A Single-Center, Prospective Study in Healthy Subjects to Validate a New OXYGEN RESERVE INDEX (ORI)
Recruiting
- Conditions
- zuurstofspanning en zuurstof saturatie bij gezonde vrijwilligersOxygen Reserve Indexpressure of O2
- Registration Number
- NL-OMON41998
- Lead Sponsor
- MASIMO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
•Age between 18 and 45 years
•Written informed consent
•Healthy subjects
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Validation of the new Oxygen Reserve Index (ORI) by collecting optical data<br /><br>using the Rainbow SET Pulse CO-Oximeter (Masimo Corp.) and comparing them to<br /><br>whole blood references of arterial and venous blood drawn in healthy<br /><br>volunteers.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Determination and quantification of the capability of the new Oxygen Reserve<br /><br>Index (ORI) to serve as an early alarm of changes in patient*s oxygen status<br /><br>• Quantification of the effects of changes in inspired oxygen concentration on<br /><br>o cerebral tissue oxygenation (as obtained by near infrared spectroscopy, NIRS).<br /><br>o peripheral tissue oxygenation (as obtained by NIRS).</p><br>