A Single-Center, Prospective Study in Healthy Volunteers for Validation of the O3 Regional Somatic Tissue Oxygenation Monitor
Completed
- Conditions
- Anesthesiology, validation of non-invasive equipment in healthy volunteersregional tissue oxygenationshortness of oxygen
- Registration Number
- NL-OMON49641
- Lead Sponsor
- MASIMO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
* Age between 18 and 45 years
* Willing and able to provide written informed consent
* Healthy volunteer
Exclusion Criteria
* Pregnant women (female subjects will have a pregnancy test prior to being
admitted to the study).
* 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
* Volunteer 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
- Not specified
- Primary Outcome Measures
Name Time Method <p>The agreement between Masimo O3 derived somatic tissue rSO2 and invasively<br /><br>determined somatic oxygenation values (SaO2 / SvO¬2, 30:70 ratio).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Evaluation of the association between SvO2 values derived from the tip of the<br /><br>catheter in the renal vein, and from the femoral vein.</p><br>