SpO2 Validation Study-Philips Optimus

Completed

• Conditions: Pulse Oximetry, Oxygen Measurements, SpO2

• Registration Number: NCT07215429
• Lead Sponsor: Philips Clinical & Medical Affairs Global

Brief Summary

Validation study to validate the SpO2 accuracy performance of the Sponsor's SpO2 sensors over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry

Detailed Description

The intent of this clinical study is to validate the SpO2 accuracy performance of the Sponsor's SpO2 sensors over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the Sponsor's pulse oximeter with consideration to anticipated updates to ISO 80601-2-61:2025(E)

Study Timeline

• Study First Submitted: 2025-09-08
• Study Start: 2025-09-09
• Primary Completion: 2025-09-19
• Study Completion: 2025-09-19
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-08
• Last Update Submitted: 2025-10-08
• Study First Posted: 2025-10-10
• Last Update Posted: 2025-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SpO2 accuracy of the SpO2 sensors under test with the Philips MRI Patient Monitoring	Day 1	Pulse Oximetry Subsystem during non-motion conditions over the range of 70-100% SaO2, when compared with the reference SaO2 obtained from CO-Oximetry analysis of arterial blood samples.

Secondary Outcome Measures

Name	Time	Method
evaluate non-disparate performance (differential bias) of the SpO2 sensors under test	Day 1	with the Philips MRI Patient Monitoring Pulse Oximetry Subsystem during non-motion conditions in the SaO2 ranges of 70% ≤ SaO2 ≤ 85% and 85% \< SaO2 ≤100%.; with the Philips MRI Patient Monitoring Pulse Oximetry Subsystem during non-motion conditions in the SaO2 ranges of 70% ≤ SaO2 ≤ 85% and 85% \< SaO2 ≤100%.; with the Philips MRI Patient Monitoring Pulse Oximetry Subsystem during non-motion conditions in the SaO2 ranges of 70% ≤ SaO2 ≤ 85% and 85% \< SaO2 ≤100%.

Trial Locations

Locations (1)

Element Materials Technology; 🇺🇸 Louisville, Colorado, United States