Hybrid Blood Pressure Monitor Validation (NISSEI)

National and Kapodistrian University of Athens

Status and phase: Completed; Phase 4

Conditions: Essential Hypertension

Treatments: Other: Blood Pressure Measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT01120990

Hybrid BP Monitor Validation

Details and patient eligibility

About

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".

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

All patients

Other group

Description:

All eligible patients in the study consist a single group and the same intervention is assigned to all of them.

Treatment:

Other: Blood Pressure Measurement