NCT06149416

SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor With Motion Conditions

Post-Launch Hypoxia Clinical Study Protocol for Reprocessed Masimo RD SET Pulse Oximeters With Motion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Stryker Sustainability Solutions · Industry
• Sex: All
• Age: 18 Years – 50 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 motion conditions over the range of 70 -100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry during conditions in which the subject is moving. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the reprocessed sensors with motion indications.

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 study volunteer 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. A machine will be used to induce motions of 20 mm during testing at a sine rate of 2Hz, 3Hz, and 4Hz. A third motion moves the arm a random distance of 0 to 30mm at a random speed up to 5Hz. It is required that the Accuracy Root Mean Square (ARMS) performance of the Stryker pulse oximetry sensors will meet a specification of +/-3% with a target of +/-3% or better in motion conditions for the range of 70 - 100% SaO2 (typically, saturation is determined once with air breathing and then at three or six levels, e.g. 94%, 90%, 85%, 80%, 75% and 70% or 95%, 85% and 75% saturation for about 30-60 seconds or 60-90 seconds at each level), thereby demonstrating an acceptable SpO2 accuracy performance specification. This study should utilize a three level structure (95%, 85% and 75%).

Conditions

• Healthy
• Hypoxia

Interventions

Type	Name	Description
DEVICE	Experimental Masimo RD SET SpO2 Adhesive Sensors	Masimo RD SET SpO2 Adhesive Sensors, Adult (4000 Adt), Adult \& Neonate (4003 Neo)

Timeline

• Start date: 2023-05-27
• Primary completion: 2023-05-28
• Completion: 2023-05-28
• First posted: 2023-11-29
• Last updated: 2025-06-06
• Results posted: 2025-06-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study