NCT03704636

Desaturation Validation of INVSENSOR00028

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Masimo Corporation · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is designed to measure the trending accuracy of a noninvasive regional oximetry measurement of somatic oxygen saturation. Two large sensors (adult sensors) will be placed on the subject's forehead. Two investigational sensors (INVSENSOR00028) will be placed on the forearm of the volunteer. The values obtained by the INVSENSOR00028 will be compared to the reference value calculated from the arterial and venous blood measurements. Data 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 saturation is approximately 70%, while blood samples are drawn at prespecified reference points. The subject will then be returned to inhaling room air.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	INVSENSOR00028	Noninvasive pulse oximeter sensor

Timeline

• Start date: 2018-09-25
• Primary completion: 2018-10-24
• Completion: 2018-10-24
• First posted: 2018-10-15
• Last updated: 2021-07-15
• Results posted: 2021-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study