Blood PressureNCT04506333
Validation of A&D UA-651 in Children
A study testing A&D UA-651 Blood Pressure Monitor and ADC 740-N Manual Sphygmomanometer in people with Blood Pressure, run by University of Louisiana Monroe at 1 site in United States.
Trial summary
This study will determine if the A\&D UA-651 blood pressure monitor is valid in children. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- A&D UA-651 Blood Pressure Monitor and ADC 740-N Manual Sphygmomanometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2020to Dec 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 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent permission
- Assent for participants aged 7-12
- Additional sequential selection criteria (described below)
Who cannot join
- Withdrawal of permission or assent
- Younger than 3 or older than 12 years of age
- Uncooperative participants, defined as refusing instructions from study personnel, coordinators, or observers
- Physical preclusion to taking blood pressure
- Participants who have any reference blood pressure measurement exceeding the 95th percentile plus 30mmHg for their age, sex, and height (urgent blood pressure level as defined by the American Academy of Pediatrics)
- Participants with systolic blood pressure difference of greater than 12mmHg or diastolic blood pressure difference of greater than 8mmHg between any two reference measurements
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- Sequential Selection Criteria:
- Participants will be selected sequentially during study events. Per ISO/ESH/AAMI standards, participants must meet the following characteristics:
- at least 30% male and 30% female
- at least 1/6 using each of the three available cuff sizes (small, medium, large)
- for each cuff size, at least 40% in the upper half of the arm circumference range and at least 40% in the lower half of the arm circumference range.
- If including a participant would require that additional participants be enrolled to meet the above criteria, that participant will not be included. For example, if only 2 small cuff participants are needed to complete the study, but a prospective participant would require a large cuff AND including that participant will require additional small or medium cuff participants to complete the study, then that prospective participant will not be included.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisiana Monroe College of Pharmacy
Monroe, Louisiana, 71201
Bryan J Donald, PharmD, 318-342-1903, donald@ulm.edu
About this study
Official title: Validation of the A&D UA-651 Oscillometric Blood Pressure Monitor in Children
This study will determine if the A\&D UA-651 blood pressure monitor is valid in children.
- Conditions
- Blood Pressure
- Being tested
- A&D UA-651 Blood Pressure Monitor, ADC 740-N Manual Sphygmomanometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A&D UA-651 Blood Pressure MonitorDevice
Test device to be validated.
ADC 740-N Manual SphygmomanometerDevice
Reference device. Meets or exceeds ANSI/AAMI/ISO 81060-1 as required by ISO/ESH/AAMI standards.
| Study group | Role | What they receive |
|---|---|---|
| Small Cuff | Experimental | Participants with an upper-arm circumference of 6.3-9.4" may be placed in the small cuff arm. Receives: Device: A&D UA-651 Blood Pressure Monitor; Device: ADC 740-N Manual Sphygmomanometer |
| Medium Cuff | Experimental | Participants with an upper-arm circumference of 9.0-14.6" may be placed in the medium cuff arm. Receives: Device: A&D UA-651 Blood Pressure Monitor; Device: ADC 740-N Manual Sphygmomanometer |
| Lage Cuff | Experimental | Participants with an upper-arm circumference of 12.2-17.7" may be placed in the large cuff arm.
The large cuff arm will use an adaptive study design. Per the AAMI/ESH/ISO standards, at least 1/6 of participants must fall into each cuff size arm for that cuff size, and of the participants assigned to each cuff size, at least 40% of those must fall in the upper and lower half of the cuff's size range. However, we do not anticipate many participants in our age range falling in the upper half of the large cuff size range (upper arm circumference > 14.95").
Because of this, our plan is to validate the large cuff, but if enrolling a patient with a large cuff would require additional patients be enrolled to reach 1/6 of the total sample, the large cuff will be dropped from consideration and the validation completed with only the small and medium cuffs. Receives: Device: A&D UA-651 Blood Pressure Monitor; Device: ADC 740-N Manual Sphygmomanometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Triplet
A valid set of 3 measurements (reference-test-reference) will be considered one outcome measurement for validation.
