Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO
NCT01359748 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89
Last updated 2014-07-29
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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