Hybrid Blood Pressure Monitor Validation

NCT01120990 | Completed Phase 4 Results

• 1 other identifier: Hybrid BP Monitor Validation
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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".

Conditions

Essential Hypertension

Keywords

Blood pressure measuring devices; Essential Hypertension; Automated blood pressure measurement

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

All patients

OTHER

All eligible patients in the study consist a single group and the same intervention is assigned to all of them.

Other: Blood Pressure Measurement

Interventions

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.

All patients

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above 25 years of age
• Sinus rhythm
• Informed consent

You may not qualify if:

• Sustained arrhythmia
• Pregnancy
• Poor quality Korotkoff sounds
• Unavailable cuff size
• Completed blood pressure range (according to protocol)

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

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

Athens, Greece

Location

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: George S Stergiou, MD
• Organization: Hypertension Center, Third University Department of Medicine, University of Athens

gstergi@med.uoa.gr

+30 210 7763117

Study Officials

• George S Stergiou, MD

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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Hypertension

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 11, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2010
• Last Updated: April 18, 2012
• Results First Posted: March 7, 2012

Record last verified: 2012-04

Locations

GR (1)