Clinical trials for children's accuracy studies using an automatic blood pressure gauge with a 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

KCT0007674

Enrollment

Registered

2022-09-02

Start date

2022-08-16

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 - children between the ages of 3 and 12 - a person who puts a blood pressure gauge cuff close to the upper arm - a person with normal heart palpitations

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
Stethoscope's blood pressure of resting condition	—

Countries

Korea, Republic of

Contacts

Public ContactLee Jusung

Korea University Anam Hospital

drsuccess@naver.com+82-2-920-5114

Outcome results