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study startAug 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- The ISO/ESH/AAMI standards for validating blood pressure measurement devices will be used. In this model, participants' blood pressures are taken alternating between the test device and a reference device.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisiana Monroe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bryan J Donald, PharmD, Principal investigator, University of Louisiana Monroe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506333
- Sponsor's protocol ID
- 1017
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2020
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stergiou GS, Palatini P, Asmar R, Ioannidis JP, Kollias A, Lacy P, McManus RJ, Myers MG, Parati G, Shennan A, Wang J, O'Brien E; European Society of Hypertension Working Group on Blood Pressure Monitoring. Recommendations and Practical Guidance for performing and reporting validation studies according to the Universal Standard for the validation of blood pressure measuring devices by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO). J Hypertens. 2019 Mar;37(3):459-466. doi: 10.1097/HJH.0000000000002039.
PubMed 30702492
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the A&D UA-651 Oscillometric Blood Pressure Monitor in Children
- ClinicalTrials.gov ID
- NCT04506333
- Acronym / sponsor ID
- 1017
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Louisiana MonroeUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 Aug 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.
This study will determine if the A\&D UA-651 blood pressure monitor is valid in children.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The ISO/ESH/AAMI standards for validating blood pressure measurement devices will be used. In this model, participants' blood pressures are taken alternating between the test device and a reference device.
| Arm | Type | Receives |
|---|---|---|
| Small Cuff | Experimental | Device: A&D UA-651 Blood Pressure Monitor, Device: ADC 740-N Manual SphygmomanometerParticipants with an upper-arm circumference of 6.3-9.4" may be placed in the small cuff arm. |
| Medium Cuff | Experimental | Device: A&D UA-651 Blood Pressure Monitor, Device: ADC 740-N Manual SphygmomanometerParticipants with an upper-arm circumference of 9.0-14.6" may be placed in the medium cuff arm. |
| Lage Cuff | Experimental | Device: A&D UA-651 Blood Pressure Monitor, Device: ADC 740-N Manual SphygmomanometerParticipants with an upper-arm circumference of 12.2-17.7" may be placed in the large cuff arm. The large cuff arm will use an adaptive study design. Per the AAMI/ESH/ISO standards, at least 1/6 of participants must fall into each cuff size arm for that cuff size, and of the participants assigned to each cuff size, at least 40% of those must fall in the upper and lower half of the cuff's size range. However, we do not anticipate many participants in our age range falling in the upper half of the large cuff size range (upper arm circumference > 14.95"). Because of this, our plan is to validate the large cuff, but if enrolling a patient with a large cuff would require additional patients be enrolled to reach 1/6 of the total sample, the large cuff will be dropped from consideration and the validation completed with only the small and medium cuffs. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Parent permission
- Assent for participants aged 7-12
- Additional sequential selection criteria (described below)
Key exclusion criteria (12 listed)
- Withdrawal of permission or assent
- Younger than 3 or older than 12 years of age
- Uncooperative participants, defined as refusing instructions from study personnel, coordinators, or observers
- Physical preclusion to taking blood pressure
- Participants who have any reference blood pressure measurement exceeding the 95th percentile plus 30mmHg for their age, sex, and height (urgent blood pressure level as defined by the American Academy of Pediatrics)
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 UA-651 Blood Pressure MonitorTest device to be validated. | Device | Lage Cuff, Medium Cuff, Small Cuff |
| ADC 740-N Manual SphygmomanometerReference device. Meets or exceeds ANSI/AAMI/ISO 81060-1 as required by ISO/ESH/AAMI standards. | Device | Lage Cuff, Medium Cuff, Small Cuff |
Primary outcome
Blood Pressure Triplet
Time frame: Immediate
A valid set of 3 measurements (reference-test-reference) will be considered one outcome measurement for validation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Background: PubMed 30702492Stergiou GS, Palatini P, Asmar R, Ioannidis JP, Kollias A, Lacy P, McManus RJ, Myers MG, Parati G, Shennan A, Wang J, O'Brien E; European Society of Hypertension Working Group on Blood Pressure Monitoring. Recommendations and Practical Guidance for performing and reporting validation studies according to the Universal Standard for the validation of blood pressure measuring devices by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO). J Hypertens. 2019 Mar;37(3):459-466. doi: 10.1097/HJH.0000000000002039.
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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.
Bryan J Donald, PharmD principal investigator
University of Louisiana Monroe
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 UA-651 Blood Pressure Monitor and ADC 740-N Manual Sphygmomanometer in people with Blood Pressure, run by University of Louisiana Monroe 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 3 inclusion and 12 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 10 Aug 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bryan J Donald, PharmD (318-342-1903, donald@ulm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure Triplet (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04506333, which also lists 1 linked publication.
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 Aug 2020.