Hybrid Blood Pressure Monitor Validation

Phase 4

Completed

• Conditions: Essential Hypertension
• Interventions: Other: Blood Pressure Measurement

• Registration Number: NCT01120990
• Lead Sponsor: University of Athens

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-06
• Study First Submitted QC: 2010-05-10
• Study First Posted: 2010-05-11
• Primary Completion: 2010-06
• Study Completion: 2010-07
• Results First Submitted: 2010-12-03
• Results First Submitted QC: 2012-02-04
• Results First Posted: 2012-03-07
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-14
• Last Update Posted: 2012-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	Blood Pressure Measurement	All eligible patients in the study consist a single group and the same intervention is assigned to all of them.

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Hypertension Center, Third Department of Medicine, University of Athens, Greece; 🇬🇷 Athens, Greece