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Comparison of Performance of a Conventional Blood Gas Analyser With the Proxima System

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ClinicalTrials.gov Identifier: NCT01921023
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : November 18, 2014
Sponsor:
Information provided by (Responsible Party):
Sphere Medical Ltd.

Brief 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 Proxima for FDA regulatory clearance.


Condition or disease
Analysis, Event History

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.


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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : September 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014



Primary Outcome Measures :
  1. - 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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,
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921023


Locations
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United Kingdom
Queen Elizabeth Hospital
City and Borough of Birmingham, Edgbaston, United Kingdom, B15 2WB
Sponsors and Collaborators
Sphere Medical Ltd.
Investigators
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Study Director: Thomas Clutton-Brock, MB ChB FRCA FRCP FFICM Queen Elizabeth Hopsital, Birmingham, UK

Additional Information:
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Responsible Party: Sphere Medical Ltd.
ClinicalTrials.gov Identifier: NCT01921023     History of Changes
Other Study ID Numbers: PROX006
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: February 2014

Keywords provided by Sphere Medical Ltd.:
Blood Gas analysis