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Hybrid Blood Pressure Monitor Validation (NISSEI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
George S. Stergiou, University of Athens
ClinicalTrials.gov Identifier:
NCT01120990
First received: May 6, 2010
Last updated: April 14, 2012
Last verified: April 2012
History of Changes
  Purpose

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".


Condition Intervention Phase
Essential Hypertension
 Other: Blood Pressure Measurement
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Athens:

Primary Outcome Measures:
  • Systolic Blood Pressure Measured by Tested Device. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Mean Diastolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis.


Enrollment: 51
Study Start Date: April 2010
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120990

Locations
Greece
Hypertension Center, Third Department of Medicine, University of Athens, Greece
Athens, Greece
Sponsors and Collaborators
University of Athens
Investigators
Study Chair: George S Stergiou, MD Hypertension Center, Third Depertment of Medicine, University of Athens, Greece
  More Information

No publications provided

Responsible Party: George S. Stergiou, Associate Professor of Medicine and Hypertension, University of Athens
ClinicalTrials.gov Identifier: NCT01120990     History of Changes
Other Study ID Numbers: Hybrid BP Monitor Validation
Study First Received: May 6, 2010
Results First Received: December 3, 2010
Last Updated: April 14, 2012
Health Authority: Greece: Ethics Committee

Keywords provided by University of Athens:
Blood pressure measuring devices
Essential Hypertension
Automated blood pressure measurement

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013