Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000527369
Ethics application status
Approved
Date submitted
8/09/2008
Date registered
15/10/2008
Date last updated
16/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Central Venous Pressure Estimation by Compression Sonography
Scientific title
Central Venous Pressure Estimation by Compression Sonography in patients with central venous catheters
Secondary ID [1] 280491 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central venous pressure (CVP) estimation 3652 0
Condition category
Condition code
Anaesthesiology 3820 3820 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Non invasive central venous pressure measurement by compression sonography (veins are compressed with an ultrasound probe until the opposite sides touch). Measurements will be repeated until a consistent result is obtained (no resting period). The procedure is estimated to take 10 minutes. There is no specific time for when this measurements will be taken (it will be based upon mutual convenience).
Intervention code [1] 3368 0
Diagnosis / Prognosis
Intervention code [2] 3447 0
Diagnosis / Prognosis
Comparator / control treatment
Invasive measurement of central venous pressure via a central venous catheter (invasive CVP is performed continuously for intensive care patients until discharge).
Control group
Active

Outcomes
Primary outcome [1] 4717 0
Correlation of central venous pressure measurement by compression sonography with invasive measurement
Timepoint [1] 4717 0
Invasely measured CVP will be recorded at time of measuring CVP by compression sonography, at the end of the data collection phase
Secondary outcome [1] 7965 0
Learning effect by researchers on correlation of measurements by comparing the results from the first half of the patients with the second half.
Timepoint [1] 7965 0
At end of data collection phase.

Eligibility
Key inclusion criteria
Intensive Care patients with central venous catheter
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Thrombosed jugular veins

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
3/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3833 0
Hospital
Name [1] 3833 0
Fremantle Hospital
Country [1] 3833 0
Australia
Primary sponsor type
Hospital
Name
Fremantle Hospital
Address
Alma St
Fremantle
6160
WA
Country
Australia
Secondary sponsor category [1] 3442 0
None
Name [1] 3442 0
Address [1] 3442 0
Country [1] 3442 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5885 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 5885 0
Alma St, Fremantle, Western Australia
Ethics committee country [1] 5885 0
Australia
Date submitted for ethics approval [1] 5885 0
19/08/2008
Approval date [1] 5885 0
29/10/2008
Ethics approval number [1] 5885 0
08/410

Summary
Brief summary
Hypothesis - central venous pressure measurement by compression sonography correlates with central venous pressure measurement by invasive methods
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28907 0
Address 28907 0
Country 28907 0
Phone 28907 0
Fax 28907 0
Email 28907 0
Contact person for public queries
Name 12064 0
Adrian Goudie
Address 12064 0
Fremantle Hospital
Alma St
Fremantle
WA
6160
Country 12064 0
Australia
Phone 12064 0
0894313333
Fax 12064 0
Email 12064 0
[email protected]
Contact person for scientific queries
Name 2992 0
Adrian Goudie
Address 2992 0
Fremantle Hospital
Alma St
Fremantle
WA
6160
Country 2992 0
Australia
Phone 2992 0
0894313333
Fax 2992 0
Email 2992 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.