Accuracy of a Blood Pressure Measuring Mobile Device in Volunteers

Seoul National University

Status: Completed

Conditions: Blood Pressure

Treatments: Device: blood pressure check

Study type: Interventional

Funder types: Other

Identifiers

NCT03382691

SNUBH_GO_056

Details and patient eligibility

About

The accuracy and safety of blood pressure module of new mobile device (M- HEALTHCARE device) is evaluated according to Korean FDA guidelines in 100 healthy volunteers.

Enrollment: 100 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Participants whose systolic blood pressure <=110 should be at least 10% of whole cohort
2. Participants whose systolic blood pressure >=160 should be at least 10% of whole cohort
3. Participants whose diastolic blood pressure >=100 should be at least 10% of whole cohort
4. Participants whose diastolic blood pressure <=70 should be at least 10% of whole cohort
5. Participants whose arm circumference are between 20cm and 30cm should be 25 - 50% of whole cohort
6. Participants whose arm circumference are between 30cm and 40cm should be 50 - 75% of whole cohort

Exclusion criteria

1. heart disease with abnormal rhythm
2. peripheral vascular anomaly or disease
3. inadequate to be applied blood pressure cuff (e.g. trauma on arm)
4. pregnant or lactating women

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

EXPERIMENTAL

Experimental group

Description:

Blood pressure check using mobile device and control device

Treatment:

Device: blood pressure check