Analysis of the Arterial Pressure Wave Form Through the Proxima Device

An Open, Non-randomised, Study to Provide Data on the Arterial Pressure Wave Form Obtained Through the Proxima 3 in Patients Who Require the Insertion of an Arterial Line

The purpose of the trial is to confirm that the presence of the Proxima 3 disposable in the arterial line doesn't significantly attenuate the arterial pressure wave form. The principal aim of the trial will be:

• To obtain quantitative data allowing investigation of the pressure wave form obtained in a standard arterial line compared to various arterial lines fitted with the Proxima 3.

Study Overview

• Status: Completed
• Conditions: Local Pressure Effects

Detailed Description

The purpose of this study is to examine the transmission of the arterial pressure wave form through Proxima 3 disposable attached to a configurable parts of the patient's arterial line. The Proxima device has been tested by Intertek as part of the Proxima 2 project and found to comply to BS EN 60601-1 2nd edition "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance". Additional internal tests have also been carried out for clause 51.103, frequency response, from BS EN 60601-2-34(2001).

This study part of the on-going development of the Proxima system which monitors metabolic parameters in critically ill patients using a disposable sensor array. This study builds upon the four clinical trials carried out in the past two years by Sphere Medical in partnership with the NHS (REC references: 10/H1308/53, 10/H0308/113, 11/SW/0166, 12/SW/0175).

This study forms part of the development process for the Proxima family of devices.

The Proxima 3:

• Is a disposable multi-parameter microanalyser
• Is connected into the patient's arterial line.
• Will measure all or some of blood gases, haematocrit and electrolytes and is connected to a small bedside monitor, which displays the results.
• Microanalyser can perform an unlimited number of analyses over a period of up to seventy two hours.
• Will be used as part of a closed system, reducing infection risk and preventing blood loss.

Proxima 3 will enable clinicians to measure blood parameters without leaving the patient's bedside. This will support the ability to respond rapidly to changing conditions in their critically ill patients. The measurements made by the Proxima 3 system have the potential to inform clinical decision support systems and to change, at a fundamental level, the ability of clinicians to improve patient care.

In this study the Proxima 3 is a passive component. It will NOT be connected to the Proxima 3 monitor. NO blood will be taken and NO analysis of the blood analyte concentrations will occur in this study.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United Kingdom
  • Edgbaston
    • City and Borough of Birmingham, Edgbaston, United Kingdom, B15 2WB
      • Queen Elizabeth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated in the Intensive Care or High Dependency Units who require an arterial line to be inserted as standard care

Description

Inclusion Criteria:

• Male and female patients over the age of 18
• Patients will give full informed consent to participate in the study before inclusion.
• All patients who have an arterial line inserted as standard care will be considered for inclusion.

Exclusion Criteria:

• Refusal of consent to participate
• The patient is considered by the investigator to be unsuitable for the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To confirm that siting Proxima 3 in the arterial line does not affect the pressure wave form	The data traces collected from the arterial pressure waveform monitor will undergo quantitative assessment to determine the effect on the pressure wave, if any, by introducing the Proxima 3 device in the system.	10 minutes maximum

Collaborators and Investigators

• Sponsor: Sphere Medical Ltd.
• Investigators: Study Director: Thomas Clutton-Brock, MB ChB FRCP, Queen Elizabeth Hopsital, Birmingham, UK

Publications and helpful links

Helpful Links

• Click here for more information about this study

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: August 21, 2012
• First Submitted That Met QC Criteria: August 21, 2012
• First Posted (Estimate): August 24, 2012

Study Record Updates

• Last Update Posted (Estimate): August 12, 2013
• Last Update Submitted That Met QC Criteria: August 8, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: pressure; arterial; waveform
• Other Study ID Numbers: PROX005