NCT01359748

Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Aguiflai Iberica, S.L. · Industry
• Sex: All
• Age: 18 Years – 83 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Blood Pressure

Interventions

Type	Name	Description
DEVICE	Reference sphygmomanometer	\* USED Audible Korotkoff (K5)for Auscultatory sphygmomanometer.
DEVICE	Sphygmomanometer under test	Electronic Oscillometric method.

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2011-05-25
• Last updated: 2014-07-29
• Results posted: 2013-11-07