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
1 other identifier
observational
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2012
CompletedFirst Posted
Study publicly available on registry
August 24, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedAugust 12, 2013
August 1, 2013
1 month
August 21, 2012
August 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
Patients treated in the Intensive Care or High Dependency Units who require an arterial line to be inserted as standard care
You may qualify if:
- Male and female patients over the age of 18
You may not qualify if:
- Refusal of consent to participate
- The patient is considered by the investigator to be unsuitable for the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen Elizabeth Hospital
City and Borough of Birmingham, Edgbaston, B15 2WB, United Kingdom
Related Links
Study Officials
- STUDY DIRECTOR
Thomas Clutton-Brock, MB ChB FRCP
Queen Elizabeth Hopsital, Birmingham, UK
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2012
First Posted
August 24, 2012
Study Start
January 1, 2013
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
August 12, 2013
Record last verified: 2013-08