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Trial registered on ANZCTR


Registration number
ACTRN12615000408583
Ethics application status
Approved
Date submitted
30/03/2015
Date registered
30/04/2015
Date last updated
22/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Flushing in Peripheral intravenous catheters (FliP): A pilot factorial, randomized trial of high versus low frequency and volume in paediatrics. (‘FliP in Kids’).
Scientific title
To assess the effectiveness of high frequency flushing and volume versus low frequency flushing and volume on device failure in paediatric patients with a peripheral venous catheter. (‘FliP in Kids’).
Secondary ID [1] 286445 0
Nil
Universal Trial Number (UTN)
Trial acronym
FliP in Kids
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral cannula maintenance 294617 0
Condition category
Condition code
Public Health 294919 294919 0 0
Health service research
Infection 294920 294920 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will have their peripheral cannula (PIVC) flushed with one of the following, until the patient requires PIVC removal, by the nurse providing care for the patient:

1. low frequency IV flush 0.9% Sodium Chloride every 24h, low volume 3mL
2. low frequency IV flush 0.9% Sodium Chloride every 24h , high volume 10mL
3. high frequency IV flush 0.9% Sodium Chloride every 6h, low volume 3mL
4. high frequency IV flush 0.9% Sodium Chloride every 6h, high volume 10mL
AND
pre and post medication administration.
Intervention code [1] 291522 0
Prevention
Intervention code [2] 291523 0
Treatment: Devices
Comparator / control treatment
The high frequency arm. Standard frequency of PIVC flushes (and therefore control/comparator) was Q6h (i.e. 4 times a day). Volume varied.
Control group
Active

Outcomes
Primary outcome [1] 294671 0
Feasibility of definitive factorial RCT: composite analysis of feasibility criteria:
Eligibility: greater than or equal to 70% of patients screened will be eligible
Recruitment: greater than or equal to 80% of patients eligible agree to enroll
Retention: less than or equal to 10% of patients are lost to follow up or withdraw
Protocol adherence: greater than or equal to 90% of patients receive their allocated treatment
Missing data: less than or equal to 10% data are missed
Sample size estimates: Estimates of proportion of PIVC device failure associated with each treatment.
Timepoint [1] 294671 0
12 months post study commencement
Secondary outcome [1] 313845 0
PIVC failure defined by a composite analysis of occlusion, infiltration, dislodgment or phlebitis defined as follows and in keeping with normal clinical assessment: occlusion (thrombotic or non-thrombotic, partial or complete); infiltration (leaking of fluid/infusate in to surrounding tissue); dislodgment (partial or total from insertion site); phlebitits (pain or tenderness on scale of 0 no pain – 10 acute, and/or erythema or swelling at the site measured in centimentres, and/or palpable cord or vein streak yes.mo, <7,5cm, >7.5cm).
Timepoint [1] 313845 0
While PIVC insitu or within 48 hours of PIVC removal
Secondary outcome [2] 313846 0
Individual reasons for failure in keeping with normal clinical assessment documented in notes and further collected on trial daily check form: occlusion (thrombotic or non-thrombotic, partial or complete); infiltration (leaking of fluid/infusate in to surrounding tissue); dislodgment (partial or total from insertion site); phlebitits (pain or tenderness on scale of 0 no pain – 10 acute, and/or erythema or swelling at the site measured in centimentres, and/or palpable cord or vein streak yes.mo, <7,5cm, >7.5cm).
Timepoint [2] 313846 0
Following removal of PIVC
Secondary outcome [3] 313847 0
Phlebitis
Timepoint [3] 313847 0
Phlebitis scores will be collected daily while PIVC is insitu and on removal of PIVC.

Phlebitis indicators will be measured as follows:

Pain from site: (no pain) 0…..1…..2…..3…..4…..5…..6…..7…..8…..9…..10 (acute pain)

Tenderness: (no tenderness) 0…..1…..2…..3…..4…..5…..6…..7…..8…..9…..10 (acute tenderness)

Erythema: should be measured from entry point with a ruler and scored:
None, <1cm, >1cm but <2.5cm, >2.5cm but <5cm, >5cm

Swelling: should be measured from entry point with a ruler and scored:
None , <1cm, >1cm but <2.5cm, >2.5cm but <5cm, >5cm

