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Accuracy Verification of the INVOS PM7100
Sponsor: Medtronic - MITG
Summary
Prospective, observational, pre-market, verification study to confirm accuracy of the INVOS 7100 system in compliance with ISO 80601-2-85:2021 standard
Official title: Accuracy Performance Verification of the INVOS™ PM7100 System, Comparing rSO2 Values to Reference Blood Oxygen Saturation Measurements in Adult Human Volunteers
Key Details
Gender
All
Age Range
18 Years - 46 Years
Study Type
OBSERVATIONAL
Enrollment
48
Start Date
2025-09-29
Completion Date
2026-04-24
Last Updated
2026-01-13
Healthy Volunteers
Yes
Conditions
Interventions
Observational
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.
Locations (1)
Duke University Medical Center
Durham, North Carolina, United States