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.
Study Type
OBSERVATIONAL
Enrollment
21
Queen Elizabeth Hospital
City and Borough of Birmingham, Edgbaston, United Kingdom
- 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
Time frame: 4 days for each patient
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.