Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO

Aguiflai Iberica, S.L.89 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Blood Pressure

Interventions

Reference sphygmomanometerDEVICE

\* USED Audible Korotkoff (K5)for Auscultatory sphygmomanometer.

Sphygmomanometer under testDEVICE

Electronic Oscillometric method.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 83 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

BP Measurements Using the Reference Auscultatory Sphygmomanometer

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.

Time frame: Five minutes

BP Measurement Using Multifunction KEITO

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.

Time frame: 30 seconds

Data from ClinicalTrials.gov

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