Phase 4
Completed N=51
Hybrid Blood Pressure Monitor Validation
Source: ClinicalTrials.gov NCT01120990 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcomePrimary: Systolic Blood Pressure Measured by Tested Device. — 144.11 mmHg
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".
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 | — |
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)
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. Informational only — not medical advice.