NCT06581835

Accuracy Performance Verification of the INVOS™ PM7100 System in Adults

Accuracy Performance Verification of the INVOS™ PM7100 System by Comparing rSO2 Values to Reference Blood Oxygen Saturation Measurements in Adult Human Volunteers

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Prospective, observational, post-market, verification study to ensure compliance to the ISO 80601-2-85:2021 standard

Detailed description

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.

Conditions

• Oxygen Saturation

Interventions

Type	Name	Description
DEVICE	Observational	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.

Timeline

• Start date: 2024-10-21
• Primary completion: 2025-03-20
• Completion: 2025-07-22
• First posted: 2024-09-03
• Last updated: 2025-07-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study