Blood PressureNCT01359748
Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO
A study testing Reference sphygmomanometer and Sphygmomanometer under test in people with Blood Pressure, run by Aguiflai Iberica, S.L..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 83 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Reference sphygmomanometer and Sphygmomanometer under test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Mar 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 83 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant Women
About this study
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.
Read the 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.
- Conditions
- Blood Pressure
- Being tested
- Reference sphygmomanometer, Sphygmomanometer under test
- Keywords
- Non Invasive Blood Pressure measurement study.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference sphygmomanometerDevice
Also called *Ref Auscult. sphygm.: RIESTER MINIMUS S/N 20534567
- USED Audible Korotkoff (K5)for Auscultatory sphygmomanometer.
Sphygmomanometer under testDevice
Also called * Multifunction KEITO K7 S/N 1941.
Electronic Oscillometric method.
| Study group | Role | What they receive |
|---|---|---|
| Wrist Size <= 14.25 Cm | Other | * Blood pressure measured using the reference sphygmomanometer.
* Blood pressure measured using the Sphygmomanometer under test. Receives: Device: Reference sphygmomanometer; Device: 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. Receives: Device: Reference sphygmomanometer; Device: 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. Receives: Device: Reference sphygmomanometer; Device: Sphygmomanometer under test |
| Wrist Size >=17.75 Cm | Other | * Blood pressure measured using the reference sphygmomanometer.
* Blood pressure measured using the Sphygmomanometer under test. Receives: Device: Reference sphygmomanometer; Device: Sphygmomanometer under test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aguiflai Iberica, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angel P Ferre, Engineer, Study directorFrancisco B Contreras, Technician, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359748
- Sponsor's protocol ID
- K8-BP-31032011
- Status last verified
- Jul 2014
- First submitted
- 16 May 2011
- Last updated
- 29 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO
- ClinicalTrials.gov ID
- NCT01359748
- Acronym / sponsor ID
- K8-BP-31032011
- Conditions
- Blood Pressure
- Keywords
- Non Invasive Blood Pressure measurement study.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Aguiflai Iberica, S.L.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 25 May 2011 (estimated)
- Results
- Posted 7 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Wrist Size <= 14.25 Cm | Other | Device: Reference sphygmomanometer, Device: Sphygmomanometer under test* Blood pressure measured using the reference sphygmomanometer. * Blood pressure measured using the Sphygmomanometer under test. |
| Wrist Size >=14.26 <16.50 Cm | Other | Device: Reference sphygmomanometer, Device: Sphygmomanometer under test* Blood pressure measured using the reference sphygmomanometer. * Blood pressure measured using the Sphygmomanometer under test. |
| Wrist size >=16.5 <17.75 Cm | Other | Device: Reference sphygmomanometer, Device: Sphygmomanometer under test* Blood pressure measured using the reference sphygmomanometer. * Blood pressure measured using the Sphygmomanometer under test. |
| Wrist Size >=17.75 Cm | Other | Device: Reference sphygmomanometer, Device: Sphygmomanometer under test* Blood pressure measured using the reference sphygmomanometer. * Blood pressure measured using the Sphygmomanometer under test. |
Who may qualify
- Ages
- 18 to 83 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant Women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reference sphygmomanometerAlso: *Ref Auscult. sphygm.: RIESTER MINIMUS S/N 20534567* USED Audible Korotkoff (K5)for Auscultatory sphygmomanometer. | Device | Wrist Size <= 14.25 Cm, Wrist Size >=14.26 <16.50 Cm, Wrist Size >=17.75 Cm, Wrist size >=16.5 <17.75 Cm |
| Sphygmomanometer under testAlso: * Multifunction KEITO K7 S/N 1941.Electronic Oscillometric method. | Device | Wrist Size <= 14.25 Cm, Wrist Size >=14.26 <16.50 Cm, Wrist Size >=17.75 Cm, Wrist size >=16.5 <17.75 Cm |
Primary outcome
BP Measurements Using the Reference Auscultatory Sphygmomanometer
Time frame: Five minutes
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Blood Pressure
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angel P Ferre, Engineer study director
Francisco B Contreras, Technician study chair
Questions about this trial
What is this clinical trial studying?
A study testing Reference sphygmomanometer and Sphygmomanometer under test in people with Blood Pressure, run by Aguiflai Iberica, S.L..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BP Measurements Using the Reference Auscultatory Sphygmomanometer (time frame: Five minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2014.