Validation of A&D UA-651 in Children
Validation of the A&D UA-651 Oscillometric Blood Pressure Monitor in Children
1 other identifier
interventional
50
1 country
1
Brief Summary
This study will determine if the A\&D UA-651 blood pressure monitor is valid in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2020
CompletedFirst Submitted
Initial submission to the registry
August 6, 2020
CompletedFirst Posted
Study publicly available on registry
August 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedAugust 10, 2020
August 1, 2020
4 months
August 6, 2020
August 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Blood Pressure Triplet
A valid set of 3 measurements (reference-test-reference) will be considered one outcome measurement for validation.
Immediate
Study Arms (3)
Small Cuff
EXPERIMENTALParticipants with an upper-arm circumference of 6.3-9.4" may be placed in the small cuff arm.
Medium Cuff
EXPERIMENTALParticipants with an upper-arm circumference of 9.0-14.6" may be placed in the medium cuff arm.
Lage Cuff
EXPERIMENTALParticipants 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.
Interventions
Reference device. Meets or exceeds ANSI/AAMI/ISO 81060-1 as required by ISO/ESH/AAMI standards.
Eligibility Criteria
You may qualify if:
- Parent permission
- Assent for participants aged 7-12
- Additional sequential selection criteria (described below)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Louisiana Monroe College of Pharmacy
Monroe, Louisiana, 71201, United States
Related Publications (1)
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.
PMID: 30702492BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Bryan J Donald, PharmD
University of Louisiana Monroe
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- 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.
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2020
First Posted
August 10, 2020
Study Start
August 1, 2020
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
August 10, 2020
Record last verified: 2020-08