Status:
COMPLETED
Comparison of Performance of a Conventional Blood Gas Analyser With the Proxima System
Lead Sponsor:
Sphere Medical Ltd.
Conditions:
Analysis, Event History
Eligibility:
All Genders
18+ years
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 surve...
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 conditio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01921023
Start Date
September 1 2014
End Date
October 1 2014
Last Update
November 18 2014
Active Locations (1)
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1
Queen Elizabeth Hospital
City and Borough of Birmingham, Edgbaston, United Kingdom, B15 2WB