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Trial registered on ANZCTR
Registration number
ACTRN12625001018404p
Ethics application status
Submitted, not yet approved
Date submitted
20/08/2025
Date registered
15/09/2025
Date last updated
15/09/2025
Date data sharing statement initially provided
15/09/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
A pilot randomised controlled trial assessing the impact of sharp short bevelled catheters on first-time insertion success
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Scientific title
A pilot randomised controlled trial assessing the impact of sharp short bevelled catheters on first-time insertion success in adult patients.
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Secondary ID [1]
315189
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Intravenous access
338633
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PIVC failure
338786
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Condition category
Condition code
Public Health
334925
334925
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Short bevelled peripheral intravenous catheter (SB-PIVC) (Surflo Zero, 3D-Shin®, Terumo Corporation, Tokyo, Japan)
The intervention will be delivered once per patient. The intervention time period (ie. device dwell time) will be as clinically indicated. PIVCs will be followed for their entire dwell time.
The SB-PIVC will be used at the recruiting hospital and inserted by hospital-credentialled research staff whilst the patient is in hospital and as clinically indicated.
The device will be monitored daily for the entirety of it's dwell by research staff to assess for protocol adherence and device complications.
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Intervention code [1]
331808
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Treatment: Devices
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Comparator / control treatment
Standard care PIVC (BD Insyte™ Autoguard™; BD Medical, Sandy UT, USA).
The standard PIVC will be inserted by hospital-credentialled research staff whilst the patient is in hospital and as clinically indicated.
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Control group
Active
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Outcomes
Primary outcome [1]
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Protocol feasibility
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Assessment method [1]
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A composite measure of Eligibility: over 60% of patients screened are eligible - determined from screening log. Recruitment (consent): over 80% of eligible participants agree to enrol - determined from screening log. Protocol adherence: over 90% of participants in the intervention groups receive their allocated treatment - determined from randomisation/intervention records. Retention and attrition: fewer than 5% of patients lost to attrition - determined from study records.
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Timepoint [1]
342559
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At conclusion of patient recruitment
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Primary outcome [2]
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Number of insertions where there is first-time insertion success
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Assessment method [2]
342560
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Defined as successful placement of the PIVC on the first attempt, without the need for additional attempts or interventions. Catheter positioning must be confirmed through visual inspection, blood returned/flashback, or other standard clinical techniques (such as ultrasound).
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Timepoint [2]
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At conclusion of device insertion.
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Secondary outcome [1]
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PIVC failure
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Assessment method [1]
451292
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Defined as premature device removal before the end of treatment, a composite measure of infiltration/extravasation; blockage/occlusion (with/without leakage); thrombosis; dislodgement (complete/partial); infection (laboratory-confirmed local/bloodstream infection) or phlebitis (pain score = 2/10; OR two or more of the following signs/symptoms: pain/tenderness greater than 1, erythema/redness, swelling, palpable cord, vein streak or purulence; OR patient reported as too painful to tolerate). Assessed using a combination of hospital records and patient feedback.
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Timepoint [1]
451292
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Assessed daily until device removal.
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Secondary outcome [2]
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Individual types of PIVC failure
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Assessment method [2]
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As defined in 'PIVC failure' secondary outcome. Infiltration/extravasation' blockage/occlusion; thrombosis; dislodgement; infection. Assessed using a combination of hospital records and patient feedback.
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Timepoint [2]
451293
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Assessed daily until device removal.
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Secondary outcome [3]
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PIVC dwell time
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Assessment method [3]
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Measured in hours from time of insertion to time of removal. Assessed using hospital records.
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Timepoint [3]
451294
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Assessed from time of device insertion to time of device removal.
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Secondary outcome [4]
451295
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Number of insertion attempts before successful PIVC placement
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Assessment method [4]
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Counted during insertion process. Reported by researcher.
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Timepoint [4]
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Assessed at time of PIVC insertion.
