RespirationNCT00827905
Substantial Equivalence Study for Kai Sensors RSpot Non-Contact Respiratory Rate Spot Check
An observational study of Respiration, run by Kai Medical, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the respiratory rate provided by the Kai Sensors RSpot 100 Non-Contact Respiratory Rate Spot Check is as accurate as that provided by the Welch Allyn Propaq Encore model 242 and the Embla Embletta system with Universal XactTrace respiratory effort sensor and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiration
- What is being tested?
- RSpot Non-Contact Respiratory Rate Spot Check
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jan 2009
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients Hospitalized at the Queen's Medical Center in Honolulu, HI
Who may be able to join
- Adult >18 years old
- Hospitalized on Tower 6 or Pauahi 6 or Pauahi 4
- Clinically stable
- Able to provide informed consent
Who cannot join
- Clinically unstable
- Hypotensive requiring pressors or intra-aortic balloon pump
- Intubated
- Dyspnea or chest pain at rest
- Resting tachycardia (heart rate >100 bpm)
- Requires supplemental (e.g., nasal canula or face mask) oxygen
- Scheduled or planned (e.g., CT scan, central line placement) procedure during the 30 minute study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Doppler System to Measure Heart Rate and Breathing Pattern
The purpose of this study is to determine whether the respiratory rate provided by the Kai Sensors RSpot 100 Non-Contact Respiratory Rate Spot Check is as accurate as that provided by the Welch Allyn Propaq Encore model 242 and the Embla Embletta system with Universal XactTrace respiratory effort sensor and Somnologica for Embletta software.
Read the detailed description
Currently, medical professionals obtain respiratory rate for vital signs assessments either by counting the number of breaths during a 15, 30, or 60 second interval and multiplying to obtain breaths per minute, or by reading the respiratory rate off of a multiparameter vital signs monitor (such as a Welch Allyn Propaq Monitor), that provides respiratory effort information based on the change of AC impedance through ECG leads. The Respiration channel (RESP) of the Welch Allyn Propaq is intended to detect the rate or absence of respiratory effort, deriving the signal by measuring the AC impedance between the selected terminals of the ECG electrodes. The RSpot 100 Non-Contact Respiratory Rate Spot Check provides an alternative to the medical professional counting respiratory rate or reading the rate from a vital signs monitor designed for continuous respiratory rate monitoring. The Kai Sensors RSpot 100 Non-Contact Respiratory Rate Spot Check is used for a one-time measurement of respiratory rate as part of a vital signs assessment in the hospital or other clinical settings.
In this study, the RSpot is operated simultaneously with two other systems that provide a respiratory rate: Welch Allyn Propaq Encore model 242 and Embletta system with Universal XactTrace and Somnologica software. A respiratory rate is also obtained by counting respiratory excursions for the same duration as the RSpot measurement interval, 15, 30, or 60 seconds. The rates obtained from each of the four measurement methods are then compared.
- Conditions
- Respiration
- Being tested
- RSpot Non-Contact Respiratory Rate Spot Check
- Keywords
- Non-Contact, Radar, Respiratory, Respiration, Breathing, Rate, Frequency, Respiratory Mechanics, Respiratory Rate Measurement
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSpot Non-Contact Respiratory Rate Spot CheckDevice
Also called KaiSpot, RSpot 100, RSpot, Non-Contact Respiratory Rate Spot Check
The Kai Sensors RSpot 100 provides a measurement of respiratory rate at a single point in time. It uses a low-power radar to detect respiratory effort, and analyzes the respiratory effort signal to provide a respiratory rate.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized | Patients admitted to the hospital Receives: Device: RSpot Non-Contact Respiratory Rate Spot Check |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RespirationStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kai Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Todd Seto, MD, Principal investigator, The Queen's Medical CenterOlga Boric-Lubecke, PhD, Study director, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827905
- Sponsor's protocol ID
- KAI-00003
- Other IDs
- RA-2008-061
- Status last verified
- Aug 2010
- First submitted
- 21 Jan 2009
- Last updated
- 6 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Doppler System to Measure Heart Rate and Breathing Pattern
- ClinicalTrials.gov ID
- NCT00827905
- Acronym / sponsor ID
- KAI-00003
- Conditions
- Respiration
- Keywords
- Non-Contact, Radar, Respiratory, Respiration, Breathing, Rate, Frequency, Respiratory Mechanics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kai Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 23 Jan 2009 (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 purpose of this study is to determine whether the respiratory rate provided by the Kai Sensors RSpot 100 Non-Contact Respiratory Rate Spot Check is as accurate as that provided by the Welch Allyn Propaq Encore model 242 and the Embla Embletta system with Universal XactTrace respiratory effort sensor and Somnologica for Embletta software.
Detailed description
Currently, medical professionals obtain respiratory rate for vital signs assessments either by counting the number of breaths during a 15, 30, or 60 second interval and multiplying to obtain breaths per minute, or by reading the respiratory rate off of a multiparameter vital signs monitor (such as a Welch Allyn Propaq Monitor), that provides respiratory effort information based on the change of AC impedance through ECG leads. The Respiration channel (RESP) of the Welch Allyn Propaq is intended to detect the rate or absence of respiratory effort, deriving the signal by measuring the AC impedance between the selected terminals of the ECG electrodes. The RSpot 100 Non-Contact Respiratory Rate Spot Check provides an alternative to the medical professional counting respiratory rate or reading the rate from a vital signs monitor designed for continuous respiratory rate monitoring. The Kai Sensors RSpot 100 Non-Contact Respiratory Rate Spot Check is used for a one-time measurement of respiratory rate as part of a vital signs assessment in the hospital or other clinical settings.
In this study, the RSpot is operated simultaneously with two other systems that provide a respiratory rate: Welch Allyn Propaq Encore model 242 and Embletta system with Universal XactTrace and Somnologica software. A respiratory rate is also obtained by counting respiratory excursions for the same duration as the RSpot measurement interval, 15, 30, or 60 seconds. The rates obtained from each of the four measurement methods are then compared.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized | – | Device: RSpot Non-Contact Respiratory Rate Spot CheckPatients admitted to the hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients Hospitalized at the Queen's Medical Center in Honolulu, HI
Key inclusion criteria (4 listed)
- Adult >18 years old
- Hospitalized on Tower 6 or Pauahi 6 or Pauahi 4
- Clinically stable
- Able to provide informed consent
Key exclusion criteria (7 listed)
- Clinically unstable
- Scheduled or planned (e.g., CT scan, central line placement) procedure during the 30 minute study period
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 |
|---|---|---|
| RSpot Non-Contact Respiratory Rate Spot CheckAlso: KaiSpot, RSpot 100, RSpot, Non-Contact Respiratory Rate Spot CheckThe Kai Sensors RSpot 100 provides a measurement of respiratory rate at a single point in time. It uses a low-power radar to detect respiratory effort, and analyzes the respiratory effort signal to provide a respiratory rate. | Device | Hospitalized |
Primary outcome
Not reported in the source record.
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 6 Aug 2010.
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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.
Todd Seto, MD principal investigator
The Queen's Medical Center
Olga Boric-Lubecke, PhD study director
University of Hawaii
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiration, run by Kai Medical, Inc. at 1 site in United States.
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 4 inclusion and 7 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 6 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 6 Aug 2010.