HealthyNCT00443001
Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias
A study testing Non invasive blood pressure monitor in people with Healthy, run by GE Healthcare at 1 site in United States.
Trial summary
This protocol focuses on the evaluation of the GE noninvasive blood pressure parameter in subjects with dysrhythmias and normal sinus rhythm. The study follows the recommendations of the ANSI/AAMI SP10 Standard. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Non invasive blood pressure monitor
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- signed informed consent
- a patient who is undergoing a specialized procedure such as a surgical procedure or cardiac catheterization, or during critical care monitoring in which a central arterial catheter is in place to determine systolic, diastolic, and/or mean arterial blood pressure values.
- ability to monitor ECG, NIBP and/or pulse oximetry
- presence of atrial fibrillation, atrial flutter, or normal sinus rhythm
Who cannot join
- any subject deemed too unstable, at the clinician's discretion, to participate in the study
- any subject with a cardiac or vascular malformation that results in an abnormal waveform inappropriate to be considered a reference standard
- any subject with a cardiac anomaly that would cause a disparity between aortic pressures and the periphery.
- presence of peripheral vascular disease in arms
- inability to perform a minimum of 4 fast flushes (two at the study beginning and two at the study end) on an arterial catheter or line in order to determine a frequency response. The volume of fluid will not exceed a total pre-specified by the Principal Investigator or designee.
- if the baseline arm to arm mean difference is > 10 mmHg, then the differences will be recorded and evaluated by the Principal Investigator for possible subject exclusion from the data analysis.
- subjects who, at the clinician's discretion, could not tolerate approximately 5 to 12, but possibly up to 25 repeated blood pressures on each arm
Trial locations and contacts
1 site in 1 country.
About this study
This protocol focuses on the evaluation of the GE noninvasive blood pressure parameter in subjects with dysrhythmias and normal sinus rhythm. The study follows the recommendations of the ANSI/AAMI SP10 Standard.
- Conditions
- Healthy
- Being tested
- Non invasive blood pressure monitor
- Keywords
- Non-Invasive Blood Pressure, Sinus Rhythm, Oscillometric, Invasive Blood Pressure, AAMI/ANSI SP10 Standard, Compliance with ANSI/AAMI SP10 2002 standard
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive blood pressure monitorDevice
Updated device and software to improve performance in patients with dysrhythmia
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of early systolic, systolic, and diastolic blood pressure, MAP and pulse rate as collected by an investigational non-invasive blood pressure device versus reference standards
Measured: 1-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Russel Hirsch, MD, Study director, Cardiac Catheterization Laboratory Division of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443001
- Sponsor's protocol ID
- CS 347
- Status last verified
- Jul 2022
- First submitted
- 2 Mar 2007
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias
- ClinicalTrials.gov ID
- NCT00443001
- Acronym / sponsor ID
- CS 347
- Conditions
- Healthy
- Keywords
- Non-Invasive Blood Pressure, Sinus Rhythm, Oscillometric, Invasive Blood Pressure, AAMI/ANSI SP10 Standard, Compliance with ANSI/AAMI SP10 2002 standard
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 5 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol focuses on the evaluation of the GE noninvasive blood pressure parameter in subjects with dysrhythmias and normal sinus rhythm. The study follows the recommendations of the ANSI/AAMI SP10 Standard.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- signed informed consent
- a patient who is undergoing a specialized procedure such as a surgical procedure or cardiac catheterization, or during critical care monitoring in which a central arterial catheter is in place to determine systolic, diastolic, and/or mean arterial blood pressure values.
- ability to monitor ECG, NIBP and/or pulse oximetry
- presence of atrial fibrillation, atrial flutter, or normal sinus rhythm
Key exclusion criteria (7 listed)
- any subject deemed too unstable, at the clinician's discretion, to participate in the study
- any subject with a cardiac or vascular malformation that results in an abnormal waveform inappropriate to be considered a reference standard
- any subject with a cardiac anomaly that would cause a disparity between aortic pressures and the periphery.
- presence of peripheral vascular disease in arms
- inability to perform a minimum of 4 fast flushes (two at the study beginning and two at the study end) on an arterial catheter or line in order to determine a frequency response. The volume of fluid will not exceed a total pre-specified by the Principal Investigator or designee.
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 |
|---|---|---|
| Non invasive blood pressure monitorUpdated device and software to improve performance in patients with dysrhythmia | Device | – |
Primary outcome
Comparison of early systolic, systolic, and diastolic blood pressure, MAP and pulse rate as collected by an investigational non-invasive blood pressure device versus reference standards
Time frame: 1-4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
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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.
Russel Hirsch, MD study director
Cardiac Catheterization Laboratory Division of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive blood pressure monitor in people with Healthy, 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 4 inclusion and 7 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 27 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of early systolic, systolic, and diastolic blood pressure, MAP and pulse rate as collected by an investigational non-invasive blood pressure device versus reference standards (time frame: 1-4 hours). 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 27 Jul 2022.