Palpable Cord or Vein Streak: Yes/No
Less than 7.5cm, greater than 7.5cm
Secondary outcome [4] 313848 0
Dislodgement
Timepoint [4] 313848 0
Data will be collected at the daily check when PIVC has been documented as dislodged
Secondary outcome [5] 313849 0
Cost

Cost will be calculated based on the days each PIVC was insitu (per 1000 catheter days)
Timepoint [5] 313849 0
Cost will be calculated at the completion of the trial
Secondary outcome [6] 313850 0
Mortality
Timepoint [6] 313850 0
Rate of mortality will be assessed on completion of the trial
Secondary outcome [7] 341567 0
Laboratory confirmed bloodstream infection, Electronic pathology results will be checked up to 48 hours after PIVC removal.
Timepoint [7] 341567 0
During PIVC dwell time and within 48 hours of removal
Secondary outcome [8] 341568 0
PIVC dwell time in days and hours calculated from time and day of insertion and time and day of elective removal or failure and subsequent removal
Timepoint [8] 341568 0
at time of removal

Eligibility
Key inclusion criteria
Peripheral intravenous catheter inserted for clinical care

Informed consent to participate
Minimum age
No limit
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients < 5kg or on fluid restrictions

Planned removal of Peripheral intravenous catheter within next 24hrs

Previous enrolment in the current study

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)
Computer generated allocation. Allocation is concealed until participant is randomised via a computerised randomisation service once consent has been given.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3619 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 9402 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 291013 0
University
Name [1] 291013 0
Griffith University
Address [1] 291013 0
Nathan Campus
170 Kessels Road
Nathan
Queensland, 4111
Country [1] 291013 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus
170 Kessels Road
Nathan
Queensland, 4111
Country
Australia
Secondary sponsor category [1] 289689 0
None
Name [1] 289689 0
Address [1] 289689 0
Country [1] 289689 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292597 0
Children's Health Queensland
Ethics committee address [1] 292597 0
501 Stanley Street,
South Brisbane,
Qld 4101
Ethics committee country [1] 292597 0
Australia
Date submitted for ethics approval [1] 292597 0
Approval date [1] 292597 0
19/08/2014
Ethics approval number [1] 292597 0
HREC/14/QRCH/233

Summary
Brief summary
Venous cannulation via peripheral intravenous catheters (PIVC) is the simplest and most frequently used method for drug, fluid and blood product administration. Researchers estimate that up to 70% of patients in acute care hospitals require a PIVC. However, PIVC are associated with inherent complications which can be mechanical or infectious. Failure rates of these devices is unacceptably high, affecting up to 40% of patients receiving this therapy.

Of these, 30% failed due to occlusion and infiltration (fluids into surrounding tissues) meaning patients had to have the PIVC replaced, which has implications for patient comfort, therapy and health care costs.There have been a range of strategies developed to prevent or reduce PIVC related complications including flushing regimes to maintain PIVC patency. However, current flushing practice is widely varied, with poor outcomes. There is little evidence that flushing of PIVC is actually happening in practice. To achieve best and evidence based practice it imperative that trial research is conducted to establish the best regime for maintaining PIVC patency.

The study aims to establish the feasibility of conducting a four arm, factorial, randomized trial evaluating the efficacy and cost effectiveness of different flushing frequencies and volumes in a paediatric population.
Trial website
Trial related presentations / publications
None to date (manuscript in progress)
Public notes

Contacts
Principal investigator
Name 54390 0
Prof Samantha Keogh
Address 54390 0
Queensland University of Technology, School of Nursing, N Block, Victoria Park Road, Kelvin Grove, Brisbane Qld 4059
Country 54390 0
Australia
Phone 54390 0
+61 7 31383881
Fax 54390 0
Email 54390 0
s2.keogh@qut.edu.au
Contact person for public queries
Name 54391 0
Ms Julie Flynn
Address 54391 0
Centre for Clinical Nursing Level 2, Building 34 RBWH Butterfield Street Herston Queensland 4029
Country 54391 0
Australia
Phone 54391 0
+61 7 36468293
Fax 54391 0
Email 54391 0
julie.flynn@griffith.edu.au
Contact person for scientific queries
Name 54392 0
Prof Samantha Keogh
Address 54392 0
Queensland University of Technology, School of Nursing, N Block Victoria Park Road, Kelvin Grove, Brisbane Qld 4059
Country 54392 0
Australia
Phone 54392 0
+61 731383881
Fax 54392 0
Email 54392 0
s2.keogh@qut.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary