Hybrid Blood Pressure Monitor Validation

Essential Hypertension Clinical Trial

— NISSEI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120990
• Other study ID #: Hybrid BP Monitor Validation
• Status: Completed
• Phase: Phase 4
• First received: May 6, 2010
• Last updated: April 14, 2012
• Start date: April 2010
• Est. completion date: July 2010

Study information

• Verified date: April 2012
• Source: University of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

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.

Locations

Country	Name	City	State
Greece	Hypertension Center, Third Department of Medicine, University of Athens, Greece	Athens

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No