Blood PressureNCT04238442
Assessing the Accuracy of the A&D TM-2657W Oscillometric Device
A study testing A&D TM-2657W oscillometric device in people with Blood Pressure, run by University of Alberta at 1 site in Canada.
Trial summary
The A\&D automatic blood pressure device is a new kiosk that can measure blood pressure in the general population. The investigators plan to use the existing International Standards Organization validation protocol to determine whether this device measures blood pressure accurately. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- A&D TM-2657W oscillometric device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteCanada
- Study dates
- 14 Aug 2019to 5 Feb 2020
- Phase
- Interventional
- 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
Who may be able to join
- 18 years of age or older
- normal sinus rhythm
- have capacity to give consent
- following the International Standards Organization criteria for: gender distribution, limb size, blood pressure distribution
Who cannot join
- atrial fibrillation
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The A\&D automatic blood pressure device is a new kiosk that can measure blood pressure in the general population.
The investigators plan to use the existing International Standards Organization validation protocol to determine whether this device measures blood pressure accurately.
Read the detailed description
Methods and Analysis
Study methodology will follow the ISO protocol:
- 85 adult (age 18 years or greater) subjects will be included (it is estimated that approximately 140 subjects will need to be screened as some will be ineligible). 85 is the recommended sample size for validation studies using the ISO protocol.
- Subjects will be recruited via an existing registry of over 250 individuals that have participated in past measurement studies, through advertisements, and from the University of Alberta Hypertension Clinic.
- Specific requirements for a certain percentage of subjects with specific age, sex, upper arm circumference, and baseline blood pressure levels will be observed to ensure that a representative sample is studied (according to the ISO standards).
- Subjects that are pregnant or with atrial fibrillation will be excluded. Blood pressure measurements will be taken using recommended, optimal technique.
- Nine measurements will be taken in each subject, alternating between blinded two-observer auscultation with a mercury-based sphygmomanometer (the reference standard) and the TM-2657. Careful attention will be paid to ensuring proper cuffing. The first two measurements will be discarded and the latter seven measurements (4 auscultatory and TM-2657 measurements) will be used in the analysis, which will be conducted according to ISO standards.
- Accuracy will be assessed according to Criterion 1 and 2 of the ISO standard. Bland-Altman plots will be generated. A plot of measurement error versus arm circumference will be generated as well.
- Conditions
- Blood Pressure
- Being tested
- A&D TM-2657W oscillometric device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A&D TM-2657W oscillometric deviceDevice
Assessing the accuracy of the A\&D TM-2657W oscillometric device using International Standards Organization validation protocol. This involves comparing the accuracy of the A\&D device to 2 observer mercury auscultation (gold standard).
| Study group | Role | What they receive |
|---|---|---|
| BP oscillometric measurement | Experimental | Oscillometric BP measurement Receives: Device: A&D TM-2657W oscillometric device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy per International Standards Organization Protocol
Agreement of the device to mercury auscultation.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start14 Aug 2019
- Primary completion5 Feb 2020
- Study completion5 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- A&D Medical
- Responsible party
- Sponsor
- Investigators
- Jennifer Ringrose, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238442
- Sponsor's protocol ID
- Pro00079695
- Status last verified
- Apr 2020
- First submitted
- 1 Oct 2019
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Accuracy of the A&D TM-2657W Oscillometric Device
- ClinicalTrials.gov ID
- NCT04238442
- Acronym / sponsor ID
- Pro00079695
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- A&D Medical
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 23 Jan 2020 (actual)
- 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 A\&D automatic blood pressure device is a new kiosk that can measure blood pressure in the general population.
The investigators plan to use the existing International Standards Organization validation protocol to determine whether this device measures blood pressure accurately.
Detailed description
Methods and Analysis
Study methodology will follow the ISO protocol:
- 85 adult (age 18 years or greater) subjects will be included (it is estimated that approximately 140 subjects will need to be screened as some will be ineligible). 85 is the recommended sample size for validation studies using the ISO protocol.
- Subjects will be recruited via an existing registry of over 250 individuals that have participated in past measurement studies, through advertisements, and from the University of Alberta Hypertension Clinic.
- Specific requirements for a certain percentage of subjects with specific age, sex, upper arm circumference, and baseline blood pressure levels will be observed to ensure that a representative sample is studied (according to the ISO standards).
- Subjects that are pregnant or with atrial fibrillation will be excluded. Blood pressure measurements will be taken using recommended, optimal technique.
- Nine measurements will be taken in each subject, alternating between blinded two-observer auscultation with a mercury-based sphygmomanometer (the reference standard) and the TM-2657. Careful attention will be paid to ensuring proper cuffing. The first two measurements will be discarded and the latter seven measurements (4 auscultatory and TM-2657 measurements) will be used in the analysis, which will be conducted according to ISO standards.
- Accuracy will be assessed according to Criterion 1 and 2 of the ISO standard. Bland-Altman plots will be generated. A plot of measurement error versus arm circumference will be generated as well.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BP oscillometric measurement | Experimental | Device: A&D TM-2657W oscillometric deviceOscillometric BP measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- normal sinus rhythm
- have capacity to give consent
- following the International Standards Organization criteria for: gender distribution, limb size, blood pressure distribution
Key exclusion criteria (2 listed)
- atrial fibrillation
- pregnancy
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 |
|---|---|---|
| A&D TM-2657W oscillometric deviceAssessing the accuracy of the A\&D TM-2657W oscillometric device using International Standards Organization validation protocol. This involves comparing the accuracy of the A\&D device to 2 observer mercury auscultation (gold standard). | Device | BP oscillometric measurement |
Primary outcome
Accuracy per International Standards Organization Protocol
Time frame: 3 months
Agreement of the device to mercury auscultation.
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 10 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Jennifer Ringrose, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A&D TM-2657W oscillometric device in people with Blood Pressure, run by University of Alberta at 1 site in Canada.
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 2 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 10 Apr 2020. 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 Canada. 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.
What does the primary outcome measure?
Accuracy per International Standards Organization Protocol (time frame: 3 months). 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 10 Apr 2020.