ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

FliP

Linked study record

Health condition

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

Peripheral cannula maintenance

Condition category

Condition code

Infection

Studies of infection and infectious agents

Public Health

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]

Prevention

Intervention code [2]

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]

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]

While PIVC is insitu.

Secondary outcome [1]

Laboratory confirmed bloodstream infection.

Electronic pathology results will be check 48 hours after PIVC has been removed.

Timepoint [1]

While PIVC insitu or within 48 hours of PIVC removal

Secondary outcome [2]

Dwell time - will be calculated from the insertion date and removal date fields

Timepoint [2]

Following removal of PIVC

Secondary outcome [3]

Phlebitis

Timepoint [3]

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]

Dislodgement

Timepoint [4]

Data will be collected at the daily check when PIVC has been documented as dislodged

Secondary outcome [5]

Cost

Cost will be calculated based on the days each PIVC was insitu (per 1000 catheter days)

Timepoint [5]

Cost will be calculated at the completion of the trial

Secondary outcome [6]

Mortality

Timepoint [6]

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?

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]

Royal Brisbane & Womens Hospital - Herston

Funding & Sponsors

Funding source category [1]

University

Name [1]

Griffith University

Address [1]

Nathan Campus
170 Kessels Road
Nathan
Queensland, 4111

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Royal Brisbane & Women's Hospital

Address [2]

Butterfield Street
Herston
Queensland 4029

Country [2]

Australia

Primary sponsor type

University

Name

Griffith University

Address

Nathan Campus
170 Kessels Road
Nathan
Queensland, 4111

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane & Womens Hospital

Ethics committee address [1]

Butterfield Street
Herston
Queensland 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/12/2013

Approval date [1]

27/01/2014

Ethics approval number [1]

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

Dr Samantha Keogh

Address

Griffith University
Nathan Campus
Bldg N48 Rm 0.07
170 Kessels Road
Brisbane
Queensland 4111

Country

Australia

Phone

+ 61 7 36464121

Fax

s.keogh@griffith.edu.au

Contact person for public queries

Name

Julie Flynn

Address

Centre for Clinical Nursing
Level 2, Building 34
RBWH
Butterfield Street
Herston
Queensland 4029

Country

Australia

Phone

+61 7 36468293

Fax

julie.flynn@griffith.edu.au

Contact person for scientific queries

Name

Samantha Keogh

Address

Griffith University
Nathan Campus
Bldg N48 Rm 0.07
170 Kessels Road
Brisbane
Queensland 4111

Country

Australia

Phone

+ 61 7 36464121

Fax

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

Source	Title	Year of Publication	DOI
Embase	Varied flushing frequency and volume to prevent peripheral intravenous catheter failure: A pilot, factorial randomised controlled trial in adult medical-surgical hospital patients.	2016	https://dx.doi.org/10.1186/s13063-016-1470-6

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

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Documents added manually

Documents added automatically