Assessing the Accuracy of the A&D TM-2657W Oscillometric Device
NCT ID: NCT04238442
Last Updated: 2020-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
121 participants
INTERVENTIONAL
2019-08-14
2020-02-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The investigators plan to use the existing International Standards Organization validation protocol to determine whether this device measures blood pressure accurately.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Validation of Wrist Type Oscillometric Blood Pressure Monitorings
NCT04633785
Accuracy Testing of Validated and Non-validated Home BP Devices Sold on the Online Market.
NCT06688409
Validation Study of CONTEC08C Electronic Sphygmomanometer
NCT06457568
Comparison of Non-Invasive Blood Pressure Methods
NCT04296227
Blood Pressure Monitor (KD-595) Clinical Test (Cuff Range: 15-24cm, 22-42cm, 40-48cm)
NCT07094126
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BP oscillometric measurement
Oscillometric BP measurement
A&D TM-2657W oscillometric device
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
A&D TM-2657W oscillometric device
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* normal sinus rhythm
* have capacity to give consent
* following the International Standards Organization criteria for: gender distribution, limb size, blood pressure distribution
Exclusion Criteria
* pregnancy
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
A&D Medical
UNKNOWN
University of Alberta
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jennifer Ringrose, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alberta
Edmonton, Alberta, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00079695
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.