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Clinical Study About Blood Pressure Measurement Efficacy on Multifunction Keito

This study has been completed.
Sponsor:
Information provided by:
Aguiflai Iberica, S.L.
ClinicalTrials.gov Identifier:
NCT01359748
First received: May 16, 2011
Last updated: May 24, 2011
Last verified: May 2011
History of Changes
  Purpose

The purpose of this trial is to determine the accuracy of the BP measurement of multifunction Keito devices under test requirements of the Standard ANSI/AAMI/ISO 81060-2:2009.


Condition
The Focus of Study is to Determine Efficiency and Accuracy of the Multifunction Keito Under the ANSI/AAMI/ISO 81060-2:2009.

Study Type: Observational
Official Title: Clinical Study About Blood Pressure Measurement Efficacy on Multifunction Keito

Further study details as provided by Aguiflai Iberica, S.L.:

Primary Outcome Measures:
  • Operator measurements using the Same Arm sequential method as indicated on [5.2.4.2] of the Standard applied. [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    Each patient has to be measured by the reference auscultatory sphygmomanometer three times by the two different observers using a double stethoscope. The observers have accorded to use the K5 korotkoff Sound. Between each measurement, the patient has been relaxed at least 60 sec.


Secondary Outcome Measures:
  • Multifunction Keito BP measurement.[5.2.4.2] of the standard applied [ Time Frame: Two Weeks. ] [ Designated as safety issue: No ]
    The patient has been measured three times by the device under test. Between each measurement, the patient has been relaxed at least 60 sec.


Enrollment: 89
Study Start Date: March 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Wrist Size <= 14,25 cm
Population with wrist circumference which lies within the lower quarter of the specified range of use of the cuff.
Wrist Size <=16,4 Cm
Population with wrist circumference which lies within the lower Half of the specified range of use of the cuff.
Wrist size >=16,5 Cm
Population with wrist circumference which lies within the Upper Half of the specified range of use of the cuff.
Wrist Size >=17,75
Population with wrist circumference which lies within the Upper Quarter of the specified range of use of the cuff.

Detailed Description:

Nowadays is important controlling our basic health parameters. Due this, the multifunction Keito Devices was designed to offer to the general public a convenient way to do soeasily in the public sites.

One of the most important parameter is the BP measurement. To warrant their efficacity and accuracity, was essential to perform this trial to ensure that the measurements obtained meet with the requirements of the specific U.S. standard about Non-invasive sphygmomanometers.

By Validating with auscultatory reference sphygmomanometer, as defined on the ANSI/AAMI/ISO 81060-2:2009 , we have been intending to demonstrate that the multifunction Keito devices, particulary about the BP Measurement, have the same efficacy and accuracy as the conventional auscultatory sphygmomanometers.

To include most of the groups of BP measurements types on this clinical trial, a great variety of BP ranges have been selected, always in accordance with the standard.

  Eligibility

Ages Eligible for Study:   18 Years to 83 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The population has been selected and defined prior by their wrist size. Once all the measures have been performed, they were clasified according to their sistolic and diastolic measures ranges, following the standard requirements.

Criteria

Inclusion Criteria:

  • Wrist circumference: 12 to 20 Cm
  • Systolic <=100 mmHg
  • Systolic >=160 mmHg
  • Systolic >=140 mmHg
  • Diastolic <=60 mmHg
  • Diastolic >=100 mmHg
  • Diastolic >=85 mmHg

Exclusion Criteria:

  • Pregnant Women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359748

Sponsors and Collaborators
Aguiflai Iberica, S.L.
Investigators
Study Director: Angel P Ferre, Telecommunications Engineer
Study Chair: Francisco B Contreras, Electronic Technician
  More Information

No publications provided

Responsible Party: Angel Pons Ferre / Technical Head, Aguiflai Iberica, s.l
ClinicalTrials.gov Identifier: NCT01359748     History of Changes
Other Study ID Numbers: K8-BP-31032011
Study First Received: May 16, 2011
Last Updated: May 24, 2011
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Aguiflai Iberica, S.L.:
Non Invasive Blood Pressure measurement study.
Validation of Blood Pressure measurement under ANSI/AAMI/ISO 81060-2

ClinicalTrials.gov processed this record on May 19, 2013