Phase 4 N=51 Diagnostic

Hybrid Blood Pressure Monitor Validation

Essential Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01120990 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2012

Primary outcome: Primary: Systolic Blood Pressure Measured by Tested Device. — 144.11 mmHg

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Blood Pressure Measurement (Other)
Age: Adult, Older Adult · 25+ yrs
Sex: All
Sponsor: University of Athens
Primary completion: Jun 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Systolic Blood Pressure Measured by Tested Device.	144.11	—
PRIMARY Systolic Blood Pressure Measured With Mercury Sphygmomanometer.	143.92	—
PRIMARY Diastolic Blood Pressure Measured by Tested Device.	90.72	—
PRIMARY Diastolic Blood Pressure Measured With Mercury Sphygmomanometer.	90.51	—

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".

Eligibility 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01120990). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.