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This study will determine if the A&D UA-651 blood pressure monitor is valid in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Small Cuff | Experimental | Participants with an upper-arm circumference of 6.3-9.4" may be placed in the small cuff arm. |
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| Medium Cuff | Experimental | Participants with an upper-arm circumference of 9.0-14.6" may be placed in the medium cuff arm. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A&D UA-651 Blood Pressure Monitor | Device | Test device to be validated. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Sequential Selection Criteria:
Participants will be selected sequentially during study events. Per ISO/ESH/AAMI standards, participants must meet the following characteristics:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bryan J Donald, PharmD | Contact | 318-342-1903 | donald@ulm.edu | |
| Jessica Brady, PharmD | Contact | 318-342-1697 | brady@ulm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bryan J Donald, PharmD | University of Louisiana Monroe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisiana Monroe College of Pharmacy | Monroe | Louisiana | 71201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30702492 | Background | 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. |
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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.
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Investigators and assessors will need to know which device is associated with each measurement to perform analysis as specified in ISO/ESH/AAMI standards, but observers taking manual reference blood pressure measurements will be blinded as to each other's measurements.
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| ADC 740-N Manual Sphygmomanometer | Device | Reference device. Meets or exceeds ANSI/AAMI/ISO 81060-1 as required by ISO/ESH/AAMI standards. |
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