Non-invasive Blood PressureNCT00730119
Evaluation Of The GE Monitor Product Line
An observational study of Non-invasive Blood Pressure and Temperature, run by GE Healthcare at 1 site in United States.
Trial summary
This investigation is a multi-center study that will demonstrate that the GE Monitor meets equivalency and/or accuracy and/or performance criteria. This investigation will compare the test device(s) to itself, or one of the reference parameters, or a combination of parameters, including NIBP, temperature, SpO2… Read more about this study
- Who is it for?
- Ages 1 minute and olderHealthy volunteers can take part
- Conditions the study is for
- Non-invasive Blood Pressure, Temperature, SpO2
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2001to May 2010
- Phase
- Observational
- 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 1 minute and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All populations (neonatal, pediatrics, and adults).
Who may be able to join
- Signed informed consent from subject and/or guardian
- Ability to maintain proper placement of cuff and/or probe and/or sensor
- Presence of atrial fibrillation or other irregular heart rhythm (when applicable)
- Ability to single or dual monitor NIBP, ECG, and/or SpO2, whether or not already being monitored for any or all of these parameters (SuperSTAT development study only)
Who cannot join
- 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 or medical condition that A) compromises circulation to the extremity, B) compromises musculo-skeletal integrity, or C) otherwise contraindicates use of a NIBP cuff and/or SpO2 sensor on an extremity or ECG patches on skin
- 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
Show all 14Show fewer
- Subjects who have eaten, drank, smoked or chewed gum in the preceding half hour (temperature parameter only)
- Nasal/septal defects, cold and/or allergies that would not allow the subject to breathe through their nose (temperature parameter only)
- Subjects with whom flammable anesthetics will be used.
- Adult/pediatric subjects,(greater than 1 year of age) who, at the clinician's discretion, could not tolerate approximately 12, but no more than 25 blood pressures on each extremity
- Pediatric/neonatal subjects,(less than 1 year of age) who, at the clinician's discretion, could not tolerate approximately 10, but no more than 12 blood pressures on each extremity
- Presence of pacemaker which makes the atrial fibrillation rhythm indistinguishable
- Subject's limb circumference is outside of the manufacturer's recommended cuff range
- Subject has Korotkoff sounds that persist to nearly zero (when applicable)
Trial locations and contacts
1 site in 1 country.
About this study
This investigation is a multi-center study that will demonstrate that the GE Monitor meets equivalency and/or accuracy and/or performance criteria. This investigation will compare the test device(s) to itself, or one of the reference parameters, or a combination of parameters, including NIBP, temperature, SpO2, respirations, and ECG.
- Conditions
- Non-invasive Blood Pressure, Temperature, SpO2, Respiration, ECG
- Keywords
- Non-invasive Blood Pressure (NIBP), GE Monitor, Temperature, SpO2, Respiration, ECG
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neonates | Subjects ages birth to 30 days | |
| Infants | Subjects aged >30 days to 2 years | |
| Adults | Subjects aged 18 years of age or older |
What is being measured
The primary outcome is the main question the study is designed to answer.
This investigation will compare values from the test device(s) to itself, or one of the reference parameters, or a combination of parameters, including NIBP, temperature, SpO2, respirations, and ECG.
Measured: unlimited
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startOct 2001
- Primary completionMar 2010
- Study completionMay 2010
Why it stopped: Terminated due to lack of enrollment at target sites
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-invasive 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean D Sesing, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730119
- Sponsor's protocol ID
- CS 327
- Status last verified
- Aug 2017
- First submitted
- 5 Aug 2008
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The GE Monitor Product Line
- ClinicalTrials.gov ID
- NCT00730119
- Acronym / sponsor ID
- CS 327
- Conditions
- Non-invasive Blood Pressure, Temperature, SpO2, Respiration, ECG
- Keywords
- Non-invasive Blood Pressure (NIBP), GE Monitor, Temperature, SpO2, Respiration, ECG
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Terminated due to lack of enrollment at target sites
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Oct 2001 (actual)
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 8 Aug 2008 (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 investigation is a multi-center study that will demonstrate that the GE Monitor meets equivalency and/or accuracy and/or performance criteria. This investigation will compare the test device(s) to itself, or one of the reference parameters, or a combination of parameters, including NIBP, temperature, SpO2, respirations, and ECG.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neonates | – | –Subjects ages birth to 30 days |
| Infants | – | –Subjects aged >30 days to 2 years |
| Adults | – | –Subjects aged 18 years of age or older |
Who may qualify
- Ages
- 1 minute and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All populations (neonatal, pediatrics, and adults).
Key inclusion criteria (4 listed)
- Signed informed consent from subject and/or guardian
- Ability to maintain proper placement of cuff and/or probe and/or sensor
- Presence of atrial fibrillation or other irregular heart rhythm (when applicable)
- Ability to single or dual monitor NIBP, ECG, and/or SpO2, whether or not already being monitored for any or all of these parameters (SuperSTAT development study only)
Key exclusion criteria (14 listed)
- 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 or medical condition that A) compromises circulation to the extremity, B) compromises musculo-skeletal integrity, or C) otherwise contraindicates use of a NIBP cuff and/or SpO2 sensor on an extremity or ECG patches on skin
- Vigorous exercise prior to participating in the study
- Excessive movement or excitability causing false values or no determinations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
This investigation will compare values from the test device(s) to itself, or one of the reference parameters, or a combination of parameters, including NIBP, temperature, SpO2, respirations, and ECG.
Time frame: unlimited
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
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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.
Jean D Sesing study director
GE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-invasive Blood Pressure and Temperature, 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 14 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: withdrawn, as of the sponsor's last update on 8 Aug 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
This investigation will compare values from the test device(s) to itself, or one of the reference parameters, or a combination of parameters, including NIBP, temperature, SpO2, respirations, and ECG. (time frame: unlimited). 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 8 Aug 2017.