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Secondary outcome [5]
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Patient experience
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Assessment method [5]
451296
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Study-specific quality of life survey. A composite measure assessing Pain and discomfort (eg. I experienced pain during my PIVC insertion (No, slight, moderate, extreme)) Education and information (eg. I was informed about my PIVC, how it works and why I need it (No, somewhat, mostly, completely)) Distress and worry (I was distressed during my PIVC insertion (No, somewhat, moderate, extreme)) Staff communication and decision-making (eg. I felt staff listened to me (No, somewhat, mostly, completely)) Regular daily activities (eg. I was able to care for myself while my PIVC was in place (Not at all, somewhat, mostly, completely)) Confidence and safety (eg. I felt confident in the staff (Not at all, somewhat, mostly, completely)) Future healthcare interactions (eg. Because of my PIVC, I am fearful of attending healthcare facilities in the future (Not at all, somewhat, mostly, completely)) Harm (eg. Because of my PIVC I have experienced harm (No, slight, moderate, severe)
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Timepoint [5]
451296
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At time of PIVC removal
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Secondary outcome [6]
451297
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Time to insertion
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Assessment method [6]
451297
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Time from PIVC needle-to-skin to successful puncture of vein in minutes, as assessed by the researcher.
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Timepoint [6]
451297
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At the time of PIVC insertion
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Secondary outcome [7]
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Overall inserter satisfaction with the PIVC on insertion
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Assessment method [7]
451301
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10-point numerical scale: 0 = completely dissatisfied; 10 = completely satisfied.
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Timepoint [7]
451301
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At time of PIVC insertion.
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Eligibility
Key inclusion criteria
1. Patient greater than or equal to 16 years
2. PIVC required for greater than or equal to 24 hours
3. Identified as difficult PIVC insertion by meeting at least one of the following
a. Lack of visible and/or palpable veins
b. Medical history of DIVA or high risk for DIVA (eg. End-stage renal disease and receiving dialysis, IV drug user, sickle cell disease etc)
c. Prior failed PIVC insertion attempt
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Veins deeper than 1 cm from skin surface
2. Unable to provide informed consent
3. Previous study enrolment
4. End-of-life pathway
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation through a central, web-based randomisation service.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2025
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Actual
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Date of last participant enrolment
Anticipated
31/12/2025
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Actual
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Date of last data collection
Anticipated
9/01/2026
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Terumo Holdings Asia
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Address [1]
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Country [1]
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Japan
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Primary sponsor type
University
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Name
Griffith University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
322266
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Address [1]
322266
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Country [1]
322266
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
318315
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Metro North Health Human Research Ethics Committee
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Ethics committee address [1]
318315
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https://metronorth.health.qld.gov.au/research/ethics-and-governance/human-research-ethics-committee
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Ethics committee country [1]
318315
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Australia
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Date submitted for ethics approval [1]
318315
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15/07/2025
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Approval date [1]
318315
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Ethics approval number [1]
318315
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Summary
Brief summary
Aims: To determine the feasibility of a larger study in patients with difficult intravenous access to compare short-bevelled peripheral intravenous catheters (SB-PIVCs) with standard PIVCs. Participants: 100 adult patients from medical/surgical and oncology/haematology wards. 3-4 staff PIVC inserters for process evaluation. Methods: Pilot randomised controlled trial. Patients will be randomised to have either a SB-PIVC or standard PIVC inserted to facilitate their clinical care. Patients will be visited daily by research nurses for data collection. The study will end when the PIVC is removed as clinically indicated. Small process evaluation included. Expected outcomes: It will be feasible to conduct a larger trial and first-time insertion success will be higher in the SB-PIVC group than the standard PIVC group.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Nicole Marsh
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Address
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Nursing and Midwifery Research Centre, Level 8, Block 7, Royal Brisbane and Women's Hospital, Butterfield Street. Herston, Queensland, 4029
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Country
143790
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Australia
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Phone
143790
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+61 73646 8590
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Fax
143790
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Email
143790
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[email protected]
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Contact person for public queries
Name
143791
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Nicole Marsh
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Address
143791
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Nursing and Midwifery Research Centre, Level 8, Block 7, Royal Brisbane and Women's Hospital, Butterfield Street. Herston, Queensland, 4029
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Country
143791
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Australia
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Phone
143791
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+61 73646 8590
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Fax
143791
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Email
143791
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[email protected]
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Contact person for scientific queries
Name
143792
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Nicole Marsh
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Address
143792
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Nursing and Midwifery Research Centre, Level 8, Block 7, Royal Brisbane and Women's Hospital, Butterfield Street. Herston, Queensland, 4029
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Country
143792
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Australia
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Phone
143792
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+61 73646 8590
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Fax
143792
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Email
143792
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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
No additional documents have been identified.
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