Local Pressure EffectsNCT01672073
Analysis of the Arterial Pressure Wave Form Through the Proxima Device
An observational study of Local Pressure Effects, run by Sphere Medical Ltd. at 1 site in United Kingdom.
Trial summary
The purpose of the trial is to confirm that the presence of the Proxima 3 disposable in the arterial line doesn't significantly attenuate the arterial pressure wave form. The principal aim of the trial will be: To obtain quantitative data allowing investigation of the pressure wave form obtained in a standard arterial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Local Pressure Effects
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Feb 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated in the Intensive Care or High Dependency Units who require an arterial line to be inserted as standard care
Who may be able to join
- Male and female patients over the age of 18
- Patients will give full informed consent to participate in the study before inclusion.
- All patients who have an arterial line inserted as standard care will be considered for inclusion.
Who cannot join
- Refusal of consent to participate
- The patient is considered by the investigator to be unsuitable for the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth Hospital
City and Borough of Birmingham, Edgbaston, B15 2WB
About this study
Official title: An Open, Non-randomised, Study to Provide Data on the Arterial Pressure Wave Form Obtained Through the Proxima 3 in Patients Who Require the Insertion of an Arterial Line
The purpose of the trial is to confirm that the presence of the Proxima 3 disposable in the arterial line doesn't significantly attenuate the arterial pressure wave form. The principal aim of the trial will be:
- To obtain quantitative data allowing investigation of the pressure wave form obtained in a standard arterial line compared to various arterial lines fitted with the Proxima 3.
Read the detailed description
The purpose of this study is to examine the transmission of the arterial pressure wave form through Proxima 3 disposable attached to a configurable parts of the patient's arterial line. The Proxima device has been tested by Intertek as part of the Proxima 2 project and found to comply to BS EN 60601-1 2nd edition "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance". Additional internal tests have also been carried out for clause 51.103, frequency response, from BS EN 60601-2-34(2001).
This study part of the on-going development of the Proxima system which monitors metabolic parameters in critically ill patients using a disposable sensor array. This study builds upon the four clinical trials carried out in the past two years by Sphere Medical in partnership with the NHS (REC references: 10/H1308/53, 10/H0308/113, 11/SW/0166, 12/SW/0175).
This study forms part of the development process for the Proxima family of devices.
The Proxima 3:
- Is a disposable multi-parameter microanalyser
- Is connected into the patient's arterial line.
- Will measure all or some of blood gases, haematocrit and electrolytes and is connected to a small bedside monitor, which displays the results.
- Microanalyser can perform an unlimited number of analyses over a period of up to seventy two hours.
- Will be used as part of a closed system, reducing infection risk and preventing blood loss.
Proxima 3 will enable clinicians to measure blood parameters without leaving the patient's bedside. This will support the ability to respond rapidly to changing conditions in their critically ill patients. The measurements made by the Proxima 3 system have the potential to inform clinical decision support systems and to change, at a fundamental level, the ability of clinicians to improve patient care.
In this study the Proxima 3 is a passive component. It will NOT be connected to the Proxima 3 monitor. NO blood will be taken and NO analysis of the blood analyte concentrations will occur in this study.
- Conditions
- Local Pressure Effects
- Keywords
- pressure, waveform, arterial
What is being measured
The primary outcome is the main question the study is designed to answer.
To confirm that siting Proxima 3 in the arterial line does not affect the pressure wave form
The data traces collected from the arterial pressure waveform monitor will undergo quantitative assessment to determine the effect on the pressure wave, if any, by introducing the Proxima 3 device in the system.
Measured: 10 minutes maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startJan 2013
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Pressure EffectsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sphere Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Clutton-Brock, MB ChB FRCP, Study director, Queen Elizabeth Hopsital, Birmingham, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672073
- Sponsor's protocol ID
- PROX005
- Status last verified
- Aug 2013
- First submitted
- 21 Aug 2012
- Last updated
- 12 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Non-randomised, Study to Provide Data on the Arterial Pressure Wave Form Obtained Through the Proxima 3 in Patients Who Require the Insertion of an Arterial Line
- ClinicalTrials.gov ID
- NCT01672073
- Acronym / sponsor ID
- PROX005
- Conditions
- Local Pressure Effects
- Keywords
- pressure, waveform, arterial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sphere Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 Aug 2012 (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.
The purpose of the trial is to confirm that the presence of the Proxima 3 disposable in the arterial line doesn't significantly attenuate the arterial pressure wave form. The principal aim of the trial will be:
- To obtain quantitative data allowing investigation of the pressure wave form obtained in a standard arterial line compared to various arterial lines fitted with the Proxima 3.
Detailed description
The purpose of this study is to examine the transmission of the arterial pressure wave form through Proxima 3 disposable attached to a configurable parts of the patient's arterial line. The Proxima device has been tested by Intertek as part of the Proxima 2 project and found to comply to BS EN 60601-1 2nd edition "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance". Additional internal tests have also been carried out for clause 51.103, frequency response, from BS EN 60601-2-34(2001).
This study part of the on-going development of the Proxima system which monitors metabolic parameters in critically ill patients using a disposable sensor array. This study builds upon the four clinical trials carried out in the past two years by Sphere Medical in partnership with the NHS (REC references: 10/H1308/53, 10/H0308/113, 11/SW/0166, 12/SW/0175).
This study forms part of the development process for the Proxima family of devices.
The Proxima 3:
- Is a disposable multi-parameter microanalyser
- Is connected into the patient's arterial line.
- Will measure all or some of blood gases, haematocrit and electrolytes and is connected to a small bedside monitor, which displays the results.
- Microanalyser can perform an unlimited number of analyses over a period of up to seventy two hours.
- Will be used as part of a closed system, reducing infection risk and preventing blood loss.
Proxima 3 will enable clinicians to measure blood parameters without leaving the patient's bedside. This will support the ability to respond rapidly to changing conditions in their critically ill patients. The measurements made by the Proxima 3 system have the potential to inform clinical decision support systems and to change, at a fundamental level, the ability of clinicians to improve patient care.
In this study the Proxima 3 is a passive component. It will NOT be connected to the Proxima 3 monitor. NO blood will be taken and NO analysis of the blood analyte concentrations will occur in this study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated in the Intensive Care or High Dependency Units who require an arterial line to be inserted as standard care
Key inclusion criteria (3 listed)
- Male and female patients over the age of 18
- Patients will give full informed consent to participate in the study before inclusion.
- All patients who have an arterial line inserted as standard care will be considered for inclusion.
Key exclusion criteria (2 listed)
- Refusal of consent to participate
- The patient is considered by the investigator to be unsuitable for 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.
Primary outcome
To confirm that siting Proxima 3 in the arterial line does not affect the pressure wave form
Time frame: 10 minutes maximum
The data traces collected from the arterial pressure waveform monitor will undergo quantitative assessment to determine the effect on the pressure wave, if any, by introducing the Proxima 3 device in the system.
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 12 Aug 2013.
- Click here for more information about this studyLink provided by the sponsor.
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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.
Thomas Clutton-Brock, MB ChB FRCP study director
Queen Elizabeth Hopsital, Birmingham, UK
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 Local Pressure Effects, run by Sphere Medical Ltd. at 1 site in United Kingdom.
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 2 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 12 Aug 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 Kingdom. 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?
To confirm that siting Proxima 3 in the arterial line does not affect the pressure wave form (time frame: 10 minutes maximum). 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 12 Aug 2013.