ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pre operative peripheral venous cannulation

Condition category

Condition code

Anaesthesiology

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]

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]

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]

Direct measurement of number of attempts and time taken (usually within 5 minutes)

Secondary outcome [1]

Time to venous cannulation

Timepoint [1]

As for the Primary time point - time measured with a stopwatch.

Secondary outcome [2]

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]

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?

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)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Adelaide Hospital Research Ethics Committee

Ethics committee address [1]

Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

12/11/2012

Ethics approval number [1]

(Protocol Number 12107)

Summary

Brief summary

Peripheral intravenous cannulation is a commonly performed procedure. The insertion of an intravenous cannula is usually uncomplicated, however it can be difficult in certain patients, including hypovolemic or critically ill patients, IV drug users, patients having repeated courses of chemotherapy, and obese patients. 

Perceived ease and efficiency of cannulation is related to the experience of the cannulator. It has been shown that, when certain manoeuvres are performed, for example, warming the skin prior to insertion of a peripheral venous cannula, both the time taken for insertion and number of attempts required for cannulation are reduced. A randomised controlled trial evaluated ultrasound guided peripheral venous cannulation in patients with a history of difficult intravenous cannulation, however it found no significant difference between the two groups in time to successful cannulation, number of attempts or number of subjects in whom IV cannulation was successful on the first attempt. 

It is common practice for health professionals to tap a vein, prior to cannulation, on the assumption that it will improve the perceived ease of cannulation and therefore the likelihood of successful cannulation. This assumption is based on anecdotal evidence and a rigorous investigation of the effect of tapping of the vein on the time taken and the number of attempts required to cannulate has not been undertaken. 

The optimisation of conditions is important for this commonly performed procedure. Failed attempts at cannulation can lead to fear induced vasoconstriction by activation of the sympathetic nervous system, resulting in subsequent attempts being more difficult. Multiple attempts at cannulation are also unpleasant for the patient.  

We investigated whether or not tapping of a selected vein prior to cannulation improved the perceived ease of cannulation and the success of cannulation.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Lok Yin Evelyn Cheng

Address

Department of Anaesthesia
Royal Adelaide Hospital
North Terrace, Adelaide
South Australia 5000

Country

Australia

Phone

+61402709829

Fax

ev_cheng@hotmail.com

Contact person for public queries

Name

Jonathan Dutt-Gupta

Address

Department of Anaesthesia
Royal Adelaide Hospital
North Terrace, Adelaide
South Australia 5000

Country

Australia

Phone

+61 8 8222 4000

Fax

jondg@me.com

Contact person for scientific queries

Name

Anna Marria Carrera

Address

Department of Anaesthesia
Royal Adelaide Hospital
North Terrace, Adelaide
South Australia 5000

Country

Australia

Phone

+61 8 8222 5858

Fax

AnnaMaria.Carrera@health.sa.gov.au

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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