Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO

The purpose of this trial is to determine the accuracy of the Blood Pressure (BP) measurement of multifunction KEITO devices under test requirements of the Standard American National Standards Institute(ANSI)/Association for the Advancement of Medical Instrumentation(AAMI)/International Organization for Standardization (ISO): ANSI/AAMI/ISO 81060-2:2009.

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Key information

Conditions

Blood Pressure

Age range

18 year–83 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Nowadays is important controlling our basic health parameters. Due this, the multifunction KEITO Devices was designed to offer to the general public a convenient way to do so easily in the public sites.

One of the most important parameter is the Blood Pressure (BP)measurement. To warrant their efficacity and accuracy, was essential to perform this trial to ensure that the measurements obtained meet with the requirements of the specific U.S. standard about Non-invasive sphygmomanometers.

By Validating with auscultatory reference sphygmomanometer, as defined on the ANSI/AAMI/ISO 81060-2:2009 , we have been intending to demonstrate that the multifunction KEITO devices, particularly about the Blood Pressure (BP) Measurement, have the same efficacy and accuracy as the conventional auscultatory sphygmomanometers.

To include most of the groups of Blood Pressure (BP) measurements types on this clinical trial, a great variety of BP ranges have been selected, always in accordance with the standard.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Wrist circumference: 12 to 20 Cm
At least 5% of the readings shall have Systolic BP<=100 mmHg
At least 5% of the readings shall have Systolic BP>=160 mmHg
At least 20% of the readings shall have Systolic BP>=140 mmHg
At least 5% of the readings shall have Diastolic BP<=60 mmHg
At least 5% of the readings shall have Diastolic BP>=100 mmHg
At least 20% of the readings shall have Diastolic BP>=85 mmHg

Exclusion criteria

Pregnant Women

Treatment and study plan

Reference sphygmomanometer

Device

USED Audible Korotkoff (K5)for Auscultatory sphygmomanometer.

Other names: *Ref Auscult. sphygm.: RIESTER MINIMUS S/N 20534567

Sphygmomanometer under test

Device

Electronic Oscillometric method.

Other names: * Multifunction KEITO K7 S/N 1941.

Primary outcomes

BP Measurements Using the Reference Auscultatory Sphygmomanometer

Time frame: Five minutes

The subject was measured by the two observers at the same time using the reference sphygmomanometer and double stethoscope.

The observers agree to take the K5 korotkoff sound. Each observer takes notes of their own measures.
BP Measurement Using Multifunction KEITO

Time frame: 30 seconds

Prior starting the measurement phase using Multifunction KEITO, the under test device was reset before each new measurement.

The subject has to be at rest at least 60 seconds before be measured.

Sponsors and collaborators

Lead sponsor

Aguiflai Iberica, S.L.

Industry

Registry information

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: May 25, 2011
Registry last updated: Jul 29, 2014

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.

Published trials that share one or more normalized conditions with this study.

Completed