Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO

Aguiflai Iberica

Status: Completed

Conditions: Blood Pressure

Treatments: Device: Reference sphygmomanometer; Device: Sphygmomanometer under test

Study type: Interventional

Funder types: Industry

Identifiers

NCT01359748

K8-BP-31032011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 83 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

89 participants in 4 patient groups

Wrist Size <= 14.25 Cm

Other group

Description:

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

Treatment:

Device: Sphygmomanometer under test

Device: Reference sphygmomanometer

Wrist Size >=14.26 <16.50 Cm

Other group

Description:

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

Treatment:

Device: Sphygmomanometer under test

Device: Reference sphygmomanometer

Wrist size >=16.5 <17.75 Cm

Other group

Description:

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

Treatment:

Device: Sphygmomanometer under test

Device: Reference sphygmomanometer

Wrist Size >=17.75 Cm

Other group

Description:

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

Treatment:

Device: Sphygmomanometer under test

Device: Reference sphygmomanometer