Validation of A&D UA-651 in Children

Blood Pressure Clinical Trial

Official title:

Validation of the A&D UA-651 Oscillometric Blood Pressure Monitor in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04506333
• Other study ID #: 1017
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2020
• Est. completion date: December 2020

Study information

• Verified date: August 2020
• Source: University of Louisiana Monroe
• Contact: Bryan J Donald, PharmD
• Phone: 318-342-1903
• Email: donald[@]ulm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• A&D UA-651 Blood Pressure Monitor
Test device to be validated.
• ADC 740-N Manual Sphygmomanometer
Reference device. Meets or exceeds ANSI/AAMI/ISO 81060-1 as required by ISO/ESH/AAMI standards.

Locations

Country	Name	City	State
United States	University of Louisiana Monroe College of Pharmacy	Monroe	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisiana Monroe

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure Triplet	A valid set of 3 measurements (reference-test-reference) will be considered one outcome measurement for validation.	Immediate