NCT05245526

SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor

Validate SpO2 Accuracy of Noninvasive Stryker Disposable Pulse Oximeter Sensors With Hypoxia at Rest

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Stryker Sustainability Solutions · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the reprocessed sensors.

Detailed description

In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the participant breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer. It is required that the Accuracy Root Mean Square (ARMS) performance of the Stryker pulse oximetry sensors will meet a specification of +/-3% or better in non-motion conditions for the range of 70 - 100% SaO2 (typically, saturation is determined once with air breathing and then at one of 3 levels, e.g. 95%, 85%, and 75% saturation for about 30-60 seconds at each level), thereby demonstrating an acceptable SpO2 accuracy performance specification.

Conditions

• Healthy
• Hypoxia

Interventions

Type	Name	Description
DEVICE	STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS	Reprocessed noninvasive pulse oximeter sensors.

Timeline

• Start date: 2022-01-19
• Primary completion: 2022-01-20
• Completion: 2022-01-20
• First posted: 2022-02-18
• Last updated: 2023-03-20
• Results posted: 2023-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study