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Assessment of the accuracy of a Blood Pressure Measuring Device with a digital display-column, NISSEI DM 3000, according to an adaptation of the "European Society of Hypertension International Protocol Revision 2010 for the Validation of Blood Pressure Measuring Devices in Adults".
According to the "European Society of Hypertension International Protocol Revision 2010 for the Validation of Blood Pressure Measuring Devices in Adults", 33 patients have their blood pressure measured by two observers using parallel connected mercury sphygmomanometers, blinded from each other's result, and then by the supervisor using the tested device, NISSEI DM 3000. The measurements using the mercury sphygmomanometers are repeated 5 times and in between them, 4 measurements using the tested device take place. If the results of the comparison of these measurements according to the analysis required by the protocol, meet the required criteria, the device is regarded as "Pass", otherwise as "Fail".
In this study, instead of consecutive, simultaneous measurements of the two mercury sphygmomanometers and tha tested device will be taking place. This will be so to exclude any inaccuracy due to blood pressure variability and because the tested device has a controllable deflation rate and allows simultaneous measurements with the mercury sphygmomanometers. In addition, the investigators will be performing 6 set of measurements instead of 4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Other | All eligible patients in the study consist a single group and the same intervention is assigned to all of them. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Pressure Measurement | Other | All patients have their blood pressure measured simultaneously by two observers using parallel connected mercury sphygmomanometers and by a supervisor using the tested device, NISSEI DM 3000. Six sets of measurements are performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure Measured by Tested Device. | Mean Systolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis. | 3 months |
| Systolic Blood Pressure Measured With Mercury Sphygmomanometer. | Mean Systolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis. | 3 months |
| Diastolic Blood Pressure Measured by Tested Device. | Mean Diastolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis. | 3 months |
| Diastolic Blood Pressure Measured With Mercury Sphygmomanometer. | Mean Diastolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George S Stergiou, MD | Hypertension Center, Third Depertment of Medicine, University of Athens, Greece | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hypertension Center, Third Department of Medicine, University of Athens, Greece | Athens | Greece |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device |
| 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 | Systolic Blood Pressure Measured by Tested Device. | Mean Systolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis. | According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements. | Posted | Mean | Standard Deviation | mmHg | 3 months |
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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 | All Patients | All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George S Stergiou, MD | Hypertension Center, Third University Department of Medicine, University of Athens | +30 210 7763117 | gstergi@med.uoa.gr |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
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| Participants |
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| Primary | Systolic Blood Pressure Measured With Mercury Sphygmomanometer. | Mean Systolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis. | According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements. | Posted | Mean | Standard Deviation | mmHg | 3 months |
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| Primary | Diastolic Blood Pressure Measured by Tested Device. | Mean Diastolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis. | According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements. | Posted | Mean | Standard Deviation | mmHg | 3 months |
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| Primary | Diastolic Blood Pressure Measured With Mercury Sphygmomanometer. | Mean Diastolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis. | According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements. | Posted | Mean | Standard Deviation | mmHg | 3 months |
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