Blood PressureNCT04633785
Validation of Wrist Type Oscillometric Blood Pressure Monitorings
An observational study of Blood Pressure, run by Taipei Veterans General Hospital, Taiwan.
Trial summary
Since the wrist devices have the advantage of being smaller, lighter, and more inexpensive than the upper arm devices, wrist devices become increasingly popular. However, it is of utmost importance to ensure that the BP measuring device can measure BP accurately. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 30 Jun 2021
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients will be recruited from outpatient clinics at Taipei Veterans General Hospital from 2020 to 2021. A total of 100 subjects will be enrolled in the study, and informed consent forms will be obtained from before measurements. In accordance with the ANSI/AAMI/ISO, subjects will be screened to ensure that sex, age, wrist circumference, and BP readings fulfilled the participation requirements described in those protocols. If subjects aged less than 12 years old, having wrist circumference outside of the designated range (13.5-23 cm), having arrhythmias, who moved their arms or bodies during the BP measurements, and have unclear Korotkoff sounds will be excluded from this study.
Who may be able to join
- above 12 years old
Who cannot join
- unclear Korotkoff sounds
- wrist circumference outside of the designated range (13.5-23 cm)
- arrhythmias
Trial locations and contacts
No sites are listed yet.
About this study
Since the wrist devices have the advantage of being smaller, lighter, and more inexpensive than the upper arm devices, wrist devices become increasingly popular. However, it is of utmost importance to ensure that the BP measuring device can measure BP accurately. This study will be aimed to validate a wrist type oscillometric blood pressure monitoring with reference to the brachial blood pressure measured by auscultatory method with a mercury sphygmomanometer.
Read the detailed description
High blood pressure (BP) is one of the major cardiovascular risk factors in adults. Home blood pressure monitoring is superior to office-based measurements for prediction of the future development of cardiovascular diseases and is recommended by major guidelines. To monitor BP at home, patients can use devices that measure BP either at the arm or at the wrist.
Among BP monitors, the wrist device is relatively easy to use, as the cuff can be used with one hand easily and correctly around the wrist than around the arm, and undressing is not necessary. Since the wrist devices have the advantage of being smaller, lighter, and more inexpensive than the upper arm devices, wrist devices become increasingly popular. However, it is of utmost importance to ensure that the BP measuring device can measure BP accurately. To make sure the performance of these devices, several guidelines have proposed protocols to validate these devices. This study will be aimed to validate a wrist type oscillometric blood pressure monitoring with reference to the brachial blood pressure measured by auscultatory method with a mercury sphygmomanometer.
- Conditions
- Blood Pressure
- Being tested
- No Intervention
- Keywords
- oscillometric, wrist blood pressure monitor, sphygmomanometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
There are no interventions in this study. The mercury sphygmomanometer and the wrist sphygmomanometer will be used in this study to collect blood pressure values from the study subjects.
| Study group | Role | What they receive |
|---|---|---|
| wrist BP | Not described Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation
The present study will be aimed to evaluate the accuracy of the wrist type oscillometric blood pressure monitorings.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
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 Taipei Veterans General Hospital, TaiwanThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hao-Min Cheng, M.D., Ph.D., Study director, Center for Evidence-based Medicine, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633785
- Sponsor's protocol ID
- 2020-11-001CC
- Status last verified
- Nov 2020
- First submitted
- 11 Nov 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Wrist Type Oscillometric Blood Pressure Monitorings
- ClinicalTrials.gov ID
- NCT04633785
- Acronym / sponsor ID
- 2020-11-001CC
- Conditions
- Blood Pressure
- Keywords
- oscillometric, wrist blood pressure monitor, sphygmomanometer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 18 Nov 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.
Since the wrist devices have the advantage of being smaller, lighter, and more inexpensive than the upper arm devices, wrist devices become increasingly popular. However, it is of utmost importance to ensure that the BP measuring device can measure BP accurately. This study will be aimed to validate a wrist type oscillometric blood pressure monitoring with reference to the brachial blood pressure measured by auscultatory method with a mercury sphygmomanometer.
Detailed description
High blood pressure (BP) is one of the major cardiovascular risk factors in adults. Home blood pressure monitoring is superior to office-based measurements for prediction of the future development of cardiovascular diseases and is recommended by major guidelines. To monitor BP at home, patients can use devices that measure BP either at the arm or at the wrist.
Among BP monitors, the wrist device is relatively easy to use, as the cuff can be used with one hand easily and correctly around the wrist than around the arm, and undressing is not necessary. Since the wrist devices have the advantage of being smaller, lighter, and more inexpensive than the upper arm devices, wrist devices become increasingly popular. However, it is of utmost importance to ensure that the BP measuring device can measure BP accurately. To make sure the performance of these devices, several guidelines have proposed protocols to validate these devices. This study will be aimed to validate a wrist type oscillometric blood pressure monitoring with reference to the brachial blood pressure measured by auscultatory method with a mercury sphygmomanometer.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| wrist BP | – | Other: No Intervention |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be recruited from outpatient clinics at Taipei Veterans General Hospital from 2020 to 2021. A total of 100 subjects will be enrolled in the study, and informed consent forms will be obtained from before measurements. In accordance with the ANSI/AAMI/ISO, subjects will be screened to ensure that sex, age, wrist circumference, and BP readings fulfilled the participation requirements described in those protocols. If subjects aged less than 12 years old, having wrist circumference outside of the designated range (13.5-23 cm), having arrhythmias, who moved their arms or bodies during the BP measurements, and have unclear Korotkoff sounds will be excluded from this study.
Key inclusion criteria (1 listed)
- above 12 years old
Key exclusion criteria (3 listed)
- unclear Korotkoff sounds
- wrist circumference outside of the designated range (13.5-23 cm)
- arrhythmias
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 |
|---|---|---|
| No InterventionThere are no interventions in this study. The mercury sphygmomanometer and the wrist sphygmomanometer will be used in this study to collect blood pressure values from the study subjects. | Other | wrist BP |
Primary outcome
Validation
Time frame: 7 months
The present study will be aimed to evaluate the accuracy of the wrist type oscillometric blood pressure monitorings.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 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.
Hao-Min Cheng, M.D., Ph.D. study director
Center for Evidence-based Medicine, Taipei Veterans General Hospital, Taiwan
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by Taipei Veterans General Hospital, Taiwan.
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: status not confirmed, as of the sponsor's last update on 18 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao-Min Cheng, M.D., Ph.D. ((886)-2-28757302 ext. 307, hmcheng@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation (time frame: 7 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 18 Nov 2020.