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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12615000025538 |
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Date of registration:
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19/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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.
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Scientific title:
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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 |
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Date of first enrolment:
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28/04/2014 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12615000025538.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Factorial;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Samantha Keogh
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Address:
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Griffith University
Nathan Campus
Bldg N48 Rm 0.07
170 Kessels Road
Brisbane
Queensland 4111
Australia |
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Telephone:
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+ 61 7 36464121 |
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Email:
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s.keogh@griffith.edu.au |
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Affiliation:
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Name:
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Ms Julie Flynn
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Address:
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Centre for Clinical Nursing
Level 2, Building 34
RBWH
Butterfield Street
Herston
Queensland 4029
Australia |
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Telephone:
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+61 7 36468293 |
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Email:
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julie.flynn@griffith.edu.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients greater than or equal to 16 years of age
PIVC to be inserted for clinical care
Informed consent to participate
Exclusion criteria: Planned removal of PIVC within next 24hrs
Previous enrolment in the current study
Age minimum:
16 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Peripheral cannula maintenance;
Peripheral cannula maintenance
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Public Health - Health service research
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Infection - Studies of infection and infectious agents
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Intervention(s)
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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.
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Primary Outcome(s)
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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.[While PIVC is insitu.]
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Secondary Outcome(s)
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Phlebitis[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
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Dislodgement[Data will be collected at the daily check when PIVC has been documented as dislodged]
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Laboratory confirmed bloodstream infection.
Electronic pathology results will be check 48 hours after PIVC has been removed.[While PIVC insitu or within 48 hours of PIVC removal]
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Mortality[Rate of mortality will be assessed on completion of the trial]
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Cost
Cost will be calculated based on the days each PIVC was insitu (per 1000 catheter days)[Cost will be calculated at the completion of the trial]
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Dwell time - will be calculated from the insertion date and removal date fields[Following removal of PIVC]
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Source(s) of Monetary Support
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Griffith University
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Royal Brisbane & Women's Hospital
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Ethics review
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Status: Approved
Approval date:
Contact:
Royal Brisbane & Womens Hospital
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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