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Trial registered on ANZCTR


Registration number
ACTRN12622000299707p
Ethics application status
Submitted, not yet approved
Date submitted
3/02/2022
Date registered
16/02/2022
Date last updated
12/05/2022
Date data sharing statement initially provided
16/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial to test the effect of long peripheral intravenous catheter with retractable coilded tip guidewire on first insertion success rate in emergency department – Trial Protocol
Scientific title
A randomised controlled trial to test the effect of long peripheral intravenous catheter with retractable coilded tip guidewire on first insertion success rate in emergency department – Trial Protocol
Secondary ID [1] 306331 0
EMLE-201R36-2021-XU
Universal Trial Number (UTN)
Trial acronym
LOVE-DIVA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intravenous device first insertion failure 325122 0
Condition category
Condition code
Emergency medicine 322531 322531 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this study are patients who have difficult intravenous access and require peripheral intravenous catheters (PIVC) in emergency departments. Consenting participants will have either AccuCath Ace™ Intravascular Cannula (AC-PIVC) in the intervention group or standard care PIVC in the control group. The PIVCs will be inserted by either the Research Nurse or the treating clinician.

Intervention group: AC- PIVC. Long AccuCath™ (BD, Salt lake City, UT, USA) peripheral intravenous catheter (5.8cm length) has a retractable coiled tip guidewire.

The randomly allocated PIVCs will be inserted at the time of PVC insertion in ED until device removal. There will be daily checks of the PIVC site to monitor protocol adherence and assess for any complications.
Intervention code [1] 322766 0
Prevention
Intervention code [2] 322767 0
Treatment: Devices
Comparator / control treatment
Control group: Short/long PIVC. Short PIVC catheter (<4 cm length e.g. Introcan Safety®3 catheter, B Braun); or long PIVC catheter (4.5-6.4cms length, e.g. BD Insyte™ Autoguard™ BD, Introcan Safety®3 catheter, B Braun)
Control group
Active

Outcomes
Primary outcome [1] 330322 0
First-time insertion success: on first insertion attempt, there is a visible presence of blood at PIVC hub after piercing through the skin into the vein, and a successful flush of normal saline into the vein is achieved. This outcome will be assessed either by the Research Nurse or reported by the treating clinician.
Timepoint [1] 330322 0
At the time of PIVC insertion in ED.
Secondary outcome [1] 405826 0
Number of insertion attempts: needle punctures to insert device. This outcome will be assessed either by the Research Nurse or reported by the treating clinician.
Timepoint [1] 405826 0
At the time of PIVC insertion in ED.
Secondary outcome [2] 405827 0
Time to insert device: from randomisation to successful insertion. This outcome will be assessed by using stopwatch either by the Research Nurse or reported by the treating clinician .
Timepoint [2] 405827 0
At the time of PIVC insertion in ED.
Secondary outcome [3] 405828 0
PIVC failure rate: any causes of ‘failure’ including infiltration/extravasation, occlusion, dislodgement, infection (laboratory-confirmed local or bloodstream infection), phlebitis and thrombosis (confirmed by ultrasound). This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Timepoint [3] 405828 0
Daily from PIVC insertion until 48 hours after PIVC removal.
Secondary outcome [4] 405829 0
Device dwell-time: time from insertion to removal (in hours). This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record. The specific removal time (in hours and minutes) will be timed by watch and recorded on the data collection sheet.
Timepoint [4] 405829 0
At the time of PIVC removal.
Secondary outcome [5] 405830 0
Patient reported pain of insertion procedure: on 0-10 Verbal Rating Scale.
Timepoint [5] 405830 0
At the time of PIVC insertion in ED.
Secondary outcome [6] 405831 0
Serious adverse events: e.g. ICU admission. This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Timepoint [6] 405831 0
Daily from PIVC insertion until 48 hours after PIVC removal.
Secondary outcome [7] 405832 0
Individual complications: infiltration/extravasation, occlusion, phlebitis or infection (positive blood culture from the peripheral vein; clinical signs of infection with no other apparent source except the PIVC; and localised PIVC site infection (without bloodstream infection) This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Timepoint [7] 405832 0
Daily from PIVC insertion until 48 hours after PIVC removal.
Secondary outcome [8] 405833 0
Subsequent vascular devices are required: until discharge or insertion of CVAD. This will be assessed by either the Research Nurse (during daily checks) or (if identified by the treating clinician) recorded in the patient's medical record
Timepoint [8] 405833 0
until discharge or insertion of CVAD
Secondary outcome [9] 405834 0
Patient satisfaction: on a 5-point Likert scale.
Timepoint [9] 405834 0
At the time of PIVC insertion in ED.
Secondary outcome [10] 405835 0
Staff satisfaction: on a 5-point Likert scale.
Timepoint [10] 405835 0
At the time of PIVC insertion in ED.
Secondary outcome [11] 405836 0
Cost data: will be collected at both arms. It will focus on collecting direct variable costs (e.g. cost and number of products used and staff for device insertion; costs of treating complications) in a subset of 30 per arm.
Timepoint [11] 405836 0
Daily from PIVC insertion until the time of PIVC removal.

