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Accuracy of CardioWatch 287-2 During Profound Hypoxia — ACW2  

Hypoxia Clinical Trial

Official title:
Accuracy of CardioWatch 287-2 During Profound Hypoxia

Clinical Trial Summary

In an individual's SpO2 range from 100 to 73 %, this study calibrates and evaluates the accuracy of SpO2 measurement by CW2 in comparison to reference pulse oximeter (Nellcor PM10) or CO-oximetry, Pulse rate (PR) and respiratory rate (RR) were calibrated based on the same Nellcor equipment and the frequency of end-tidal CO2 respectively.

Clinical Trial Description

The study is designed in accordance with Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment ISO 80601-2-61:2017, Corrected version 2018-02 and ISO 80601-2-55. SpO2: Testing to confirm the accuracy of the SpO2 monitoring according to ISO 80601-2-61 Clause 201.12.1.101 201.12.1.101 RR Testing: Testing to confirm the accuracy of the respiration rate monitoring according to ISO 80601-2-55. Volunteers respirated spontaneously, no efforts were made to include all ranges of respiration during the study. PR Testing: Testing to confirm the accuracy of the PR monitoring according to ISO 80601-2-61 Clause 201.12.1.104. No efforts were made to influence PRs of volunteers. An accelerometer and PPG filters are built in CW2 in order to form the basis to exclude non-eligible test results. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05542732
Study type Interventional
Source Corsano Health B.V.
Contact
Status Completed
Phase N/A
Start date June 4, 2022
Completion date June 27, 2022
View Details
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