Validation of the O3 Regional Somatic Tissue Oxygenation Monitor

Masimo Corporation37 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Oxygen Deficiency

Interventions

Masimo O3 Regional OximeterDEVICE

Study sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Site 1

Groningen, Netherlands

Outcomes

Primary Outcomes

Accuracy of O3 Sensor by ARMS Calculation of Percent rSO2

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).

Time frame: 1 visit up to 8 hours

Data from ClinicalTrials.gov

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