Prospective, observational, pre-market, verification study to confirm accuracy of the INVOS 7100 system in compliance with ISO 80601-2-85:2021 standard
Verify that the INVOS PM7100 system in conjunction with the INVOS Adult Sensors meets the requirements for tissue saturation accuracy.
Study Type
OBSERVATIONAL
Enrollment
48
The study objectives require placement of a jugular venous bulb catheter and radial arterial line placement with ultrasound guidance. Two INVOS™ sensors (PMSENS71-A) will be placed bilaterally on the subject's forehead and two on the calf. 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 Medical Center
Durham, North Carolina, United States
Accuracy in terms of the root mean square error
Performance assessed by comparing INVOS™ rSO2 to the calculated global field saturation (fSO2) value obtained from simultaneous arterial and jugular venous blood samples during normocapnia.
Time frame: Performance evaluation is expected take approximately 2.5 hours
Trend accuracy
* Cerebral site: Complete system in conjunction with an adult sensor (model PMSENS71-A) shall have an rSO2 trending accuracy over the declared range of 50% to 85% compared to reference hemoglobin tissue oxygen saturation. * Somatic site: System shall be able to calculate rSO2 on somatic sites.
Time frame: Evaluation is expected take approximately 2.5 hours
Trend accuracy in a hypercapneic state
Device performance will be evaluated during hypercapnia
Time frame: Evaluation is expected take approximately 2.5 hours
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