Trial Review

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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] 287144 0
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 295694 0
Condition category
Condition code
Anaesthesiology 296169 296169 0 0
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] 292409 0
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] 295651 0
Peak force required for removal of cannula from skin using a force transducer in anterograde and retrograde directions.
Timepoint [1] 295651 0
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] 316110 0
Nil
Timepoint [1] 316110 0
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
35
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4092 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 10022 0
2065 - Royal North Shore Hospital

Funding & Sponsors
Funding source category [1] 291839 0
Self funded/Unfunded
Name [1] 291839 0
Country [1] 291839 0
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] 290507 0
None
Name [1] 290507 0
Address [1] 290507 0
Country [1] 290507 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293232 0
Northern Sydney Local Health District HREC
Ethics committee address [1] 293232 0
Ethics committee country [1] 293232 0
Australia
Date submitted for ethics approval [1] 293232 0
16/09/2010
Approval date [1] 293232 0
10/12/2010
Ethics approval number [1] 293232 0
0911-310M (LR)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 529 529 0 0
/AnzctrAttachments/368984-Submission_Version5[2].doc

Contacts
Principal investigator
Name 58994 0
Dr Susan Stace
Address 58994 0
Emergency Dept
Liverpool Hospital
Corner of Elizabeth and Goulburn Streets
LIVERPOOL NSW 2170
Liverpool NSW
Country 58994 0
Australia
Phone 58994 0
+61 419 147 947
Fax 58994 0
Email 58994 0
[email protected]
Contact person for public queries
Name 58995 0
Mark Gillett
Address 58995 0
Emergency Dept
Royal North Shore Hospital
Reserve Road
St Leonards 2065 NSW
Country 58995 0
Australia
Phone 58995 0
+61 457 829 396
Fax 58995 0
Email 58995 0
[email protected]
Contact person for scientific queries
Name 58996 0
Mark Gillett
Address 58996 0
Emergency Dept
Royal North Shore Hospital
Reserve Road
St Leonards 2065 NSW
Country 58996 0
Australia
Phone 58996 0
+ 61 457 829 396
Fax 58996 0
Email 58996 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
SourceTitleYear of PublicationDOI
EmbaseA comparison of two commonly used methods for securing intravenous cannulas.2017https://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.