Eligibility
Key inclusion criteria
• >18 years
• Require PIVC as part of treatment
• Identified as difficult PIVC insertion by meeting at least one of the criteria: (1) lack of visible or palpable vein; (2) history of DIVA or medical history suggesting DIVA; (3) failed one PIVC insertion attempt
• Informed written consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Presence of a co-existent, or requiring a central venous access device (CVAD) or midline
• Patients with upper arm limitations (e.g. mastectomy, renal patients)
• Non-English-speaking patients without an interpreter
• Patients requiring urgent care (e.g. triage category one)
• Patient receiving end-of-life care
• Previous enrolment in the 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)
Research nurses (ReNs) will screen patients daily and liaise with the staff responsible for inserting PIVCs in ED. All eligible patients will be approached by staff who will ask patient's permission to be approached. Once they agree, a written informed consent will be obtained by the ReN. If this is given, the ReN will log in to a centralised web-based randomisation service customised for the trial and be advised of group allocation. Computer generated allocation is provided by an independent randomisation service. Allocation is fully concealed until the patient is randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be in a 1:1 ratio between the two study groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All randomised patients will be analysed on an Intention to Treat basis. The patient is the unit of measurement with one PIVC per patient being analysed. Categorical data will be presented as frequencies and percentages. Continuous data will be presented as means and medians.

Logistic regression will be used to assess first insertion success. Kaplan-Meier survival curves will compare time to device failure rate. Continous variables will be presented as linear regression. Binary outcomes comparsion will use logistic regression while count outcomes by Poission regression. Multivariate regression (Cox) models will test the effect of patient and device variables associated with device failure. Data will be exported into Stata. Prior to analysis, data cleaning of outlying figures, missing, and implausible data will be undertaken, and a random 5% sample of source data re-entered and checked.

Missing data will be modelled for best- and worst-case outcomes to assess for effect on overall results. P values of <0.05 will be considered significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/06/2022
Actual
Date of last participant enrolment
Anticipated
29/03/2024
Actual
Date of last data collection
Anticipated
15/04/2024
Actual
Sample size
Target
406
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21635 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [2] 21636 0
Logan Hospital - Meadowbrook
Recruitment postcode(s) [1] 36564 0
4108 - Coopers Plains
Recruitment postcode(s) [2] 36565 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 310684 0
Charities/Societies/Foundations
Name [1] 310684 0
Emergency Medicine Foundation Grant
Country [1] 310684 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Rd, Nathan QLD 4111
Country
Australia
Secondary sponsor category [1] 311912 0
Hospital
Name [1] 311912 0
QEII Hospital
Address [1] 311912 0
Kessels Rd &, Troughton Rd, Coopers Plains QLD 4108
Country [1] 311912 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310269 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 310269 0
Level 7, Translational Research Institute Building
Princess Alexandra Hospital
Ipswich Road, Woolloongabba Qld 4102
Ethics committee country [1] 310269 0
Australia
Date submitted for ethics approval [1] 310269 0
13/01/2022
Approval date [1] 310269 0
Ethics approval number [1] 310269 0
Ethics committee name [2] 310275 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 310275 0
170 Kessels Rd, Nathan QLD 4111
Ethics committee country [2] 310275 0
Australia
Date submitted for ethics approval [2] 310275 0
13/01/2022
Approval date [2] 310275 0
Ethics approval number [2] 310275 0

Summary
Brief summary
The primary aim of this randomised controlled trial (RCT) is to compare the clinical and cost effectiveness of new generation peripheral intravenous catheter (PIVC) products with the standard care PIVCs.

You may be eligible to participate in this trial if you are an emergency department patient more than the age of 18 and are requiring a peripheral venous catheter inserted as part of your therapy.

All participants enrolled in this trial will be randomly allocated (by chance) to receive one of two PIVC options. This will be either the standard PIVC, or a PIVC with a retractable coiled guidewire. The allocated device will be kept from device insertion until the time of device removal. Participants and families will be asked to rate the satisfaction of the device, and the device will be observed closely to examine side effects, device failures and infections. It is hoped that the findings of this trial will provide information on which PIVC devices are most effective in preventing first insertion failure.
Trial website
Trial related presentations / publications
Public notes
This study is funded by Emergency Medicine Foundation Grant.

Contacts
Principal investigator
Name 117070 0
Ms Hui (Grace) Xu
Address 117070 0
National Health and Medical Research Council Centre of Research Excellence in Wiser Wound Care
Griffith University, Nathan Campus
170 Kessels Rd
Nathan QLD 4111
Country 117070 0
Australia
Phone 117070 0
+61737357236
Fax 117070 0
Email 117070 0
[email protected]
Contact person for public queries
Name 117071 0
Hui (Grace) Xu
Address 117071 0
National Health and Medical Research Council Centre of Research Excellence in Wiser Wound Care
Griffith University, Nathan Campus
170 Kessels Rd
Nathan QLD 4111
Country 117071 0
Australia
Phone 117071 0
+61737357236
Fax 117071 0
Email 117071 0
[email protected]
Contact person for scientific queries
Name 117072 0
Hui (Grace) Xu
Address 117072 0
National Health and Medical Research Council Centre of Research Excellence in Wiser Wound Care
Griffith University, Nathan Campus
170 Kessels Rd
Nathan QLD 4111
Country 117072 0
Australia
Phone 117072 0
+61737357236
Fax 117072 0
Email 117072 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14914Ethical approval  [email protected] Please contact the principal investigator.



Results publications and other study-related documents

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