Desaturation Validation of INVSENSOR00039

Completed

• Conditions: Healthy

• Registration Number: NCT04112784
• Lead Sponsor: Masimo Corporation

Brief 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. The subject will then be returned to breathing room air.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-17
• Study First Submitted: 2019-09-30
• Study First Submitted QC: 2019-09-30
• Study First Posted: 2019-10-02
• Primary Completion: 2019-10-09
• Study Completion: 2019-10-09
• Disposition First Submitted: 2020-09-11
• Disposition First Submitted QC: 2020-09-11
• Status Verified: 2022-09
• Results First Submitted: 2022-09-08
• Results First Submitted QC: 2022-09-08
• Last Update Submitted: 2022-09-08
• Results First Posted: 2022-10-06
• Disposition First Posted: 2022-10-06
• Last Update Posted: 2022-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Oxygen Saturation (SpO2) Accuracy of Sensor	1-5 hours	Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Accuracy root square mean (ARMS) value.

Trial Locations

Locations (1)

Masimo Corporation; 🇺🇸 Irvine, California, United States