Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000993291
Ethics application status
Not yet submitted
Date submitted
16/11/2009
Date registered
17/11/2009
Date last updated
17/11/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of external rotation of the leg on the size and accesssibility of the femoral vein
Scientific title
The effect of external rotation of the leg versus a neutral leg position on femoral vein diameter and degree of overlap by the femoral artery in stable patients presenting to the Emergency Department (ED).
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Examination of effect of leg position on accessibility of femoral vein for femoral venous access 252215 0
Condition category
Condition code
Anaesthesiology 252401 252401 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
For each patient, the femoral vessels will be visualised using a vascular ultrasound probe with the leg in the neutral position and then with the leg externally rotated. Measurements will be made only once with the leg in each of these positions. This procedure will take approximately 10 minutes
Intervention code [1] 241558 0
Not applicable
Comparator / control treatment
neutral vs externally rotated leg
Control group
Active

Outcomes
Primary outcome [1] 253277 0
Diameter of femoral vein in each position.
Measurements will be made in real time. That is, the size and overlap over the vessels will be measured as soon as the leg has been placed in the selected position. The process of obtaining the ultrasound image takes 1-2 minutes but once the image is obtained, the measurements are made immediately on the frozen image.
Timepoint [1] 253277 0
Immediately upon obtaining a clear image of the femoral vein and artery
Secondary outcome [1] 262273 0
Proportion of overlap by femoral artery in each leg position. Both a) the total diameter of the vein and b) the diameter of the vein lying medial to the artery (ie not overlapped by the femoral artery) are measured in millimetres. The proportion of overlap is 1- (b/a).
Timepoint [1] 262273 0
Immediate - as above, the measurement is taken as soon as a clear image is obtained.

Eligibility
Key inclusion criteria
Stable patients presenting to the ED who are triaged to a bed as part of their usual care.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Previous femoral vascular surgery or cannulation
Critically unwell (altered level of consciousness, pulse rate greater than 120 beats per minute of systolic blood pressure less than 90mmHg

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 244023 0
Self funded/Unfunded
Name [1] 244023 0
Country [1] 244023 0
Primary sponsor type
Individual
Name
Anna Holdgate
Address
Emergency Department
Liverpool Hospital
Elizabeth St
Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 251372 0
None
Name [1] 251372 0
Address [1] 251372 0
Country [1] 251372 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258130 0
SouthWest Sydney Area Health Service Ethics committee (western zone)
Ethics committee address [1] 258130 0
Liverpool Hospital
Locked Bag 7103
Liverpool BC
NSW 1871
Ethics committee country [1] 258130 0
Australia
Date submitted for ethics approval [1] 258130 0
10/01/2010
Approval date [1] 258130 0
Ethics approval number [1] 258130 0

Summary
Brief summary
Observational study examining changes in femoral vessel relationship and size in two different leg positions
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30514 0
Address 30514 0
Country 30514 0
Phone 30514 0
Fax 30514 0
Email 30514 0
Contact person for public queries
Name 13761 0
Anna Holdgate
Address 13761 0
Emergency Department
Liverpool Hospital
Locked Bag 7103
Liverpool BC
NSW 1871
Country 13761 0
Australia
Phone 13761 0
+61 2 98283693
Fax 13761 0
Email 13761 0
[email protected]
Contact person for scientific queries
Name 4689 0
anna holdgate
Address 4689 0
Emergency Department
Liverpool Hospital
Locked Bag 7103
Liverpool BC
NSW 1871
Country 4689 0
Australia
Phone 4689 0
+61 2 98283693
Fax 4689 0
Email 4689 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.