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

NCT01921023 | Completed

• 1 other identifier: PROX006
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Analysis, Event History

Keywords

Blood Gas analysis

Outcome Measures

Primary Outcomes (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.

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Male and female patients ≥18 years old
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sphere Medical Ltd.: lead

Study Sites (1)

Queen Elizabeth Hospital

City and Borough of Birmingham, Edgbaston, B15 2WB, United Kingdom

Location

Related Links

• Visit above web address more information about this study

Study Officials

• Thomas Clutton-Brock, MB ChB FRCA FRCP FFICM

  Queen Elizabeth Hopsital, Birmingham, UK

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: August 13, 2013
• Study Start: September 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 18, 2014

Record last verified: 2014-02

Locations

GB (1)