Accuracy Performance Verification of the INVOS™ PM7100 System in Adults

CompletedOBSERVATIONAL
Enrollment

42

Participants

Timeline

Start Date

October 21, 2024

Primary Completion Date

March 20, 2025

Study Completion Date

July 22, 2025

Conditions
Oxygen Saturation
Interventions
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.

Trial Locations (1)

27705

Duke University, Durham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Medtronic - MITG

INDUSTRY

NCT06581835 - Accuracy Performance Verification of the INVOS™ PM7100 System in Adults | Biotech Hunter | Biotech Hunter