Clinical trial NCT01120990: Hybrid Blood Pressure Monitor Validation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Essential Hypertension
Keywords: Blood pressure measuring devices
Essential Hypertension
Automated blood pressure measurement
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2010-05-11
Enrollment: 51
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Systolic Blood Pressure Measured by Tested Device.
timeFrame: 3 months
measure: Systolic Blood Pressure Measured With Mercury Sphygmomanometer.
timeFrame: 3 months
measure: Diastolic Blood Pressure Measured by Tested Device.
timeFrame: 3 months
measure: Diastolic Blood Pressure Measured With Mercury Sphygmomanometer.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hypertension Center, Third Department of Medicine, University of Athens, Greece
Study officials:
affiliation: Hypertension Center, Third Depertment of Medicine, University of Athens, Greece
name: George S Stergiou, MD
role: STUDY_CHAIR
References: