Validation of A&D UA-651 in Children

Study Overview
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Brief Summary
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This study will determine if the A&D UA-651 blood pressure monitor is valid in children.

Official Title
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Validation of the A&D UA-651 Oscillometric Blood Pressure Monitor in Children

Conditions
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Blood Pressure

Intervention / Treatment
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* Device: A&D UA-651 Blood Pressure Monitor
* Device: ADC 740-N Manual Sphygmomanometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parent permission Assent for participants aged 7-12 Additional sequential selection criteria (described below) Exclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Small Cuff<br>Participants with an upper-arm circumference of 6.3-9.4 may be placed in the small cuff arm. | Device: A&D UA-651 Blood Pressure Monitor<br>* Test device to be validated.<br>Device: ADC 740-N Manual Sphygmomanometer<br>* Reference device. Meets or exceeds ANSI/AAMI/ISO 81060-1 as required by ISO/ESH/AAMI standards.<br>|
| Experimental: Medium Cuff<br>Participants with an upper-arm circumference of 9.0-14.6 may be placed in the medium cuff arm. | Device: A&D UA-651 Blood Pressure Monitor<br>* Test device to be validated.<br>Device: ADC 740-N Manual Sphygmomanometer<br>* Reference device. Meets or exceeds ANSI/AAMI/ISO 81060-1 as required by ISO/ESH/AAMI standards.<br>|
| Experimental: Lage Cuff<br>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. | Device: A&D UA-651 Blood Pressure Monitor<br>* Test device to be validated.<br>Device: ADC 740-N Manual Sphygmomanometer<br>* Reference device. Meets or exceeds ANSI/AAMI/ISO 81060-1 as required by ISO/ESH/AAMI standards.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure Triplet | A valid set of 3 measurements (reference-test-reference) will be considered one outcome measurement for validation. | Immediate |