Validation of the O3 Regional Somatic Tissue Oxygenation Monitor

Not Applicable

Completed

• Conditions: Oxygen Deficiency
• Interventions: Device: Masimo O3 Regional Oximeter

• Registration Number: NCT04584788
• Lead Sponsor: Masimo Corporation

Brief Summary

Testing the absolute accuracy of the Masimo O3 regional oximeter in reading somatic tissue oxygenation in healthy volunteers under controlled hypoxia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-06
• Study First Posted: 2020-10-14
• Study Start: 2020-11-30
• Primary Completion: 2021-06-02
• Study Completion: 2021-06-02
• Status Verified: 2022-05
• Results First Submitted: 2022-05-31
• Results First Submitted QC: 2022-05-31
• Last Update Submitted: 2022-05-31
• Results First Posted: 2022-06-27
• Last Update Posted: 2022-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Age between 18 and 45 years, inclusive
• Willing and able to provide written informed consent
• Healthy subjects

Exclusion Criteria

• Pregnant women
• Presence of any cardiovascular or pulmonary disease
• Exposure to high altitude(s) (>2000 m) within 30 days prior to the study
• Known allergy to intravenous contrast medium or heparin
• Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent monitoring of SpO2 levels during the study
• Patients deemed not suitable for the study at the discretion of the Investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Adult Volunteers	Masimo O3 Regional Oximeter	Controlled hypoxia will be induced and Masimo O3 regional oximeter-derived tissue oxygen saturation (rSO2) readings of somatic tissue will be measured. The readings will be compared with blood reference oxygen saturation values.

Primary Outcome Measures

Name	Time	Method
Accuracy of O3 Sensor by ARMS Calculation of Percent rSO2	1 visit up to 8 hours	Accuracy of the sensors will be determined by comparing somatic regional oxygen saturation (rSO2) readings from the O3 sensor and blood reference oxygen saturation values and calculating the Arithmetic root mean square (ARMS).

Trial Locations

Locations (1)

Site 1; 🇳🇱 Groningen, Netherlands