Analysis of the Arterial Pressure Wave Form Through the Proxima Device

Local Pressure Effects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01672073
• Other study ID #: PROX005
• Status: Completed
• Phase: N/A
• First received: August 21, 2012
• Last updated: August 8, 2013
• Start date: January 2013
• Est. completion date: February 2013

Study information

• Verified date: August 2013
• Source: Sphere Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Local Pressure Effects

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Hospital	City and Borough of Birmingham	Edgbaston

Sponsors (1)

Lead Sponsor	Collaborator
Sphere Medical Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

External Links

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