Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001212842
Ethics application status
Approved
Date submitted
14/11/2012
Date registered
15/11/2012
Date last updated
16/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Intravenous Lines-Glue Or Not Experiment
Scientific title
Intravenous Lines-Glue Or Not Experiment (IVL-GONE): the use of skin glue plus standard dressing to secure an IVL to reduce the rate of failure in patients admitted to hospital.
Secondary ID [1] 280360 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
IVL-GONE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reducing the rate of IVL failure as a result of
Infection, Phlebitis, Occlusion and/or Dislodgement (IPOD) by using skin glue plus a standard dressing to secure IVL. 286332 0
Condition category
Condition code
Infection 286578 286578 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will involve patients in the Emergency Department who already have an IVL insitu secured by a standard dressing and are admitted and awaiting a bed on the wards within the hospital.
The research team will identify and consent these patients if they are otherwise eligible and fit the inclusion criteria.
If a patient is randomised to receive skin glue then their original dressing will be removed, glue applied to the IVL and allowed to dry (mater of minutes) before a new standard dressing is applied back over the top of the IVL. The skin glue applied is single use therefore one per patient used once only.
If they are randomised to the control group then they will simply have their current standard dressing removed and replaced with another standard dressing.
The research team will look at failure (IPOD) of the first IVL inserted in the patient by following the patient up either within the hospital or by telephoning them 48hrs after application of the dressing they have been randomised too.
Those patients randomised to the intervention group will receive skin glue plus standard dressing to secure the IVL.
Intervention code [1] 284727 0
Treatment: Other
Intervention code [2] 286051 0
Prevention
Comparator / control treatment
Use of a standard dressing used in standard practice to secure an intravenous line.
Control group
Active

Outcomes
Primary outcome [1] 287000 0
To reduce the failure rate of IVLs inserted in patients by reducing the combined poor outcomes of Infection, Phlebitis, Occlusion and Dislodgement (IPOD).
Failure rate of the study IVL is defined by one or more of IPOD occuring.
-Infection is defined by cellulitis at the IVL insertion site.
-Phlebitis is defined by two or more of these symptoms; pain, redness, swelling or a palpable venous cord.
-Occlusion is defined by when 5ml of 0.9% saline can not be easily 'flushed' through or when the IVL has been removed due to clinical staff stating the IVL 'was not working'.
-Dislodgement is defined by either evidence of subcutaneous extravasation or IVL no longer present at the insertion site.
Failure of the first IVL inserted in the patient as a result of IPOD will be assessed and decided upon by the researcher who is also a health clinician. The researcher will look for and/or ask about IPOD associated clinical signs and symptoms when they follow the patient up at 48hrs either in person on the wards or by telephone.
Timepoint [1] 287000 0
Patients enrolled in the trial will be followed up once only. This will be at 48hrs after they have had their IVL dressing changed for the purposes of being part of the trial.
They will be followed up by the researchers either in person on the wards within the hospital or by telephone. This is regardless of whether they have been randomised to have skin glue plus standard dressing or standard dressing only.
Secondary outcome [1] 299944 0
Nil
Timepoint [1] 299944 0
Nil

Eligibility
Key inclusion criteria
-Informed written consent by patient or legal decision maker
-Presence of either a pre-hospital (Queensland Ambulance Service) inserted upper limb IVL or clinical indication for an Emergency Department inserted upper limb IVL.
-Decision by Emergency Department staff that patient is to be admitted to hospital therefore IVL expected to be in place greater than 24 hours.
-Patient aged 18years or over.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If the patient is considered to be or have any of the following then they will be excluded from the study.
-Is less than 18 years of age.
-History of allergy or irritation to either standard IVL. insertion materials or skin glue.
-IVL inserted through non-intact (eg area of abrasion or blistering) or diaphoretic skin (too sweaty to enable dressing adhesion).
-Pre-existing upper limb phlebitis, infection, venous thrombosis.
-Agitated patients wo are likely to pull IVL out.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
-Those patients who have an IVL and who are to be admitted to hospital and are waiting to be transferred from the Emergency Department to the ward will be identified.
-From this group only those that match the inclusion criteria for selection and do not match the exclusion criteria for selection will be approached by the research team.
-These patients will be given an explanation of the study first before voluntary written consent is obtained.
-Patients who provide consent will be randomised to either the use of skin glue plus a standard dressing or standard dressing only.
-The researcher who determines if a patient is eligible for inclusion in the study is unaware when the patient is consented whether or not they will receive skin glue plus a standard dressing to secure their IVL or just a standard dressing to secure their IVL. The patient will be randomised using an approved randomisation app on the research iPAD.
-Patients current dressing will be removed and replaced depending on the group the patient is randomised too.
-Patients details will then be entered electronically onto a data sheet application available on the iPad.
-The patient will then be followed up in person on the wards within the hospital or by phone within 48hrs of the dressing change.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation application will be available to use on the research iPad allowing for computerised sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
668
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285137 0
Charities/Societies/Foundations
Name [1] 285137 0
Queensland Emergency Medicine Foundation
Country [1] 285137 0
Australia
Primary sponsor type
Individual
Name
Dr. Simon Bugden
Address
McKean St,
Caboolture Emergency Department,
Caboolture Hospital,
Caboolture,
Qld, 4512
Country
Australia
Secondary sponsor category [1] 285127 0
None
Name [1] 285127 0
Address [1] 285127 0
Country [1] 285127 0
Other collaborator category [1] 260757 0
Individual
Name [1] 260757 0
Professor John Fraser-Critical Care Research Group Director and Intensive Care Staff Specialist at The Prince Charles Hospital
Address [1] 260757 0
627 Rode Road,
Chermside,
Qld, 4032
Country [1] 260757 0
Australia
Other collaborator category [2] 277176 0
Individual
Name [2] 277176 0
Professor Claire Rickard-RCCCPI and NHMRC Centre of Research Excellence in Nursing Interventions for Hospital Patients at Griffith Health Institute and School of Nursing and Midwifery at Griffith University
Address [2] 277176 0
58 Parklands Drive,
Southport,
Qld, 4215
Country [2] 277176 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288354 0
The Prince Charles Hospital HREC
Ethics committee address [1] 288354 0
Ethics committee country [1] 288354 0
Australia
Date submitted for ethics approval [1] 288354 0
26/06/2012
Approval date [1] 288354 0
30/06/2012
Ethics approval number [1] 288354 0
EC00168

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

Contacts
Principal investigator
Name 34090 0
Address 34090 0
Country 34090 0
Phone 34090 0
Fax 34090 0
Email 34090 0
Contact person for public queries
Name 17337 0
Simon Bugden
Address 17337 0
Caboolture Emergency Department,
Caboolture Hospital
McKean St,
Caboolture,
Qld, 4510
Country 17337 0
Australia
Phone 17337 0
+61 7 5433 8973
Fax 17337 0
+61 7 5433 8988
Email 17337 0
Simon_Bugden@health.qld.gov.au
Contact person for scientific queries
Name 8265 0
Simon Bugden
Address 8265 0
Caboolture Emergency Department,
Caboolture Hospital,
McKean St,
Caboolture,
Qld, 4510
Country 8265 0
Australia
Phone 8265 0
+61 7 5433 8973
Fax 8265 0
+61 7 5433 8988
Email 8265 0
Simon_Bugden@health.qld.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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSkin Glue Reduces the Failure Rate of Emergency Department-Inserted Peripheral Intravenous Catheters: A Randomized Controlled Trial.2016https://dx.doi.org/10.1016/j.annemergmed.2015.11.026
N.B. These documents automatically identified may not have been verified by the study sponsor.