N/A
N=37
Validation of the O3 Regional Somatic Tissue Oxygenation Monitor
Oxygen Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT04584788 ↗Enrolled (actual)
37
Serious AEs
2.7%
Results posted
Jun 2022
Primary outcome: Primary: Accuracy of O3 Sensor by ARMS Calculation of Percent rSO2 — 4.78 percentage of regional oxygen saturation
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Masimo O3 Regional Oximeter (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of O3 Sensor by ARMS Calculation of Percent rSO2 |
4.78 | — |
Summary
Testing the absolute accuracy of the Masimo O3 regional oximeter in reading somatic tissue oxygenation in healthy volunteers under controlled hypoxia.
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
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.