Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000471785
Ethics application status
Approved
Date submitted
16/04/2013
Date registered
26/04/2013
Date last updated
29/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised control trial to determine whether “tapping” on a vein improves perceived ease of venous cannulation, and rate of successful cannulation in patients undergoing elective surgery.
Scientific title
A randomised control trial to determine whether “tapping” on a vein improves perceived ease of venous cannulation, and rate of successful cannulation in patients undergoing elective surgery.
Secondary ID [1] 282352 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre operative peripheral venous cannulation 288916 0
Condition category
Condition code
Anaesthesiology 289262 289262 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Peripheral venous cannulation by an experienced anaesthetic registrar prior to admission to theatre/surgery. This will be timed and recorded as successful or unsuccessful by the assistant. The registrar is blinded to the intervention.

The assistant lightly taps on the dorsum of the patient's hand, over the previously rated vein (by anaesthetic registrar) for 20 seconds. This occurs only once prior to reassessment of the vein and cannulation by the anaesthetic registrar.
Intervention code [1] 286975 0
Other interventions
Comparator / control treatment
Assistant to tap on her own hand instead of patient's chosen vein for the control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 289367 0
The primary outcome to be evaluated will be whether or not the treatment (tapping) reduces the number of attempts to cannulate a patient undergoing elective surgery.
Timepoint [1] 289367 0
Direct measurement of number of attempts and time taken (usually within 5 minutes)
Secondary outcome [1] 302332 0
Time to venous cannulation
Timepoint [1] 302332 0
As for the Primary time point - time measured with a stopwatch.
Secondary outcome [2] 302377 0
Improvement of perceived ease of cannulation is rated immediately in front of the patient once the intervention (tapping/no tapping) has occured. The vein is rated prior to cannulation and then compared to the rating after the intervention.

This was rated using the prevalidated scale by:

Lenhardt R, Seybold T, Kimberger O, Stoiser B, Sessler D. Local warming and insertion of peripheral venous cannulation: single blinded prospective randomised controlled trial BMJ: 2002; volume 325 pp 409

The details of the scale used:

Veins were classified as
(1) clearly visible and easily palpable
(2) veins visible and palpable
(3) veins barely visible and palpable,
(4) veins viable but not palpable
(5) veins neither visible or palpable
Timepoint [2] 302377 0
Using the prevalidated scale above, assessment occurs before and after each intervention/no intervention (in front of the patient).

Eligibility
Key inclusion criteria
Inclusion criteria –
All patients admitted to Day of Surgery Admission Unit (DOSA) for same-day elective surgery who require a venous cannula.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria –
Patients will be excluded if they are premedicated, unable to communicate in English, intellectually impaired, age<18 yr or recently ingested analgesic medication

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a prospective, randomized, single blinded study to be conducted in Day of Admissions Unit (DOSA) at the Royal Adelaide Hospital.

Admission of patients will be as per normal DOSA procedure. Informed consent will be obtained from patients awaiting same-day elective surgery who require a venous cannula.

Patients will be randomised into two groups, tapping (group T) and non-tapping (group NT) using pre-arranged random number generator, independent of the two study investigators.

Allocation is concealed by sealed opaque envelopes, only opened 10s prior to patient intervention by the assistant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Method used for allocation to intervention in this randomised controlled trial is simple randomisation using a computerised sequence generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As no pilot study was conducted, the sample size was calculated based on previous similar studies attempting to identify differences in interventions for ease of peripheral cannulation. [previously referenced Ledhart paper] We calculated that a total of 120 subjects were required to detect a 20% difference in mean time to perform a cannulation between the groups with a power of 0.80 and a type 1 error rate of 0.05 .
Our initial aim was to recruit 120 patients, however due to time and resource constraints, we limited our recruitment to 100 participants.


Intention to treat analysis to occur.

For the primary outcome of ‘successful cannulation on first attempt’, a logistic regression model was used to explore the association between randomization group and whether first attempt cannulation was successful.

For the secondary outcome of ‘time to successful cannulation’ a linear regression model was used.

For the secondary outcome of ‘improvement of perceived ease of cannulation’,
a Wilcoxon signed rank sum test was performed to analyse the difference between paired rankings across the two groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/01/2013
Actual
18/01/2013
Date of last participant enrolment
Anticipated
5/02/2013
Actual
5/02/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 898 0
The Royal Adelaide Hospital - Adelaide

Funding & Sponsors
Funding source category [1] 287120 0
Self funded/Unfunded
Name [1] 287120 0
Country [1] 287120 0
Primary sponsor type
Individual
Name
Lok Yin Evelyn Cheng
Address
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Australia
Country
Australia
Secondary sponsor category [1] 285890 0
None
Name [1] 285890 0
Address [1] 285890 0
Country [1] 285890 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289123 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 289123 0
Ethics committee country [1] 289123 0
Australia
Date submitted for ethics approval [1] 289123 0
Approval date [1] 289123 0
12/11/2012
Ethics approval number [1] 289123 0
(Protocol Number 12107)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39354 0
Dr Lok Yin Evelyn Cheng
Address 39354 0
Department of Anaesthesia
Royal Adelaide Hospital
North Terrace, Adelaide
South Australia 5000
Country 39354 0
Australia
Phone 39354 0
+61402709829
Fax 39354 0
Email 39354 0
[email protected]
Contact person for public queries
Name 39355 0
Jonathan Dutt-Gupta
Address 39355 0
Department of Anaesthesia
Royal Adelaide Hospital
North Terrace, Adelaide
South Australia 5000
Country 39355 0
Australia
Phone 39355 0
+61 8 8222 4000
Fax 39355 0
Email 39355 0
[email protected]
Contact person for scientific queries
Name 39356 0
Anna Marria Carrera
Address 39356 0
Department of Anaesthesia
Royal Adelaide Hospital
North Terrace, Adelaide
South Australia 5000
Country 39356 0
Australia
Phone 39356 0
+61 8 8222 5858
Fax 39356 0
Email 39356 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.