Analysis of the Arterial Pressure Wave Form Through the Proxima Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01672073
Recruitment Status : Completed
First Posted : August 24, 2012
Last Update Posted : August 12, 2013
Information provided by (Responsible Party):
Sphere Medical Ltd.

Brief Summary:

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.

Condition or disease
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
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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
Study Start Date : January 2013
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Primary Outcome Measures :
  1. To confirm that siting Proxima 3 in the arterial line does not affect the pressure wave form [ Time Frame: 10 minutes maximum ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01672073

United Kingdom
Queen Elizabeth Hospital
City and Borough of Birmingham, Edgbaston, United Kingdom, B15 2WB
Sponsors and Collaborators
Sphere Medical Ltd.
Study Director: Thomas Clutton-Brock, MB ChB FRCP Queen Elizabeth Hopsital, Birmingham, UK

Additional Information:
Responsible Party: Sphere Medical Ltd. Identifier: NCT01672073     History of Changes
Other Study ID Numbers: PROX005
First Posted: August 24, 2012    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: August 2013

Keywords provided by Sphere Medical Ltd.: