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Trial registered on ANZCTR


Registration number
ACTRN12616001683426
Ethics application status
Approved
Date submitted
1/12/2016
Date registered
7/12/2016
Date last updated
7/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Correlation of peripheral venous collapse with central venous pressure as a non-invasive bedside clinical sign
Scientific title
Correlation of peripheral venous collapse with invasively monitored central venous pressure. A single centre prospective observational study
Secondary ID [1] 290667 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Correlation between peripheral venous collapse and central venous pressure 301199 0
Condition category
Condition code
Cardiovascular 300955 300955 0 0
Normal development and function of the cardiovascular system
Cardiovascular 300975 300975 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The height of peripheral venous collapse will be compared with the invasively monitored central venous pressure in a cohort of spontaneously breathing intensive care patients.
This study will be performed on patients in intensive care with a central venous catheter already in place as part of their treatment. After the participant has provided consent, the head of the bed will be positioned at a slight angle (45 degrees), and the participant assisted to slowly raise their arm above the level of their chest. The height of peripheral venous collapse will be observed by observing the veins on the back of the hand as the arm rises, and the height at which the veins collapse will be recorded. At the same time, the pressure reading via the central venous catheter that is constantly displayed on the monitor will be noted by a separate observer. A single assessment will be performed; the total time required should be no more than 5-10 minutes.
Intervention code [1] 296549 0
Not applicable
Comparator / control treatment
No control group. Recording of both peripheral venous collapse and central venous pressure will occur in all patients. The invasively monitored central venous pressure will serve as the comparator to peripheral venous collapse (outcome under investigation).
Control group
Active

Outcomes
Primary outcome [1] 300376 0
Correlation between height of peripheral venous collapse with central venous pressure). The aim of the study is to describe the relationship between peripheral venous collapse and central venous pressure. Therefore if the two measurements are found to be closely correlated this relationship will be described using appropriate statistics (depending on the observed relationship).
Timepoint [1] 300376 0
At time of assessment
Secondary outcome [1] 329822 0
None
Timepoint [1] 329822 0
N/A

Eligibility
Key inclusion criteria
* ICU patients
* Age greater than or equal to 18 years
* Able to provide consent
* Visible vein on the dorsal aspect of the hand
* Current central venous pressure monitoring via central venous catheter
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Management with vasoactive infusions
* Invasive or non-invasive mechanical ventilation
* Medical contraindication to arm-raising
* Deemed unsuitable by treating intensive care unit doctor

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The relationship between height of peripheral venous collapse and central venous pressure will be graphically checked for linearity and transformed if necessary. Although Pearson correlations, and linear regression models, will be obtained for purposes of comparison with other studies, peripheral venous collapse and central venous pressure agreement will be more directly assessed using methods such as Bland-Altman plots and intraclass correlations. 95% confidence intervals will be reported throughout.

Statistical analyses will be undertaken by, or under the direction of, Epworth HealthCare biostatistician(s), using standard statistical software such as Stata (Stata Corporation, College Station, Texas, 2015).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/12/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
86
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7047 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 14775 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 295098 0
Hospital
Name [1] 295098 0
Epworth Healthcare
Country [1] 295098 0
Australia
Primary sponsor type
Hospital
Name
Epworth Healthcare
Address
Epworth Hospital
89 Bridge Road,
Richmond VIC 3121
Country
Australia
Secondary sponsor category [1] 293916 0
None
Name [1] 293916 0
Address [1] 293916 0
Country [1] 293916 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296449 0
Epworth HealthCare Human Research Ethics Committee
Ethics committee address [1] 296449 0
Ground Floor, Pelaco Building
21-31 Goodwood Street
Richmond Vic 3121
Ethics committee country [1] 296449 0
Australia
Date submitted for ethics approval [1] 296449 0
01/08/2016
Approval date [1] 296449 0
22/09/2016
Ethics approval number [1] 296449 0
EH2016-116

Summary
Brief summary
The purpose of this study is to determine whether there is a correlation between the height at which the veins on the back of the hand collapse, and the pressure measured by a central venous catheter in the heart (central venous pressure).The central venous pressure is used to guide how much fluid should be given to a patient, but is currently only available using invasive procedures performed in special departments within hospitals, such as intensive care. It would therefore be very helpful to be able to obtain this pressure using a non-invasive technique that could be used anywhere.

This study will be performed on patients in intensive care with a central venous catheter already in place as part of their treatment. After the participant has provided consent, the head of the bed will be positioned at a slight angle (45 degrees), and the participant assisted to slowly raise their arm above the level of their chest. The veins on the back of the hand will be observed as the arm rises, and the height at which the veins collapse will be recorded. At the same time, the pressure reading via the central venous catheter that is constantly displayed on the monitor will be noted. The total time required should not be more than 15 minutes.

A biostatistician will then analyse the readings to determine if there is correlation between the two measurements in each participant.

There are no additional risks to participants in this study. All the risks associated with this study are related to use of the central venous catheter, which will already be present as part of their standard care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70898 0
Miss Tina Zhou
Address 70898 0
Intensive Care Unit,
Epworth Hospital,
89 Bridge Road,
Richmond VIC 3121
Country 70898 0
Australia
Phone 70898 0
+61 03 9329 1380
Fax 70898 0
Email 70898 0
[email protected]
Contact person for public queries
Name 70899 0
Tina Zhou
Address 70899 0
Intensive Care Unit,
Epworth Hospital,
89 Bridge Road,
Richmond VIC 3121
Country 70899 0
Australia
Phone 70899 0
+61 03 9329 1380
Fax 70899 0
Email 70899 0
[email protected]
Contact person for scientific queries
Name 70900 0
Jonathan Barrett
Address 70900 0
Intensive Care Unit,
Epworth Hospital,
89 Bridge Road,
Richmond VIC 3121
Country 70900 0
Australia
Phone 70900 0
+61, 03, 9426 6666
Fax 70900 0
Email 70900 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

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