Validation of the O3 Regional Somatic Tissue Oxygenation Monitor
Not Applicable
Completed
- Conditions
- Oxygen Deficiency
- 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
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
- 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Site 1
🇳🇱Groningen, Netherlands
Site 1🇳🇱Groningen, Netherlands