates rSO2 accuracy of tissue oximetry equipment compared directly to the actual saturation of arterial and jugular blood samples (SaO2) and (SjvO2) and the composite of the two (SavO2) as measured by co-oximetry.
Study Type
OBSERVATIONAL
Enrollment
42
The study objective requires placement of a jugular venous bulb catheter in the right or left jugular venous bulb with ultrasound guidance. A venous and radial arterial line will be placed. Two INVOS™ sensors (PMSENS71-A) will be placed bilaterally on the subject's forehead. The INVOS™ device will be evaluated for a targeted range of 70-100% SpO2 levels. Hypoxic mixtures of gas are delivered, and data are collected at approximately (\~) 5-minute intervals during steady periods of increasing and decreasing oxygen concentration.
Duke University
Durham, North Carolina, United States
Accuracy root mean square
Accuracy root mean square is the square-root of the average squared distances between regional oxygen saturation (rSO2) as measured by INVOS and and field saturation (fSO2) as measured by blood sampling
Time frame: rSO2 and fSO2 data are recorded every 5-minutes during the procedure
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