CareTaker Respiratory Rate Detection Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Respiration Rate Detection
- Sponsor
- CareTaker Medical LLC
- Enrollment
- 21
- Primary Endpoint
- Respiration rate detection with accuracy of better than 3 breaths per minute
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\> 18 years of age, who are able and willing to participate and have given verbal assent
Exclusion Criteria
- •Unable to give written consent
- •\<18 years of age
- •No or poor finger pulse, as determined through visual inspection for ischemic hands
Outcomes
Primary Outcomes
Respiration rate detection with accuracy of better than 3 breaths per minute
Time Frame: 15 minutes of matched respiration rates
Comparison with performance of predicate device (accuracy within 3 breaths per minute).