Hybrid Blood Pressure Monitor Validation (NISSEI)

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

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".

Study Overview

• Status: Completed
• Conditions: Essential Hypertension
• Intervention / Treatment: Other: Blood Pressure Measurement

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: All patients; All eligible patients in the study consist a single group and the same intervention is assigned to all of them.	Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Athens

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): June 1, 2010
• Study Completion (ACTUAL): July 1, 2010

Study Registration Dates

• First Submitted: May 6, 2010
• First Submitted That Met QC Criteria: May 10, 2010
• First Posted (ESTIMATE): May 11, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): April 18, 2012
• Last Update Submitted That Met QC Criteria: April 14, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Essential Hypertension; Blood pressure measuring devices; Automated blood pressure measurement
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: Hybrid BP Monitor Validation