Essential Hypertension
Conditions
Keywords
Blood pressure measuring devices, Essential Hypertension, Automated blood pressure measurement
Brief summary
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.
Detailed description
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.
Interventions
OTHERBlood Pressure Measurement
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.
Sponsors
University of Athens
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Above 25 years of age * Sinus rhythm * Informed consent
Exclusion criteria
* Sustained arrhythmia * Pregnancy * Poor quality Korotkoff sounds * Unavailable cuff size * Completed blood pressure range (according to protocol)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic Blood Pressure Measured With Mercury Sphygmomanometer. | 3 months | Mean Diastolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis. |
| Systolic Blood Pressure Measured by Tested Device. | 3 months | Mean Systolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis. |
| Systolic Blood Pressure Measured With Mercury Sphygmomanometer. | 3 months | Mean Systolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis. |
| Diastolic Blood Pressure Measured by Tested Device. | 3 months | Mean Diastolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis. |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants |
| Age Continuous | 50.4 years STANDARD_DEVIATION 16.3 |
| Region of Enrollment Greece | 51 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
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.
Time frame: 3 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Diastolic Blood Pressure Measured by Tested Device. | 90.72 mmHg | Standard Deviation 20.02 |
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.
Time frame: 3 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Diastolic Blood Pressure Measured With Mercury Sphygmomanometer. | 90.51 mmHg | Standard Deviation 19.87 |
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.
Time frame: 3 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Systolic Blood Pressure Measured by Tested Device. | 144.11 mmHg | Standard Deviation 27.72 |
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.
Time frame: 3 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Systolic Blood Pressure Measured With Mercury Sphygmomanometer. | 143.92 mmHg | Standard Deviation 27.18 |