Accuracy of a Blood Pressure Measuring Mobile Device in Volunteers

Not Applicable

Completed

• Conditions: Blood Pressure
• Interventions: Device: blood pressure check

• Registration Number: NCT03382691
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-10
• Study First Submitted: 2017-10-29
• Study First Submitted QC: 2017-12-22
• Last Update Submitted: 2017-12-22
• Study First Posted: 2017-12-26
• Last Update Posted: 2017-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EXPERIMENTAL	blood pressure check	Blood pressure check using mobile device and control device

Primary Outcome Measures

Name	Time	Method
mean difference of systolic blood pressure	1 day at visit 2	mean difference of blood pressure between new and control device
mean difference of diastolic blood pressure	1 day at visit 2	mean difference of diastolic blood pressure between new and control device
standard deviation of the difference of systolic blood pressure	1 day at visit 2	standard deviation of the difference of systolic blood pressure between new and control device
standard deviation of the difference of diastolic blood pressure	1 day at visit 2	standard deviation of the difference of diastolic blood pressure between new and control device

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam Si, Gyenggi DO, Korea, Republic of