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Trial registered on ANZCTR

Registration number

ACTRN12615001014549

Ethics application status

Approved

Date submitted

24/07/2015

Date registered

29/09/2015

Date last updated

29/09/2015

Type of registration

Retrospectively registered

Titles & IDs

Public title

A comparison of the force required for removal of intravenous cannulae using two taping methods

Scientific title

A comparison of the force required for removal of intravenous cannulae using the 'under and over' and 'horizontal' taping methods in healthy hospital staff volunteers.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Nil

Trial acronym

Nil

Linked study record

Health condition

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

Intravenous Cannula security

Condition category

Condition code

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Comparison of two commonly utilised techniques for securing intravenous cannulae. Force of dislodgement measured in antergrade and retrograde directions with force transducer and these forces compared.
The "under and over" technique is the intervention arm being compared to the more standard "two horizontal tape" method.
The plastic sheaths of four needle-less intravenous cannulae were secured to the skin surface (not intravenously) using an ‘under and over’ method with one of the tapes applied to the posterior surface of the hub then crossed anteriorly to adhere to the opposite skin surface or ‘horizontal’ taping with the tapes applied horizontally across the anterior surface of the hub. The peak force required to dislodge the taped cannulae using each of these different methods was then measured in both an anterograde and retrograde direction of force using a force transducer.
Each participant had two cannulae for each of the two techniques ie four cannulae in total. The cannulae were applied sequentially to the cubital fossae (2 per arm)of the body. The first cannula was placed in one cubital fossa using the control technique and removed in an anterograde fashion, followed by the second cannula on the same cubital fossa utilising the intervention technique, again dislodged using anterograde force. The process was repeated on the opposite cubital fossa using retrograde force. Cannulae were left in place 5 mins before removal and there was approximately five minutes again until the next cannula removal.
Anterograde / retrograde removal is defined as the hub is pulled in direction of cannula removal (anterograde) and against the direction of removal (retrograde) until dislodged.
A senior clinician grade operator (often PI) applies the force transducer to the cannula hub whilst blinded to the technique utilised.
A second senior clinician grade applies the cannulae without revealing this to the operator attempting removal.
There were no adherence monitoring process applied.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

An intervention "under and over" technique compared with a control "over only "technique

Control group

Active

Outcomes

Primary outcome [1]

Peak force required for removal of cannula from skin using a force transducer in anterograde and retrograde directions.

Timepoint [1]

single measurement each for anterograde-under-and-over, anterograde-horizontal, retrograde-under-and-over and retrograde-horizontal, each five minutes apart (5 minute washout period for skin recovery plus 5 minutes wait after application till removal).

Secondary outcome [1]

Nil

Timepoint [1]

Nil

Eligibility

Key inclusion criteria

Emergency Dept staff volunteers

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Allergy to taping materials; excess forearm hair; excess propensity for sweating; unwillingness to be involved

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

All subjects had force of cannula removal measured with both methods. Randomisation was by central randomisation via PC known to only the operator applying the cannulae

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The second author randomly altered the order of taping for the subjects and recorded them whilst the researcher recorded the results of the trials separately. The results were unmasked on completion of the trial. The researcher was therefore blinded to the taping used to prevent any possible measurement bias in removal of the tapes with the force gauge and the second author blinded to the results in an attempt to limit any bias in the taping.
Only the extreme edge of the cannula hub was visible to the operator applying the force transducer. The rest of the cannula was covered, thus masking the technique applied.
Randomisation was simple randomisation using a randomisation table created by computer software.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Crossover

Other design features

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

The results followed a normal distribution allowing a Students T Test for paired means to be used to compare the two taping styles in both directions of force. These results were analysed utlilsing the statistical package-SPSS-PASW 22.
Power calculation yielded 35 comparisons required to demonstrate a difference of at least 1 standard deviation with a confidence interval of 95% and power of 90%.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

5/07/2011

Actual

20/07/2011

Date of last participant enrolment

Anticipated

21/09/2011

Actual

21/09/2011

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal North Shore Hospital - St Leonards

Recruitment postcode(s) [1]

2065 - Royal North Shore Hospital

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Hospital

Name

Royal North Shore Hospital

Address

Emergency Department
Royal North Shore Hospital
Reserve Road
St Leonards
NSW 2065
Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Local Health District HREC

Ethics committee address [1]

Kolling Building
Royal North Shore Hospital
Pacific Highway
St Leonards NSW 2065
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/09/2010

Approval date [1]

10/12/2010

Ethics approval number [1]

0911-310M (LR)

Summary

Brief summary

A comparison of two commonly used methods for securing intravenous cannulas
	
 
Objective: 
There is a wide variety of techniques to secure intravenous cannulas but little objective evidence to support their relative efficacy. This study compares the security of the two most common methods used within a major Australian Emergency Department. 

