Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO

Not Applicable

Completed

• Conditions: Blood Pressure
• Interventions: Device: Reference sphygmomanometer; Device: Sphygmomanometer under test

• Registration Number: NCT01359748
• Lead Sponsor: Aguiflai Iberica, S.L.

Brief 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.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2011-05-16
• Study First Submitted QC: 2011-05-24
• Study First Posted: 2011-05-25
• Results First Submitted: 2011-06-02
• Results First Submitted QC: 2013-09-04
• Results First Posted: 2013-11-07
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-22
• Last Update Posted: 2014-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Wrist Size >=14.26 <16.50 Cm	Reference sphygmomanometer	* Blood pressure measured using the reference sphygmomanometer. * Blood pressure measured using the Sphygmomanometer under test.
Wrist Size <= 14.25 Cm	Sphygmomanometer under test	* Blood pressure measured using the reference sphygmomanometer. * Blood pressure measured using the Sphygmomanometer under test.
Wrist Size <= 14.25 Cm	Reference sphygmomanometer	* Blood pressure measured using the reference sphygmomanometer. * Blood pressure measured using the Sphygmomanometer under test.
Wrist size >=16.5 <17.75 Cm	Sphygmomanometer under test	* Blood pressure measured using the reference sphygmomanometer. * Blood pressure measured using the Sphygmomanometer under test.
Wrist Size >=17.75 Cm	Sphygmomanometer under test	* Blood pressure measured using the reference sphygmomanometer. * Blood pressure measured using the Sphygmomanometer under test.
Wrist Size >=14.26 <16.50 Cm	Sphygmomanometer under test	* Blood pressure measured using the reference sphygmomanometer. * Blood pressure measured using the Sphygmomanometer under test.
Wrist size >=16.5 <17.75 Cm	Reference sphygmomanometer	* Blood pressure measured using the reference sphygmomanometer. * Blood pressure measured using the Sphygmomanometer under test.
Wrist Size >=17.75 Cm	Reference sphygmomanometer	* Blood pressure measured using the reference sphygmomanometer. * Blood pressure measured using the Sphygmomanometer under test.

Primary Outcome Measures

Name	Time	Method
BP Measurements Using the Reference Auscultatory Sphygmomanometer	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	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.