Desaturation Validation of INVSENSOR00039

Completed

• Conditions: Healthy
• Interventions: Device: INVSENSOR00039

• 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

Arm && Interventions

Group	Intervention	Description
INVSENSOR00039	INVSENSOR00039	All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00039 sensor.

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