Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001147572p
Ethics application status
Submitted, not yet approved
Date submitted
17/08/2024
Date registered
23/09/2024
Date last updated
23/09/2024
Date data sharing statement initially provided
23/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Introducing a Vascular Access Specialist Model in the Emergency Department (VAS-ED)
Scientific title
Effect of Introducing a Vascular Access Specialist Model on First Insertion Success Rates for Adult Patients in the Emergency Department (VAS-ED)
Secondary ID [1] 312775 0
EMLE-283R41-2024-XU
Universal Trial Number (UTN)
Trial acronym
VAS-ED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intravenous device first insertion failure 334831 0
Condition category
Condition code
Emergency medicine 331388 331388 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this study are patients who require intravenous catheters (IVC) in emergency departments (ED). Consenting participants will receive a IVC inserted by a Vascular Access Specialist (nurses trained in ultrasound-guided IVC insertion) in the intervention group when a PIVC is required in ED. The IVC will remain in situ as long as it is required as per hospital policy. The insertion length of the IVC vary depending on the complexity of patient's venous condition and device is required. Patients will be monitored daily by a research nurse.
Intervention code [1] 329304 0
Prevention
Comparator / control treatment
PIVC inserted by a Generalist inserter (ED doctor or nurse)
Control group
Active

Outcomes
Primary outcome [1] 339135 0
First insertion success rate: on first insertion attempt, there is a visible presence of blood at IVC hub afterpiercing through the skin into the vein, and a successful flush of normal saline into the vein is achieved.
Timepoint [1] 339135 0
At the time of IVC insertion in ED.
Secondary outcome [1] 438687 0
Number of insertion attempts: needle punctures to insert device.
Timepoint [1] 438687 0
At the time of IVC insertion in ED.
Secondary outcome [2] 438688 0
IVC failure rate: any causes of ‘failure’ including infiltration/extravasation, occlusion, dislodgement, infection (laboratory-confirmed local or bloodstream infection), phlebitis and thrombosis (confirmed by ultrasound).
Timepoint [2] 438688 0
Daily from IVC insertion until 48 hours after IVC removal.
Secondary outcome [3] 438689 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 IVC; and localised IVC site infection (without bloodstream infection).
Timepoint [3] 438689 0
Daily from IVC insertion until 48 hours after PIVC removal.
Secondary outcome [4] 438690 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.
Timepoint [4] 438690 0
At the time of IVC removal.
Secondary outcome [5] 438691 0
Number and type of devices needed to complete IV treatment: Total numbers and types of vascular access devices are needed to complete IV treatment when patients are discharged from hospital or no vascular access devices are placed after 7 days.
Timepoint [5] 438691 0
At the end of discharge or 7 days post removal of the previous vascular access device
Secondary outcome [6] 438692 0
Patient satisfaction: on a 11-point Likert scale.
Timepoint [6] 438692 0
At the time of IVC insertion in ED.
Secondary outcome [7] 438693 0
Staff satisfaction: on a 11-point Likert scale.
Timepoint [7] 438693 0
At the time of IVC insertion in ED.
Secondary outcome [8] 438694 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 [8] 438694 0
Daily from IVC insertion until the time of IVC removal.

Eligibility
Key inclusion criteria
• 18 years and over
• likely being admitted into the hospital and requiring peripherally-compatible IV therapy for greater than or equal to 24 hours
• Informed written consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• 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 will screen patients daily and liaise with the staff responsible for inserting IVCs 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 research nurse. If this is given, the research nurse will log into a centralised web-based randomisation service customised for the trial and be advised of groupallocation. 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 IVC 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
6/01/2025
Actual
Date of last participant enrolment
Anticipated
29/08/2025
Actual
Date of last data collection
Anticipated
29/09/2025
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26958 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 43030 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 317208 0
Charities/Societies/Foundations
Name [1] 317208 0
Emergency Medicine Foundation Grant
Country [1] 317208 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Country
Australia
Secondary sponsor category [1] 319476 0
University
Name [1] 319476 0
Queensland University of Technology
Address [1] 319476 0
Country [1] 319476 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315945 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 315945 0
Ethics committee country [1] 315945 0
Australia
Date submitted for ethics approval [1] 315945 0
17/08/2024
Approval date [1] 315945 0
Ethics approval number [1] 315945 0
Ethics committee name [2] 315946 0
Queensland Human Ethics Committee
Ethics committee address [2] 315946 0
Ethics committee country [2] 315946 0
Australia
Date submitted for ethics approval [2] 315946 0
17/08/2024
Approval date [2] 315946 0
Ethics approval number [2] 315946 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136306 0
Dr Grace Xu
Address 136306 0
Emergency Trauma Center, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, Queensland, 4029
Country 136306 0
Australia
Phone 136306 0
+61 7 3646 2140
Fax 136306 0
Email 136306 0
[email protected]
Contact person for public queries
Name 136307 0
Grace Xu
Address 136307 0
Emergency Trauma Center, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, Queensland, 4029
Country 136307 0
Australia
Phone 136307 0
+61 7 3646 8111
Fax 136307 0
Email 136307 0
[email protected]
Contact person for scientific queries
Name 136308 0
Grace Xu
Address 136308 0
Emergency Trauma Center, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, Queensland, 4029
Country 136308 0
Australia
Phone 136308 0
+61 7 3646 8111
Fax 136308 0
Email 136308 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?

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.