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Completed

NCT Number: NCT01120990

Hybrid Blood Pressure Monitor Validation

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".

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Athens, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood pressure measurement

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.

Primary outcomes

  1. Systolic Blood Pressure Measured by Tested Device.

    Time frame: 3 months

    Mean Systolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis.

  2. Systolic Blood Pressure Measured With Mercury Sphygmomanometer.

    Time frame: 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.

  3. Diastolic Blood Pressure Measured by Tested Device.

    Time frame: 3 months

    Mean Diastolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis.

  4. Diastolic Blood Pressure Measured With Mercury Sphygmomanometer.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Athens

Other

Registry information

Official study 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

Acronym: NISSEI

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 11, 2010
Registry last updated
Apr 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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