N/A N=89

Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO

Blood Pressure

Bottom Line

View on ClinicalTrials.gov: NCT01359748 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2013

Primary outcome: Primary: BP Measurements Using the Reference Auscultatory Sphygmomanometer — 186; 107; 93; 53 mmHg

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Reference sphygmomanometer (Device); Sphygmomanometer under test (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Aguiflai Iberica, S.L.
Primary completion: Mar 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY BP Measurements Using the Reference Auscultatory Sphygmomanometer	186; 107; 93; 53	—
PRIMARY BP Measurement Using Multifunction KEITO	174; 98; 94; 55	—

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.

Eligibility Criteria

Inclusion Criteria

Wrist circumference: 12 to 20 Cm
At least 5% of the readings shall have Systolic BP =160 mmHg
At least 20% of the readings shall have Systolic BP>=140 mmHg
At least 5% of the readings shall have Diastolic BP =100 mmHg
At least 20% of the readings shall have Diastolic BP>=85 mmHg

Exclusion Criteria

Pregnant Women

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Data sourced from ClinicalTrials.gov (NCT01359748). 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.