Validation of A&D UA-651 in Children

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.

Study Overview

• Status: Unknown
• Conditions: Blood Pressure
• Intervention / Treatment: Device: A&D UA-651 Blood Pressure Monitor; Device: ADC 740-N Manual Sphygmomanometer

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bryan J Donald, PharmD; Phone Number: 318-342-1903; Email: donald@ulm.edu
• Study Contact Backup: Name: Jessica Brady, PharmD; Phone Number: 318-342-1697; Email: brady@ulm.edu

Study Locations

• United States
  • Louisiana
    • Monroe, Louisiana, United States, 71201
      • University of Louisiana Monroe College of Pharmacy
      • Contact: Bryan J Donald, PharmD; Phone Number: 318-342-1903; Email: donald@ulm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Small Cuff; 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; Test device to be validated.; Device: ADC 740-N Manual Sphygmomanometer; Reference device. Meets or exceeds ANSI/AAMI/ISO 81060-1 as required by ISO/ESH/AAMI standards.
EXPERIMENTAL: Medium Cuff; 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; Test device to be validated.; Device: ADC 740-N Manual Sphygmomanometer; Reference device. Meets or exceeds ANSI/AAMI/ISO 81060-1 as required by ISO/ESH/AAMI standards.
EXPERIMENTAL: 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.	Device: A&D UA-651 Blood Pressure Monitor; Test device to be validated.; Device: ADC 740-N Manual Sphygmomanometer; Reference device. Meets or exceeds ANSI/AAMI/ISO 81060-1 as required by ISO/ESH/AAMI standards.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Louisiana Monroe
• Investigators: Principal Investigator: Bryan J Donald, PharmD, University of Louisiana Monroe

Publications and helpful links

General 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. Erratum In: J Hypertens. 2020 Mar;38(3):561.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (ACTUAL): August 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 1017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No