NCT02506010

Accuracy Validation of a Pulse Oximetry Monitor

SpO2 Accuracy Validation of a USB Pulse Oximetry Monitor Interface Cable Via Reference Co-Oximetry

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to conduct an oxygen saturation (SpO2) accuracy validation comparing prototype pulse oximeter oxygen saturation measurements directly to arterial blood saturation during non-motion conditions over the range of 60-100% SaO2 as measured by Reference CO-Oximetry. Additionally, the prototype pulse oximeter pulse rate measurements will be compared to 3-lead ECG heart rate measurements made via a multi-parameter monitor.

Detailed description

The description of this study is to conduct an oxygen saturation (SpO2) accuracy validation comparing prototype pulse oximeter oxygen saturation measurements directly to arterial blood saturation during non-motion conditions over the range of 60-100% SaO2 as measured by Reference CO-Oximetry. Additionally, the prototype pulse oximeter pulse rate measurements will be compared to 3-lead ECG heart rate measurements made via a multi-parameter monitor.

Conditions

• Healthy

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-07-22
• Last updated: 2016-10-18

Locations

1 site across 1 country: United States