Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-03-31

Brief Summary

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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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Detailed Description

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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

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Blood Pressure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Wrist Size <= 14.25 Cm

* Blood pressure measured using the reference sphygmomanometer.
* Blood pressure measured using the Sphygmomanometer under test.

Group Type OTHER

Reference sphygmomanometer

Intervention Type DEVICE

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

Sphygmomanometer under test

Intervention Type DEVICE

Electronic Oscillometric method.

Wrist Size >=14.26 <16.50 Cm

* Blood pressure measured using the reference sphygmomanometer.
* Blood pressure measured using the Sphygmomanometer under test.

Group Type OTHER

Reference sphygmomanometer

Intervention Type DEVICE

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

Sphygmomanometer under test

Intervention Type DEVICE

Electronic Oscillometric method.

Wrist size >=16.5 <17.75 Cm

* Blood pressure measured using the reference sphygmomanometer.
* Blood pressure measured using the Sphygmomanometer under test.

Group Type OTHER

Reference sphygmomanometer

Intervention Type DEVICE

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

Sphygmomanometer under test

Intervention Type DEVICE

Electronic Oscillometric method.

Wrist Size >=17.75 Cm

* Blood pressure measured using the reference sphygmomanometer.
* Blood pressure measured using the Sphygmomanometer under test.

Group Type OTHER

Reference sphygmomanometer

Intervention Type DEVICE

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

Sphygmomanometer under test

Intervention Type DEVICE

Electronic Oscillometric method.

Interventions

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Reference sphygmomanometer

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

Intervention Type DEVICE

Sphygmomanometer under test

Electronic Oscillometric method.

Intervention Type DEVICE

Other Intervention Names

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*Ref Auscult. sphygm.: RIESTER MINIMUS S/N 20534567 * Multifunction KEITO K7 S/N 1941.

Eligibility Criteria

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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