A clinical trial for the study of the accuracy of the general public using an automatic blood pressure gauge with stethoscope according to the protocol presented by the International Organization for Standardization

Clinical trial for automatic blood pressure meter accuracy study applied to children using stethoscope according to AAMI/ESH/ISO Universal Standard (ISO 81060-2:28)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007753

Enrollment

100

Registered

2022-09-29

Start date

2022-08-29

Completion date

Unknown

Last updated

2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : The protocol applied to the auscultation-applied automatic blood pressure monitor used in this study is ISO 81060-2:2018 Non-invasivesphygmomanometers-Part 2: Clinical investigation o

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects presented in ISO 81060-2:2018 Integration Protocol - Adult men and women aged between 20 and 80 (at least 30 persons by gender, respectively) - A person who has access to a blood pressure cuff on the upper arm - a person with a normal heart rhythm - a ruler with an arm circumference of 22–42 cm

Exclusion criteria

Exclusion criteria: - A person who does not have normal cardiac binding nodes, such as arrhythmia, peripheral artery disease including carotid artery stenosis, etc. - A person who is unable to hear a sound signal and whose blood pressure is not recognized by the sound method - a person of psychological importance

Design outcomes

Primary

Measure	Time frame
Test device's blood pressure of resting condition	—

Secondary

Measure	Time frame
Test device's blood pressure of resting condition	—

Countries

Korea, Republic of

Contacts

Public ContactChoi Jong-il

Korea University Anam Hospital

stabler92@gmail.com+82-2-920-5114

Outcome results