At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Post-Launch Hypoxia Clinical Study Protocol for Reprocessed Masimo RD SET Pulse Oximeters With Motion
In Brief
A clinical study evaluating Experimental Masimo RD SET SpO2 Adhesive Sensors for Healthy and Hypoxia. Completed, enrolled 11 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Masimo RD SET SpO2 Adhesive Sensors, Adult (4000 Adt), Adult \& Neonate (4003 Neo)