Validation of the O3 Regional Somatic Tissue Oxygenation Monitor

Masimo

Status: Completed

Conditions: Oxygen Deficiency

Treatments: Device: Masimo O3 Regional Oximeter

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04584788

SCHE0001

Details and patient eligibility

About

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

Enrollment: 37 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Healthy Adult Volunteers

Experimental group

Description:

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.

Treatment:

Device: Masimo O3 Regional Oximeter