Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO

Blood Pressure Clinical Trial

Official title:

Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01359748
• Other study ID #: K8-BP-31032011
• Status: Completed
• Phase: N/A
• First received: May 16, 2011
• Last updated: July 22, 2014
• Start date: March 2011
• Est. completion date: March 2011

Study information

• Verified date: July 2014
• Source: Aguiflai Iberica, S.L.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 83 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• Reference sphygmomanometer
* USED Audible Korotkoff (K5)for Auscultatory sphygmomanometer.
• Sphygmomanometer under test
Electronic Oscillometric method.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aguiflai Iberica, S.L.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Five minutes	No
Primary	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.	30 seconds	No