Validation of A&D UA-651 in Children

University of Louisiana Monroe

Status: Unknown

Conditions: Blood Pressure

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04506333

1017

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 3 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Small Cuff

Experimental group

Description:

Participants with an upper-arm circumference of 6.3-9.4" may be placed in the small cuff arm.

Treatment:

Device: ADC 740-N Manual Sphygmomanometer

Device: A&D UA-651 Blood Pressure Monitor

Medium Cuff

Experimental group

Description:

Participants with an upper-arm circumference of 9.0-14.6" may be placed in the medium cuff arm.

Treatment:

Device: ADC 740-N Manual Sphygmomanometer

Device: A&D UA-651 Blood Pressure Monitor

Lage Cuff

Experimental group

Description:

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.

Treatment:

Device: ADC 740-N Manual Sphygmomanometer

Device: A&D UA-651 Blood Pressure Monitor