Hybrid Blood Pressure Monitor Validation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Validation of a Hybrid Blood Pressure Monitor to Replace the Mercury Standard for Validation Studies According to Modified Criteria of the European Society of Hypertension International Protocol 2010

Conditions
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Essential Hypertension

Intervention / Treatment
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* Other: Blood Pressure Measurement


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 25 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

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All patients<br>All eligible patients in the study consist a single group and the same intervention is assigned to all of them. | Other: Blood Pressure Measurement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood pressure measuring devices, Essential Hypertension, Automated blood pressure measurement