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
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2020-08-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Small Cuff
Participants with an upper-arm circumference of 6.3-9.4" may be placed in the small cuff arm.
A&D UA-651 Blood Pressure Monitor
Test device to be validated.
ADC 740-N Manual Sphygmomanometer
Reference device. Meets or exceeds ANSI/AAMI/ISO 81060-1 as required by ISO/ESH/AAMI standards.
Medium Cuff
Participants with an upper-arm circumference of 9.0-14.6" may be placed in the medium cuff arm.
A&D UA-651 Blood Pressure Monitor
Test device to be validated.
ADC 740-N Manual Sphygmomanometer
Reference device. Meets or exceeds ANSI/AAMI/ISO 81060-1 as required by ISO/ESH/AAMI standards.
Lage Cuff
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.
A&D UA-651 Blood Pressure Monitor
Test device to be validated.
ADC 740-N Manual Sphygmomanometer
Reference device. Meets or exceeds ANSI/AAMI/ISO 81060-1 as required by ISO/ESH/AAMI standards.
Interventions
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A&D UA-651 Blood Pressure Monitor
Test device to be validated.
ADC 740-N Manual Sphygmomanometer
Reference device. Meets or exceeds ANSI/AAMI/ISO 81060-1 as required by ISO/ESH/AAMI standards.
Eligibility Criteria
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Inclusion Criteria
* Assent for participants aged 7-12
* Additional sequential selection criteria (described below)
Exclusion Criteria
* 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
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.
3 Years
12 Years
ALL
Yes
Sponsors
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University of Louisiana Monroe
OTHER
Responsible Party
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Principal Investigators
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Bryan J Donald, PharmD
Role: PRINCIPAL_INVESTIGATOR
University of Louisiana Monroe
Locations
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University of Louisiana Monroe College of Pharmacy
Monroe, Louisiana, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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1017
Identifier Type: -
Identifier Source: org_study_id
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