Respiration Rate Detection
Conditions
Keywords
Respiration Rate Detection
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.
Interventions
DEVICEnon-intrusive respiration monitor
Equivalence of CareTaker's respiration rate detection capability to that of predicate device
Sponsors
CareTaker Medical LLC
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Outcome results
None listed