Analysis, Event HistoryNCT01921023
Comparison of Performance of a Conventional Blood Gas Analyser With the Proxima System
An observational study of Analysis, Event History, run by Sphere Medical Ltd. at 1 site in United Kingdom.
Trial summary
This clinical investigation is being undertaken to examine the performance of the CE marked Proxima System - a patient attached blood gas analyser. The study forms an element of the Post Market surveillance plan for the Proxima system and will also generate method comparison data to allow Sphere Medical to submit the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analysis, Event History
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Oct 2014
- 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 Unit, High Dependency Unit or Operating Theatre who require an arterial line to be inserted as standard care
Who may be able to join
- Male and female patients ≥18 years old
- Patients who have (or will have) an arterial line, which was (will be) inserted for clinical need, will be considered for inclusion in this study
- Patients who give informed consent (or their personal/nominated consultee) to participate in the study
- Patients who are likely to have an arterial line for at least 48 hours.
Who cannot join
- Patients not indicated or contraindicated for an arterial line
- Refusal of consent by a patient or their personal/nominated consultee to participate
- Not for use with patients with uncorrected hyperphosphataemia, hypocalcaemia or hypercalcaemia.
- The patient is considered by the investigator to be unsuitable for the study
- Arterial line location/placement is not dictated by this study, however the following criteria should be considered when deciding if arterial catheter placement is suitable, including but not limited to:
- peripheral vascular disease,
Show all 10Show fewer
- history of placement site neuropathy or chronic pain,
- history of placement extremity coagulopathy or clot formation,
- history of vascular surgery on same extremity as catheter placement (and/or vascular grafts)
- patients with a plan for perioperative anticoagulation. These patients are at increased risk of known complications such as bleeding and arteriospasm and should be excluded in order to mitigate patient study risk.
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 a Comparison of Data From a Conventional Blood Gas Analyser With Those Obtained From the CE Marked Proxima System
This clinical investigation is being undertaken to examine the performance of the CE marked Proxima System - a patient attached blood gas analyser.
The study forms an element of the Post Market surveillance plan for the Proxima system and will also generate method comparison data to allow Sphere Medical to submit the Proxima for FDA regulatory clearance.
Read the detailed description
The PROX006 study is an open and non-randomised study that will be conducted to assess the performance of the Proxima (a CE marked Medical Device)on a wide range of patients with a variety of conditions. This study will allow the performance of the Proxima and the institution's conventional blood gas analyser to be compared when used in the Intensive Care Unit and Operating Theatre.
The PROX006 investigation is an observational method comparison study - the results obtained from the Proxima will be compared with those obtained on the institution's conventional blood gas analyser (BGA). The potential for bias by the user will be negated in this study by directly comparing the results from the BGA and Proxima.
The data/results documented in the Case Report Form (CRF) will be verified during monitoring visits.
- Conditions
- Analysis, Event History
- Keywords
- Blood Gas analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
- To obtain quantitative data using patient arterial blood to allow the comparison of Proxima readings with those obtained from a standard commercially available blood gas analyser in a clinical setting.
Blood gas samples will be analysed on the Proxima and institution's Blood Gas Analyser.
Additional samples for serum phosphate analysis will be draw and analysed every 24 hours for 3 days.
1 day follow up period after the Proxima system has been disconnected from the patient
Measured: 4 days for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startSep 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analysis, Event HistoryStudies 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
- 21 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 FRCA FRCP FFICM, Study director, Queen Elizabeth Hopsital, Birmingham, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921023
- Sponsor's protocol ID
- PROX006
- Status last verified
- Feb 2014
- First submitted
- 8 Aug 2013
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Non-randomised, Study to Provide a Comparison of Data From a Conventional Blood Gas Analyser With Those Obtained From the CE Marked Proxima System
- ClinicalTrials.gov ID
- NCT01921023
- Acronym / sponsor ID
- PROX006
- Conditions
- Analysis, Event History
- Keywords
- Blood Gas analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Sphere Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 13 Aug 2013 (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 clinical investigation is being undertaken to examine the performance of the CE marked Proxima System - a patient attached blood gas analyser.
The study forms an element of the Post Market surveillance plan for the Proxima system and will also generate method comparison data to allow Sphere Medical to submit the Proxima for FDA regulatory clearance.
Detailed description
The PROX006 study is an open and non-randomised study that will be conducted to assess the performance of the Proxima (a CE marked Medical Device)on a wide range of patients with a variety of conditions. This study will allow the performance of the Proxima and the institution's conventional blood gas analyser to be compared when used in the Intensive Care Unit and Operating Theatre.
The PROX006 investigation is an observational method comparison study - the results obtained from the Proxima will be compared with those obtained on the institution's conventional blood gas analyser (BGA). The potential for bias by the user will be negated in this study by directly comparing the results from the BGA and Proxima.
The data/results documented in the Case Report Form (CRF) will be verified during monitoring visits.
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 Unit, High Dependency Unit or Operating Theatre who require an arterial line to be inserted as standard care
Key inclusion criteria (4 listed)
- Male and female patients ≥18 years old
- Patients who have (or will have) an arterial line, which was (will be) inserted for clinical need, will be considered for inclusion in this study
- Patients who give informed consent (or their personal/nominated consultee) to participate in the study
- Patients who are likely to have an arterial line for at least 48 hours.
Key exclusion criteria (10 listed)
- Patients not indicated or contraindicated for an arterial line
- Refusal of consent by a patient or their personal/nominated consultee to participate
- Not for use with patients with uncorrected hyperphosphataemia, hypocalcaemia or hypercalcaemia.
- The patient is considered by the investigator to be unsuitable for the study
- Arterial line location/placement is not dictated by this study, however the following criteria should be considered when deciding if arterial catheter placement is suitable, including but not limited to:
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 obtain quantitative data using patient arterial blood to allow the comparison of Proxima readings with those obtained from a standard commercially available blood gas analyser in a clinical setting.
Time frame: 4 days for each patient
Blood gas samples will be analysed on the Proxima and institution's Blood Gas Analyser. Additional samples for serum phosphate analysis will be draw and analysed every 24 hours for 3 days. 1 day follow up period after the Proxima system has been disconnected from the patient
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 18 Nov 2014.
- Visit above web address 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 FRCA FRCP FFICM 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 Analysis, Event History, 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 4 inclusion and 10 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 18 Nov 2014. 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 obtain quantitative data using patient arterial blood to allow the comparison of Proxima readings with those obtained from a standard commercially available blood gas analyser in a clinical setting. (time frame: 4 days for each patient). 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 18 Nov 2014.