Trials / Completed
CompletedNCT02942836
CareTaker Respiratory Rate Detection Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 21 (actual)
- Sponsor
- CareTaker Medical LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | non-intrusive respiration monitor | Equivalence of CareTaker's respiration rate detection capability to that of predicate device |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2016-06-01
- Completion
- 2016-06-01
- First posted
- 2016-10-24
- Last updated
- 2016-10-24
Source: ClinicalTrials.gov record NCT02942836. Inclusion in this directory is not an endorsement.