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
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|
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 Type :||Observational|
|Actual Enrollment :||21 participants|
|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|
- - 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
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
|Queen Elizabeth Hospital|
|City and Borough of Birmingham, Edgbaston, United Kingdom, B15 2WB|
|Study Director:||Thomas Clutton-Brock, MB ChB FRCA FRCP FFICM||Queen Elizabeth Hopsital, Birmingham, UK|