Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Device: Reference sphygmomanometer; Device: Sphygmomanometer under test

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 Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Wrist Size <= 14.25 Cm; Blood pressure measured using the reference sphygmomanometer.; Blood pressure measured using the Sphygmomanometer under test.	Device: Reference sphygmomanometer; * USED Audible Korotkoff (K5)for Auscultatory sphygmomanometer.; Other Names: *Ref Auscult. sphygm.: RIESTER MINIMUS S/N 20534567; Device: Sphygmomanometer under test; Electronic Oscillometric method.; Other Names: * Multifunction KEITO K7 S/N 1941.
Other: Wrist Size >=14.26 <16.50 Cm; Blood pressure measured using the reference sphygmomanometer.; Blood pressure measured using the Sphygmomanometer under test.	Device: Reference sphygmomanometer; * USED Audible Korotkoff (K5)for Auscultatory sphygmomanometer.; Other Names: *Ref Auscult. sphygm.: RIESTER MINIMUS S/N 20534567; Device: Sphygmomanometer under test; Electronic Oscillometric method.; Other Names: * Multifunction KEITO K7 S/N 1941.
Other: Wrist size >=16.5 <17.75 Cm; Blood pressure measured using the reference sphygmomanometer.; Blood pressure measured using the Sphygmomanometer under test.	Device: Reference sphygmomanometer; * USED Audible Korotkoff (K5)for Auscultatory sphygmomanometer.; Other Names: *Ref Auscult. sphygm.: RIESTER MINIMUS S/N 20534567; Device: Sphygmomanometer under test; Electronic Oscillometric method.; Other Names: * Multifunction KEITO K7 S/N 1941.
Other: Wrist Size >=17.75 Cm; Blood pressure measured using the reference sphygmomanometer.; Blood pressure measured using the Sphygmomanometer under test.	Device: Reference sphygmomanometer; * USED Audible Korotkoff (K5)for Auscultatory sphygmomanometer.; Other Names: *Ref Auscult. sphygm.: RIESTER MINIMUS S/N 20534567; Device: Sphygmomanometer under test; Electronic Oscillometric method.; Other Names: * Multifunction KEITO K7 S/N 1941.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Aguiflai Iberica, S.L.
• Investigators: Study Director: Angel P Ferre, Engineer; Study Chair: Francisco B Contreras, Technician

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: May 16, 2011
• First Submitted That Met QC Criteria: May 24, 2011
• First Posted (Estimate): May 25, 2011

Study Record Updates

• Last Update Posted (Estimate): July 29, 2014
• Last Update Submitted That Met QC Criteria: July 22, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Non Invasive Blood Pressure measurement study.
• Other Study ID Numbers: K8-BP-31032011