Methods:  	
The plastic sheaths of four needle-less intravenous cannulas were secured to the skin surface (not intravenously) of 40 volunteers using two different taping styles, an ‘under and over’ method with one of the tapes applied to the posterior surface of the hub then crossed anteriorly to adhere to the opposite skin surface or ‘horizontal’ taping with the tapes applied horizontally across the anterior surface of the hub. The peak force required to dislodge the taped cannulas using each of these different methods was then measured in both an anterograde and retrograde direction of force using a force transducer.
In more detail,  the force of dislodgement was measured in antergrade and retrograde directions with a force transducer and these forces compared. 
The "under and over" technique was the intervention arm being compared to the more standard "two horizontal tape" method.
The plastic sheaths of four needle-less intravenous cannulae were secured to the skin surface (not intravenously) using an ‘under and over’ method with one of the tapes applied to the posterior surface of the hub then crossed anteriorly to adhere to the opposite skin surface or ‘horizontal’ taping with the tapes applied horizontally across the anterior surface of the hub. The peak force required to dislodge the taped cannulae using each of these different methods was then measured in both an anterograde and retrograde direction of force using a force transducer.
Each participant had two cannulae for each of the two techniques ie four cannulae in total. The cannulae were applied sequentially to the cubital fossae (2 per arm)of the body. The first cannula was placed in one cubital fossa using the control technique and removed in an anterograde fashion, followed by the second cannula on the same cubital fossa utilising the intervention technique, again dislodged using anterograde force. The process was repeated on the opposite cubital fossa using retrograde force. Cannulae were left in place 5 mins before removal and there was approximately five minutes again until the next cannula removal. 
Anterograde / retrograde removal is defined as the hub is  pulled in direction of cannula removal (anterograde) and against the direction of removal (retrograde) until dislodged.
A senior clinician grade operator (often PI) applies the force transducer to the cannula hub whilst blinded to the technique utilised. 
A second senior clinician grade applies the cannulae without revealing this to the operator attempting removal.
There were no adherence monitoring process applied.


Results:    	
The force required to dislodge a cannula taped in an ‘under and over’ taping style was significantly higher than that required for the horizontal taping in both anterograde and retrograde directions of force. (p <0.001)

Conclusion:  	
The results of this study suggest that the ‘under and over’ taping technique offers significantly more security than ‘horizontal’ taping  and should be considered as a more effective method for securing intravenous cannulas.

Trial website

Nil

Trial related presentations / publications

A comparison of two commonly used methods for securing intravenous cannulas
Dr Susan Stace MB BS FACEM
Free Paper Presentation
2013 ACEM Annual Scientific Meeting
Adelaide Convention Centre
North Terrace Adelaide SA Australia
Afternoon Session, 26-11-2013

Public notes

Nil

Attachments [1]

/AnzctrAttachments/368984-Submission_Version5[2].doc

Contacts

Principal investigator

Name

Dr Susan Stace

Address

Emergency Dept
Liverpool Hospital
Corner of Elizabeth and Goulburn Streets
LIVERPOOL NSW 2170
Liverpool NSW

Country

Australia

Phone

+61 419 147 947

Fax

[email protected]

Contact person for public queries

Name

Mark Gillett

Address

Emergency Dept
Royal North Shore Hospital
Reserve Road
St Leonards 2065 NSW

Country

Australia

Phone

+61 457 829 396

Fax

[email protected]

Contact person for scientific queries

Name

Mark Gillett

Address

Emergency Dept
Royal North Shore Hospital
Reserve Road
St Leonards 2065 NSW

Country

Australia

Phone

+ 61 457 829 396

Fax

[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

Source	Title	Year of Publication	DOI
Embase	A comparison of two commonly used methods for securing intravenous cannulas.	2017	https://dx.doi.org/10.6705/j.jacme.2017.0702.003

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically