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COMPLETEDNANCT04584788

Validation of the O3 Regional Somatic Tissue Oxygenation Monitor

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

Lead sponsor: Masimo Corporation•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Masimo Corporation

Collaborators

University Medical Center Groningen

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 27, 2022Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment37

Start dateNov 2020

Last updatedJun 27, 2022

Condition

Oxygen Deficiency

Locations shown

Site 1

Groningen

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2022Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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