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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.
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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| Measure | Description | Time Frame |
|---|---|---|
| - 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 | 4 days for each patient |
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Inclusion Criteria:
Exclusion Criteria:
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:
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Patients treated in the Intensive Care Unit, High Dependency Unit or Operating Theatre who require an arterial line to be inserted as standard care
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Clutton-Brock, MB ChB FRCA FRCP FFICM | Queen Elizabeth Hopsital, Birmingham, UK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Hospital | City and Borough of Birmingham | Edgbaston | B15 2WB | United Kingdom |
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| Label | URL |
|---|---|
| Visit above web address more information about this study | View source |
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