Blood PressureNCT01546285
B40 Non-Invasive Blood Pressure Equivalency Study
A study testing Blood Pressure Readings on B40 Patient Monitor in people with Blood Pressure, run by GE Healthcare at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device. Read more about this study
- Who is it for?
- Ages 3 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Blood Pressure Readings on B40 Patient Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Mar 2012
- 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 3 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Ability to provide written informed consent or have a legally authorized representative including a parent or guardian provide written informed consent
- Within the age range from older than 3 years old to 75 years old (adult and child)
- Ability to maintain proper placement of cuff and/or probe and/or sensor
Who cannot join
- Neonates (ages 0-29 days) and infants (30 days to 3 years old) shall be excluded
- Any subject deemed too unstable, by clinician's discretion, or for another reason deemed unacceptable for study by the clinician
- Known dysrhythmias (when applicable)
- Known disease state that compromises circulation to the extremity
- Vigorous exercise prior to participating in the study
- Excessive movement or excitability causing false values or no determinations
- Known allergy to latex when latex products will be in contact with subject
- Pregnant females
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.
Read the detailed description
Automated non-invasive blood pressure devices have a long history. These devices first made their appearance in the mid-1970's. Since that time, there have been many improvements in the performance of these devices. Specifically, when making changes to the algorithms that control these devices, the goals are: to improve accuracy and precision in the blood pressure (BP) estimates, to reduce the time needed to determine the BP estimates, to increase comfort for the patient, and to work through artifacts and arrhythmias that are often present in the clinical environment.
The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.
- Conditions
- Blood Pressure
- Being tested
- Blood Pressure Readings on B40 Patient Monitor
- Keywords
- The focus of this study is to demonstrate that DINAMAP® SuperSTATTM NIBP algorithm has been implemented correctly without performance losses to the B40 monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Pressure Readings on B40 Patient MonitorDevice
Simultaneous blood pressure reading on the Investigational B40 patient monitor and DINAMAP PRO1000 patient monitor
| Study group | Role | What they receive |
|---|---|---|
| Blood Pressure Reading | Experimental | Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings Receives: Device: Blood Pressure Readings on B40 Patient Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements
The primary endpoints are the difference in systolic, diastolic and mean blood pressure values between the B40 Monitor and PRO1000. The mean of the difference should be no more than 5mmHg and the standard deviation of the difference should be no more than 8mmHg per the AAMI SP-10 standard.
Measured: End of each blood pressure reading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2012
- Study completionMar 2012
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.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546285
- Sponsor's protocol ID
- 118.04-2011-GES-0002
- Status last verified
- May 2013
- First submitted
- 28 Feb 2012
- Last updated
- 21 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B40 Non-Invasive Blood Pressure Equivalency Study
- ClinicalTrials.gov ID
- NCT01546285
- Acronym / sponsor ID
- 118.04-2011-GES-0002
- Conditions
- Blood Pressure
- Keywords
- The focus of this study is to demonstrate that DINAMAP® SuperSTATTM NIBP algorithm has been implemented correctly without performance losses to the B40 monitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Posted 21 Jun 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 study is to demonstrate equivalency of the GE Healthcare B40 Patient Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.
Detailed description
Automated non-invasive blood pressure devices have a long history. These devices first made their appearance in the mid-1970's. Since that time, there have been many improvements in the performance of these devices. Specifically, when making changes to the algorithms that control these devices, the goals are: to improve accuracy and precision in the blood pressure (BP) estimates, to reduce the time needed to determine the BP estimates, to increase comfort for the patient, and to work through artifacts and arrhythmias that are often present in the clinical environment.
The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood Pressure Reading | Experimental | Device: Blood Pressure Readings on B40 Patient MonitorSimultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings |
Who may qualify
- Ages
- 3 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to provide written informed consent or have a legally authorized representative including a parent or guardian provide written informed consent
- Within the age range from older than 3 years old to 75 years old (adult and child)
- Ability to maintain proper placement of cuff and/or probe and/or sensor
Key exclusion criteria (8 listed)
- Neonates (ages 0-29 days) and infants (30 days to 3 years old) shall be excluded
- Any subject deemed too unstable, by clinician's discretion, or for another reason deemed unacceptable for study by the clinician
- Known dysrhythmias (when applicable)
- Known disease state that compromises circulation to the extremity
- Vigorous exercise prior to participating in the study
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 |
|---|---|---|
| Blood Pressure Readings on B40 Patient MonitorSimultaneous blood pressure reading on the Investigational B40 patient monitor and DINAMAP PRO1000 patient monitor | Device | Blood Pressure Reading |
Primary outcome
Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements
Time frame: End of each blood pressure reading
The primary endpoints are the difference in systolic, diastolic and mean blood pressure values between the B40 Monitor and PRO1000. The mean of the difference should be no more than 5mmHg and the standard deviation of the difference should be no more than 8mmHg per the AAMI SP-10 standard.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Pressure Readings on B40 Patient Monitor in people with Blood Pressure, run by GE Healthcare at 1 site in United States.
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 3 inclusion and 8 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 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 21 Jun 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?
Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements (time frame: End of each blood pressure reading). 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 21 Jun 2013.