Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000025538
Ethics application status
Approved
Date submitted
9/12/2014
Date registered
19/01/2015
Date last updated
14/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Flushing in Peripheral intravenous catheters (FliP):
A pilot, randomised controlled trial of high versus low frequencies and volumes in patients with a peripheral venous catheter.
Scientific title
To assess the effectiveness of high frequency flushing versus low flushing frequency and volume on device failure in patients with a peripheral venous catheter: The FliP pilot trial
Secondary ID [1] 283172 0
Nil
Universal Trial Number (UTN)
Trial acronym
FliP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral cannula maintenance 291116 0
Condition category
Condition code
Infection 291458 291458 0 0
Studies of infection and infectious agents
Public Health 294068 294068 0 0
Health service research

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) Flushed every 6 hours with 3 ml Sodium Chloride 0.9%
2) Flushed every 24 hours with 10 ml Sodium Chloride 0.9%
3) Flushed every 24 hours with 3 ml Sodium Chloride 0.9%
AND
pre and post medication administration.
Intervention code [1] 288752 0
Prevention
Intervention code [2] 290831 0
Treatment: Devices
Comparator / control treatment
Participants in this pilot study will have their peripheral cannula (PIVC) flush every 6 hours with 10 ml Sodium Chloride 0.9% AND pre and post medication administration, until the patient requires PIVC removal, by the nurse providing care for the patient.
Control group
Active

Outcomes
Primary outcome [1] 291439 0
Device failure (due to occlusion and/or infiltration).

PIVC occlusions may be thrombotic or nonthrombotic and may be partial or total in nature. Infiltration is when the IV fluid or drug enters the surrounding tissues rather than vein. PIVC patency is assessed by clinical nurses each shift in line with normal practice and will be documented on a data collection chart generated specifically for the study.
Timepoint [1] 291439 0
While PIVC is insitu.
Secondary outcome [1] 306774 0
Laboratory confirmed bloodstream infection.

Electronic pathology results will be check 48 hours after PIVC has been removed.
Timepoint [1] 306774 0
While PIVC insitu or within 48 hours of PIVC removal
Secondary outcome [2] 312123 0
Dwell time - will be calculated from the insertion date and removal date fields
Timepoint [2] 312123 0
Following removal of PIVC
Secondary outcome [3] 312124 0
Phlebitis
Timepoint [3] 312124 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] 312125 0
Dislodgement
Timepoint [4] 312125 0
Data will be collected at the daily check when PIVC has been documented as dislodged
Secondary outcome [5] 312126 0
Cost

Cost will be calculated based on the days each PIVC was insitu (per 1000 catheter days)
Timepoint [5] 312126 0
Cost will be calculated at the completion of the trial
Secondary outcome [6] 312127 0
Mortality
Timepoint [6] 312127 0
Rate of mortality will be assessed on completion of the trial

Eligibility
Key inclusion criteria
Patients greater than or equal to 16 years of age
PIVC to be inserted for clinical care
Informed consent to participate
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Planned removal of PIVC 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
3/03/2014
Actual
28/04/2014
Date of last participant enrolment
Anticipated
31/08/2014
Actual
28/08/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2060 0
Royal Brisbane & Womens Hospital - Herston

Funding & Sponsors
Funding source category [1] 288685 0
University
Name [1] 288685 0
Griffith University
Country [1] 288685 0
Australia
Funding source category [2] 288686 0
Hospital
Name [2] 288686 0
Royal Brisbane & Women's Hospital
Country [2] 288686 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus
170 Kessels Road
Nathan
Queensland, 4111
Country
Australia
Secondary sponsor category [1] 287394 0
None
Name [1] 287394 0
Address [1] 287394 0
Country [1] 287394 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290532 0
Royal Brisbane & Womens Hospital
Ethics committee address [1] 290532 0
Butterfield Street
Herston
Queensland 4029
Ethics committee country [1] 290532 0
Australia
Date submitted for ethics approval [1] 290532 0
10/12/2013
Approval date [1] 290532 0
27/01/2014
Ethics approval number [1] 290532 0
HREC/13/QRBW/420

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42774 0
Dr Samantha Keogh
Address 42774 0
Griffith University
Nathan Campus
Bldg N48 Rm 0.07
170 Kessels Road
Brisbane
Queensland 4111
Country 42774 0
Australia
Phone 42774 0
+ 61 7 36464121
Fax 42774 0
Email 42774 0
s.keogh@griffith.edu.au
Contact person for public queries
Name 42775 0
Ms Julie Flynn
Address 42775 0
Centre for Clinical Nursing
Level 2, Building 34
RBWH
Butterfield Street
Herston
Queensland 4029
Country 42775 0
Australia
Phone 42775 0
+61 7 36468293
Fax 42775 0
Email 42775 0
julie.flynn@griffith.edu.au
Contact person for scientific queries
Name 42776 0
Dr Samantha Keogh
Address 42776 0
Griffith University
Nathan Campus
Bldg N48 Rm 0.07
170 Kessels Road
Brisbane
Queensland 4111
Country 42776 0
Australia
Phone 42776 0
+ 61 7 36464121
Fax 42776 0
Email 42776 0
s.keogh@griffith.edu.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
EmbaseVaried flushing frequency and volume to prevent peripheral intravenous catheter failure: A pilot, factorial randomised controlled trial in adult medical-surgical hospital patients.2016https://dx.doi.org/10.1186/s13063-016-1470-6
N.B. These documents automatically identified may not have been verified by the study sponsor.