Clinical trial NCT04506333: Validation of A&D UA-651 in Children
Official title: Validation of the A&D UA-651 Oscillometric Blood Pressure Monitor in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Pressure
Lead sponsor: University of Louisiana Monroe
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

Brief summary: This study will determine if the A\&D UA-651 blood pressure monitor is valid in children.


Eligibility criteria: 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.

Primary outcomes:
measure: Blood Pressure Triplet
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Monroe
country: United States
facility: University of Louisiana Monroe College of Pharmacy
state: Louisiana
Study officials:
affiliation: University of Louisiana Monroe
name: Bryan J Donald, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.