Accuracy Verification of the INVOS PM7100

Not yet recruitingOBSERVATIONAL
Enrollment

38

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

March 31, 2026

Conditions
Tissue Oxygenation
Interventions
DEVICE

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.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Medtronic - MITG

INDUSTRY

NCT07166341 - Accuracy Verification of the INVOS PM7100 | Biotech Hunter | Biotech Hunter