Clinical validation of vital signs measured by the Vital Signs Monitoring System in a controlled environment
Completed
- Conditions
- n.v.t.n/a
- Registration Number
- NL-OMON50709
- Lead Sponsor
- FastFocus B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
- Aged 18 to 50 years old
- ASA category 1: a normal healthy subject. Example: fit, nonobese (BMI under
30), non-smoking with good exercise tolerance
- No hypertension
Exclusion Criteria
- Inability to give informed consent
- At risk during hypoxia due to medical conditions (e.g. cardiovascular or
pulmonary disease)
- Pregnant or braestfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is the accuracy of the device under investigation to<br /><br>determine functional oxygen saturation as compared to a reference device and to<br /><br>determine respiratory rate as compared to visual observations.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary outcome is the accuracy of the device under investigation to<br /><br>determine respiratory rate compared to a reference device.</p><br>