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Clinical Trial Summary

Noninvasive measurement of cerebral tissue oxygen saturation levels by near infrared spectroscopy (NIRS) is clinical routine in perioperative medicine. One of the main technical challenges of NIRS measurements is to eliminate the influence of signals of the skin and skull. A new device (RheoPatch, Luciole Medical AG, Zurich) has been developed by a company that also developed an intracranial NIRS probe, which allowed measurements directly in the brain and thus improved algorithms for elimination of the extracranial signals. The investigators aim to determine baseline values and performance of the new device (RheoPatch) compared with a more established NIRS device (NIRO-200NX, Hamamatsu Phototonics, Hamamatsu City, Japan)


Clinical Trial Description

Primary objective is to compare the RheoPatch NIRS device with the NIRO-200NX NIRS device in volunteers at rest in supine position. As secondary objectives, repeatability of the measurements will be tested with optode reapplications. With measurements in Trendelenburg position, the investigators evaluate the influence of body (head) position on the NIRS signals. Primary outcome are the baseline values of cerebral oxygenation levels measured by RheoPatch (SbtO2 (%)) and NIRO-200NX (Tissue oxygenation index: TOI (%)). Secondary endpoints are the repeatability of the measurements with sensor reapplications (coefficient of repeatability, 5 repeats with each device) and changes of the measurements of cerebral oxygenation saturation level in the Trendelenburg position. Measurements of baseline cerebral oxygenation values are obtained in supine position with 10 measurements, alternating between devices. Combined with 5 min measurement phase for equilibration and power adjustment, this will require 33 minutes per participant. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05460585
Study type Observational
Source University Hospital Inselspital, Berne
Contact
Status Completed
Phase
Start date June 1, 2022
Completion date May 10, 2023

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