Respiration Rate DetectionRSPNCT02942836
CareTaker Respiratory Rate Detection Study
An observational study of Respiration Rate Detection, run by CareTaker Medical LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiration Rate Detection
- What is being tested?
- non-intrusive respiration monitor
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects were local health club members, > 18 years of age, who were able and willing to participate and willing to sign the written consent
Who may be able to join
- > 18 years of age, who are able and willing to participate and have given verbal assent
Who cannot join
- Unable to give written consent
- <18 years of age
- No or poor finger pulse, as determined through visual inspection for ischemic hands
About this study
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.
Read the 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
- Respiration Rate Detection
- Being tested
- non-intrusive respiration monitor
- Keywords
- Respiration Rate Detection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-intrusive respiration monitorDevice
Equivalence of CareTaker's respiration rate detection capability to that of predicate device
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiration rate detection with accuracy of better than 3 breaths per minute
Comparison with performance of predicate device (accuracy within 3 breaths per minute).
Measured: 15 minutes of matched respiration rates
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration Rate DetectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- CareTaker Medical LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin C Baruch, PhD, Principal investigator, CareTaker Medical LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942836
- Sponsor's protocol ID
- RSP_001
- Acronym
- RSP
- Status last verified
- Oct 2016
- First submitted
- 20 Oct 2016
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CareTaker Respiratory Rate Detection Study
- ClinicalTrials.gov ID
- NCT02942836
- Acronym / sponsor ID
- RSP / RSP_001
- Conditions
- Respiration Rate Detection
- Keywords
- Respiration Rate Detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- CareTaker Medical LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects were local health club members, > 18 years of age, who were able and willing to participate and willing to sign the written consent
Key inclusion criteria (1 listed)
- > 18 years of age, who are able and willing to participate and have given verbal assent
Key exclusion criteria (3 listed)
- Unable to give written consent
- <18 years of age
- No or poor finger pulse, as determined through visual inspection for ischemic hands
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-intrusive respiration monitorEquivalence of CareTaker's respiration rate detection capability to that of predicate device | Device | – |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin C Baruch, PhD principal investigator
CareTaker Medical LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Respiration Rate Detection, run by CareTaker Medical LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiration rate detection with accuracy of better than 3 breaths per minute (time frame: 15 minutes of matched respiration rates). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2016; AzTrials last refreshed its copy on 1 Nov 2026.