N/A Completed N=37 Other

Validation of the O3 Regional Somatic Tissue Oxygenation Monitor

Oxygen Deficiency

Source: ClinicalTrials.gov NCT04584788 ↗

Enrolled (actual)

Serious AEs

2.7%

Results posted

Jun 2022

Primary outcomePrimary: Accuracy of O3 Sensor by ARMS Calculation of Percent rSO2 — 4.78 percentage of regional oxygen saturation

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Accuracy of O3 Sensor by ARMS Calculation of Percent rSO2	4.78	—

Eligibility Criteria

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 sourced from ClinicalTrials.gov (NCT04584788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.