Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO

NCT01359748 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2014-07-29

Study results available
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Summary

The purpose of this trial is to determine the accuracy of the Blood Pressure (BP) measurement of multifunction KEITO devices under test requirements of the Standard American National Standards Institute(ANSI)/Association for the Advancement of Medical Instrumentation(AAMI)/International Organization for Standardization (ISO): ANSI/AAMI/ISO 81060-2:2009.

Conditions

  • Blood Pressure

Interventions

DEVICE

Reference sphygmomanometer

\* USED Audible Korotkoff (K5)for Auscultatory sphygmomanometer.

DEVICE

Sphygmomanometer under test

Electronic Oscillometric method.

Sponsors & Collaborators

  • Aguiflai Iberica, S.L.

    lead INDUSTRY

Principal Investigators

  • Angel P Ferre, Engineer

  • Francisco B Contreras, Technician

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
83 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-03-31
Completion
2011-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01359748 on ClinicalTrials.gov