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Completed

NCT Number: NCT03382691

Accuracy of a Blood Pressure Measuring Mobile Device in Volunteers

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.

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Key information

Conditions

Blood Pressure

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyenggi DO, 463707, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

blood pressure check

Device

Check blood pressure using new device and conventional device alternatively. Compare blood pressure measured with new device and conventional device.

Primary outcomes

  1. mean difference of systolic blood pressure

    Time frame: 1 day at visit 2

    mean difference of blood pressure between new and control device

  2. mean difference of diastolic blood pressure

    Time frame: 1 day at visit 2

    mean difference of diastolic blood pressure between new and control device

  3. standard deviation of the difference of systolic blood pressure

    Time frame: 1 day at visit 2

    standard deviation of the difference of systolic blood pressure between new and control device

  4. standard deviation of the difference of diastolic blood pressure

    Time frame: 1 day at visit 2

    standard deviation of the difference of diastolic blood pressure between new and control device

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Seoul National University Bundang Hospital

Registry information

Official study title

M- HEALTHCARE Confirmatory Clinical Trials Used for Measurement of the ABP for the Accuracy and Safety Assessment of the Module Measuring Blood Pressure

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 26, 2017
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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