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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wrist Size <= 14.25 Cm | Other |
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| Wrist Size >=14.26 <16.50 Cm | Other |
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| Wrist size >=16.5 <17.75 Cm | Other |
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| Wrist Size >=17.75 Cm | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reference sphygmomanometer | Device | * USED Audible Korotkoff (K5)for Auscultatory sphygmomanometer. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angel P Ferre, Engineer | Study Director | |
| Francisco B Contreras, Technician | Study Chair |
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To recruit the volunteers, we have complied with the limb size distribution required on Standard Association for the American National Standards Institute(ANSI)/Association for the Advancement of Medical Instrumentation (AAMI)/International Organization for Standardization (ISO): ANSI/AAMI/ISO 81060-2:2009 [5.1.4]
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects With Wrist Size >=14.26Cm | Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference. The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm. |
| FG001 | Subjects With Wrist Size <=14.25Cm | Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference. The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm. |
| FG002 | Subjects With Wrist Size >=16.50Cm | Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference. The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm. |
| FG003 | Subjects With Wrist Size >=17.75Cm | Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference. The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Wrist Size <=14.25Cm | Subjects, males or females, with wrist size specified. |
| BG001 | Wrist Size<=16.40 Cm | Subjects, males or females, with wrist size specified. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | mmHg | Five minutes |
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No adverse events were collected.
No adverse events were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Wrist Size <=14.25 Cm | Subjects with wrist size equal or less than 14.25 Cm |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angel Pons Ferré | Aguiflai Iberica, SL | +34 93 7540370 | calidad@keito.com |
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| Sphygmomanometer under test | Device | Electronic Oscillometric method. |
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| BG002 | Wrist Size >=16.5 Cm | Subjects, males or females, with wrist size specified. |
| BG003 | Wrist Size >=17.75 | Subjects, males or females, with wrist size specified. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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. | Posted | Mean | Standard Deviation | mmHg | 30 seconds |
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| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Wrist Size <=16.4Cm | Subjects with wrist size equal or less than 16.40 Cm | 0 | 48 | 0 | 48 |
| EG002 | Wrist Size >=16.5 Cm | Subjects with wrist size equal or higher than 16.5 Cm | 0 | 10 | 0 | 10 |
| EG003 | Wrist Size >=17.75 Cm | Subjects with wrist size equal or higher than 17.75 Cm | 0 | 11 | 0 | 11 |
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| Diastolic Minimum |
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