Blood Pressure
Conditions
Brief summary
This study will determine if the A&D UA-651 blood pressure monitor is valid in children.
Interventions
DEVICEA&D UA-651 Blood Pressure Monitor
Test device to be validated.
DEVICEADC 740-N Manual Sphygmomanometer
Reference device. Meets or exceeds ANSI/AAMI/ISO 81060-1 as required by ISO/ESH/AAMI standards.
Sponsors
University of Louisiana Monroe
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Masking description
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.
Intervention model description
The ISO/ESH/AAMI standards for validating blood pressure measurement devices will be used. In this model, participants' blood pressures are taken alternating between the test device and a reference device.
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure Triplet | Immediate | A valid set of 3 measurements (reference-test-reference) will be considered one outcome measurement for validation. |
Countries
United States
Contacts
Primary ContactBryan J Donald, PharmD
Backup ContactJessica Brady, PharmD
Outcome results
None listed