CareTaker Respiratory Rate Detection Study
- Conditions
- Respiration Rate Detection
- Registration Number
- NCT02942836
- Lead Sponsor
- CareTaker Medical LLC
- Brief Summary
The goal of the proposed study is to test the capability of the CareTaker monitor to extract the respiration signature from its acquired signal, and to determine a respiration rate of breaths/minute that meets or exceeds the performance levels of its predicate device.
- Detailed Description
The goal of the proposed study is to test the capability of the CareTaker monitor to extract the respiration signature from its acquired signal, and to determine a respiration rate of breaths/minute that meets or exceeds the performance levels of its predicate device.
The detection approach of RSPR (respiratory rate) that the CareTaker technology takes is based on peak detection and pulse analysis of arterial pressure pulse signals, as well as spectral analysis of the raw CareTaker sensor signal.
The study was performed under the supervision of the Chesapeake IRB and involved 21 subjects \>18 y who were monitored during spontaneous and metronome-paced breathing.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- > 18 years of age, who are able and willing to participate and have given verbal assent
- Unable to give written consent
- <18 years of age
- No or poor finger pulse, as determined through visual inspection for ischemic hands
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Respiration rate detection with accuracy of better than 3 breaths per minute 15 minutes of matched respiration rates Comparison with performance of predicate device (accuracy within 3 breaths per minute).
- Secondary Outcome Measures
Name Time Method