Validation of A&D UA-651 in Children

Not Applicable

• Conditions: Blood Pressure
• Interventions: Device: A&D UA-651 Blood Pressure Monitor; Device: ADC 740-N Manual Sphygmomanometer

• Registration Number: NCT04506333
• Lead Sponsor: University of Louisiana Monroe

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study Start: 2020-08
• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-06
• Last Update Submitted: 2020-08-06
• Study First Posted: 2020-08-10
• Last Update Posted: 2020-08-10
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Small Cuff	ADC 740-N Manual Sphygmomanometer	Participants with an upper-arm circumference of 6.3-9.4" may be placed in the small cuff arm.
Medium Cuff	A&D UA-651 Blood Pressure Monitor	Participants with an upper-arm circumference of 9.0-14.6" may be placed in the medium cuff arm.
Small Cuff	A&D UA-651 Blood Pressure Monitor	Participants with an upper-arm circumference of 6.3-9.4" may be placed in the small cuff arm.
Lage Cuff	A&D UA-651 Blood Pressure Monitor	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.
Lage Cuff	ADC 740-N Manual Sphygmomanometer	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.
Medium Cuff	ADC 740-N Manual Sphygmomanometer	Participants with an upper-arm circumference of 9.0-14.6" may be placed in the medium cuff arm.

Primary Outcome Measures

Name	Time	Method
Blood Pressure Triplet	Immediate	A valid set of 3 measurements (reference-test-reference) will be considered one outcome measurement for validation.

Trial Locations

Locations (1)

University of Louisiana Monroe College of Pharmacy; 🇺🇸 Monroe, Louisiana, United States