Blood Pressure
Conditions
Keywords
Non Invasive Blood Pressure measurement study.
Brief 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.
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.
Interventions
DEVICEReference sphygmomanometer
\* USED Audible Korotkoff (K5)for Auscultatory sphygmomanometer.
DEVICESphygmomanometer under test
Electronic Oscillometric method.
Sponsors
Aguiflai Iberica, S.L.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 83 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BP Measurements Using the Reference Auscultatory Sphygmomanometer | Five minutes | 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. |
| BP Measurement Using Multifunction KEITO | 30 seconds | 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. |
Participant flow
Recruitment details
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 \[5.1.4\]
Participants by arm
| Arm | Count |
|---|---|
| Wrist Size <=14.25Cm Subjects, males or females, with wrist size specified. | 20 |
| Wrist Size<=16.40 Cm Subjects, males or females, with wrist size specified. | 48 |
| Wrist Size >=16.5 Cm Subjects, males or females, with wrist size specified. | 10 |
| Wrist Size >=17.75 Subjects, males or females, with wrist size specified. | 11 |
| Total | 89 |
Baseline characteristics
| Characteristic | Wrist Size <=14.25Cm | Wrist Size<=16.40 Cm | Wrist Size >=16.5 Cm | Wrist Size >=17.75 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 5 Participants | 5 Participants | 1 Participants | 1 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 43 Participants | 9 Participants | 10 Participants | 76 Participants |
| Sex: Female, Male Female | 12 Participants | 26 Participants | 1 Participants | 2 Participants | 41 Participants |
| Sex: Female, Male Male | 8 Participants | 22 Participants | 9 Participants | 9 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 48 | 0 / 10 | 0 / 11 |
| serious Total, serious adverse events | 0 / 20 | 0 / 48 | 0 / 10 | 0 / 11 |
Outcome results
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.
Time frame: Five minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects | BP Measurements Using the Reference Auscultatory Sphygmomanometer | Systolic Maximum (mmHg) | 186 mmHg | Standard Deviation 3.1 |
| Subjects | BP Measurements Using the Reference Auscultatory Sphygmomanometer | Diastolic Maximum (mmHg) | 107 mmHg | Standard Deviation 3 |
| Subjects | BP Measurements Using the Reference Auscultatory Sphygmomanometer | Systolic Minimum (mmHg) | 93 mmHg | Standard Deviation 3.1 |
| Subjects | BP Measurements Using the Reference Auscultatory Sphygmomanometer | Diastolic Minimum (mmHg) | 53 mmHg | Standard Deviation 3 |
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.
Time frame: 30 seconds
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects | BP Measurement Using Multifunction KEITO | Systolic Maximum | 174 mmHg | Standard Deviation 5.2 |
| Subjects | BP Measurement Using Multifunction KEITO | Diastolic Maximum | 98 mmHg | Standard Deviation 4.5 |
| Subjects | BP Measurement Using Multifunction KEITO | Systolic Minimum | 94 mmHg | Standard Deviation 5.2 |
| Subjects | BP Measurement Using Multifunction KEITO | Diastolic Minimum | 55 mmHg | Standard Deviation 4.5 |