Status:
UNKNOWN
Validation of A&D UA-651 in Children
Lead Sponsor:
University of Louisiana Monroe
Conditions:
Blood Pressure
Eligibility:
All Genders
3-12 years
Phase:
NA
Brief Summary
This study will determine if the A\&D UA-651 blood pressure monitor is valid in children.
Eligibility Criteria
Inclusion
- Parent permission
- Assent for participants aged 7-12
- Additional sequential selection criteria (described below)
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04506333
Start Date
August 1 2020
End Date
December 1 2020
Last Update
August 10 2020
Active Locations (1)
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1
University of Louisiana Monroe College of Pharmacy
Monroe, Louisiana, United States, 71201