NCT01359748

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

November 7, 2013

Completed
Last Updated

July 29, 2014

Status Verified

July 1, 2014

Enrollment Period

Same day

First QC Date

May 16, 2011

Results QC Date

June 2, 2011

Last Update Submit

July 22, 2014

Conditions

Blood Pressure

Keywords

Non Invasive Blood Pressure measurement study.

Outcome Measures

Primary Outcomes (2)

  • BP Measurements Using the Reference Auscultatory Sphygmomanometer

    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.

    Five minutes

  • BP Measurement Using Multifunction KEITO

    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.

    30 seconds

Study Arms (4)

Wrist Size <= 14.25 Cm

OTHER

* Blood pressure measured using the reference sphygmomanometer. * Blood pressure measured using the Sphygmomanometer under test.

Device: Reference sphygmomanometerDevice: Sphygmomanometer under test

Wrist Size >=14.26 <16.50 Cm

OTHER

* Blood pressure measured using the reference sphygmomanometer. * Blood pressure measured using the Sphygmomanometer under test.

Device: Reference sphygmomanometerDevice: Sphygmomanometer under test

Wrist size >=16.5 <17.75 Cm

OTHER

* Blood pressure measured using the reference sphygmomanometer. * Blood pressure measured using the Sphygmomanometer under test.

Device: Reference sphygmomanometerDevice: Sphygmomanometer under test

Wrist Size >=17.75 Cm

OTHER

* Blood pressure measured using the reference sphygmomanometer. * Blood pressure measured using the Sphygmomanometer under test.

Device: Reference sphygmomanometerDevice: Sphygmomanometer under test

Interventions

Reference sphygmomanometerDEVICE

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

Also known as: *Ref Auscult. sphygm.: RIESTER MINIMUS S/N 20534567
Wrist Size <= 14.25 CmWrist Size >=14.26 <16.50 CmWrist Size >=17.75 CmWrist size >=16.5 <17.75 Cm
Sphygmomanometer under testDEVICE

Electronic Oscillometric method.

Also known as: * Multifunction KEITO K7 S/N 1941.
Wrist Size <= 14.25 CmWrist Size >=14.26 <16.50 CmWrist Size >=17.75 CmWrist size >=16.5 <17.75 Cm

Eligibility Criteria

Age18 Years - 83 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant Women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Results Point of Contact

Title
Angel Pons Ferré
Organization
Aguiflai Iberica, SL
calidad@keito.com
+34 93 7540370

Study Officials

  • Angel P Ferre, Engineer

    STUDY DIRECTOR

  • Francisco B Contreras, Technician

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2011

First Posted

May 25, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

July 29, 2014

Results First Posted

November 7, 2013

Record last verified: 2014-07