NCT03783780

Desaturation Validation of INVSENSOR00031

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Masimo Corporation · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation compared to reference values obtained by a laboratory blood gas analyzer. Arterial blood samples will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen concentration is approximately 70%. During the desaturation, the subject's hand and arm without the arterial line will be subjected to motion at various times during the study. The subject will then be returned to breathing room air.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	INVSENSOR00031	Noninvasive pulse oximeter sensor

Timeline

• Start date: 2018-12-11
• Primary completion: 2018-12-18
• Completion: 2018-12-18
• First posted: 2018-12-21
• Last updated: 2019-12-17
• Results posted: 2019-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study