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Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aguiflai Iberica, S.L.
ClinicalTrials.gov Identifier:
NCT01359748
First received: May 16, 2011
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Blood Pressure
Device: Reference sphygmomanometer
Device: Sphygmomanometer under test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
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:
  • BP Measurements Using the Reference Auscultatory Sphygmomanometer [ Time Frame: Five minutes ] [ Designated as safety issue: No ]

    The subject was measured by the two observers at the same time using the reference sphygmomanometer and double stethoscope.

    The observers agree to take the K5 korotkoff sound. Each observer takes notes of their own measures.


  • BP Measurement Using Multifunction KEITO [ Time Frame: 30 seconds ] [ Designated as safety issue: No ]

    Prior starting the measurement phase using Multifunction KEITO, the under test device was reset before each new measurement.

    The subject has to be at rest at least 60 seconds before be measured.



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)
Arms Assigned Interventions
Wrist Size <= 14.25 Cm
  • Blood pressure measured using the reference sphygmomanometer.
  • Blood pressure measured using the Sphygmomanometer under test.
Device: Reference sphygmomanometer
* USED Audible Korotkoff (K5)for Auscultatory sphygmomanometer.
Other Name: *Ref Auscult. sphygm.: RIESTER MINIMUS S/N 20534567
Device: Sphygmomanometer under test
Electronic Oscillometric method.
Other Name: * Multifunction KEITO K7 S/N 1941.
Wrist Size >=14.26 <16.50 Cm
  • Blood pressure measured using the reference sphygmomanometer.
  • Blood pressure measured using the Sphygmomanometer under test.
Device: Reference sphygmomanometer
* USED Audible Korotkoff (K5)for Auscultatory sphygmomanometer.
Other Name: *Ref Auscult. sphygm.: RIESTER MINIMUS S/N 20534567
Device: Sphygmomanometer under test
Electronic Oscillometric method.
Other Name: * Multifunction KEITO K7 S/N 1941.
Wrist size >=16.5 <17.75 Cm
  • Blood pressure measured using the reference sphygmomanometer.
  • Blood pressure measured using the Sphygmomanometer under test.
Device: Reference sphygmomanometer
* USED Audible Korotkoff (K5)for Auscultatory sphygmomanometer.
Other Name: *Ref Auscult. sphygm.: RIESTER MINIMUS S/N 20534567
Device: Sphygmomanometer under test
Electronic Oscillometric method.
Other Name: * Multifunction KEITO K7 S/N 1941.
Wrist Size >=17.75 Cm
  • Blood pressure measured using the reference sphygmomanometer.
  • Blood pressure measured using the Sphygmomanometer under test.
Device: Reference sphygmomanometer
* USED Audible Korotkoff (K5)for Auscultatory sphygmomanometer.
Other Name: *Ref Auscult. sphygm.: RIESTER MINIMUS S/N 20534567
Device: Sphygmomanometer under test
Electronic Oscillometric method.
Other Name: * Multifunction KEITO K7 S/N 1941.

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 so easily in the public sites.

One of the most important parameter is the Blood Pressure (BP)measurement. To warrant their efficacity and accuracy, 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, particularly about the Blood Pressure (BP) Measurement, have the same efficacy and accuracy as the conventional auscultatory sphygmomanometers.

To include most of the groups of Blood Pressure (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
Criteria

Inclusion Criteria:

  • Wrist circumference: 12 to 20 Cm
  • At least 5% of the readings shall have Systolic BP<=100 mmHg
  • 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<=60 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359748

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

No publications provided

Responsible Party: Aguiflai Iberica, S.L.
ClinicalTrials.gov Identifier: NCT01359748     History of Changes
Other Study ID Numbers: K8-BP-31032011
Study First Received: May 16, 2011
Results First Received: June 2, 2011
Last Updated: July 22, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Aguiflai Iberica, S.L.:
Non Invasive Blood Pressure measurement study.

ClinicalTrials.gov processed this record on November 25, 2014