Hybrid Blood Pressure Monitor Validation

NCT ID: NCT01120990

Last Updated: 2012-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2010-07-31

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.

Conditions

Essential Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

All patients

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

Group Type: OTHER

Blood Pressure Measurement

Intervention Type: 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.

Interventions

Blood 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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Athens

OTHER

Sponsor Role: lead

Responsible Party

George S. Stergiou

Associate Professor of Medicine and Hypertension

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George S Stergiou, MD

Role: STUDY_CHAIR

Hypertension Center, Third Depertment of Medicine, University of Athens, Greece

Locations

Hypertension Center, Third Department of Medicine, University of Athens, Greece

Athens, , Greece

Countries

Greece

Other Identifiers

Hybrid BP Monitor Validation

Identifier Type: -

Identifier Source: org_study_id