Respiratory Rate Accuracy Test
Conditions
Keywords
Respiratory Rate
Brief summary
The purpose of this study is to validate the accuracy of the Perminova N4 Monitoring system Respiration Rate technology.
Detailed description
After IRB Approval, eighteen volunteer test subjects will be entered into an accuracy study that is designed to validate accuracy of the respiratory rate technology of the Perminova N4 Monitoring system (Device Under Test). The subjects will be selected to represent a range of body types including small, average, muscular, and large with a range of BMI's. A range of stable respiratory rates will be elicited from each volunteer test subject. The rates will be approximately 5, 10, 15, 20, 25, 30, 35 and 40 breaths per minute; with some natural variation from these exact numbers. Each subject will be instrumented with an open system mask that allows for measurement of the end tidal carbon dioxide (EtCO2) respiratory rate and tidal volume. The EtCO2 monitor will be used as the Accuracy Reference Device (Reference) in this study. Performance of the currently released ECG Impedance Respiratory Rate monitor (Acceptance Standard) will be used to establish the acceptance criteria in this study by comparing to Reference.
Interventions
None listed
Sponsors
Clinimark, LLC
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* male * female * 18-45 * range of physiques * healthy
Exclusion criteria
* injury to sensor area * skin inflammation * implanted devices such as pacemakers * pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Respiratory Rate of test subject as compared to end tidal CO2 | 1 week |
Countries
United States
Outcome results
None listed