Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO

Study Overview
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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.

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.

Official Title
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Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO

Conditions
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Blood Pressure

Intervention / Treatment
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* Device: Reference sphygmomanometer
* Device: Sphygmomanometer under test


Participation Criteria
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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 Exclusion Criteria: Pregnant Women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 83 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non Invasive Blood Pressure measurement study.