Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000314820
Ethics application status
Approved
Date submitted
14/02/2021
Date registered
22/03/2021
Date last updated
22/03/2021
Date data sharing statement initially provided
22/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Securing Cannulas in Combat: a simulation-based mixed method study
Scientific title
The S2C Study -Securing Cannulas in Combat: a simulation-based mixed method study
Secondary ID [1] 303450 0
none
Universal Trial Number (UTN)
none
Trial acronym
S2C
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral intravenous catheter failure 320754 0
Shock 320755 0
haemorrhage 321195 0
Condition category
Condition code
Emergency medicine 318588 318588 0 0
Other emergency care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A pragmatic mixed-method design with two phases will be used to compare the Ranger IV method to the S-Wrap technique to reduce PIVC dislodgement rates during TCCC simulations.

In Phase 1, the effectiveness of each method to prevent cannula dislodgement in vitro will be evaluated. Specifically, we will investigate the pull-out force in vitro of two PIVC securement methods. Pull-out force is defined in this study as the tensile force (N) required to produce PIVC dislodgement; this attempts to replicate how a PIVC administration line may become caught on a fixed object (e.g. tree branch, stretcher, body armour) in an austere combat setting. Pig skin (i.e. pork belly) will be used as a surrogate for human skin because it shares similar epidermal and dermal thickness ratios to human skin.

In Phase 2, an observational audit of TCCC training will be conducted to understand the quality and safety of each method. At the completion of the final TCCC simulated practice scenario (approx 2 hour), focus groups with health care professionals will occur to explore their experiences of simulated PIVC insertion and securement practices.

This study will be conducted in conjunction with existing defence health training courses and participants completing the simulated tactical care of the casualty course (TCCC) will be invited to participate. Due to the TCCC course requirements, all participants receive familiarisation training and will practise both the Ranger IV and S-Wrap PIVC securement methods and cannulate simulated casualties via a Laerdal™ training arm. During the combat field phase of TCCC course students who choose to participate in the study will be randomly allocated by their instructor to use either the Ranger IV method or the S-Wrap method. Consenting participants will have demographic data collected: e.g. rank, previous experience in cannulation, method approach used during TCCC, and current healthcare qualifications. The quality and safety of PIVC securement will be monitored, the recruitment target is 30 participants, and data collection will occur for each participant and to reach recruitment goal should take six months. Participants will be observed for evidence of PIVC insertion and securement complications using an observational field guide. The field guide has been developed for this study to focus observations and will be pilot tested prior to use. Maintaining situation awareness is a fundamental component of TCCC; thus, the time taken to complete the securement method will also be included in the field guide.
Intervention code [1] 319745 0
Not applicable
Comparator / control treatment
Ranger IV is the reference securement method
Control group
Active

Outcomes
Primary outcome [1] 326546 0
Peripheral intravenous catheter (PIVC) failure will be considered to have occurred if the catheter was an unplanned removal from any cause (includes infiltration, blockage, accidental removal). This information will be collected by the research nurse from either direct observation, consultation with the TCCC staff or review of training casualty treatment records/filed medical records..
Timepoint [1] 326546 0
Monitored on a daily basis during the field phase of TCCC.
Primary outcome [2] 326910 0
Pull out force (N); Pull-out force is defined in this study as the tensile force (N) required to produce PIVC dislodgement.
Timepoint [2] 326910 0
measured during Phase 1. Three PIVCs will be secured using the Ranger IV method, three using the S-Wrap method, and three combining an armboard with the S-Wrap method.
Secondary outcome [1] 391825 0
Stop watch-Time taken to complete the securement method (minutes)
Timepoint [1] 391825 0
Monitored on a daily basis during the field phase of TCCC.

Eligibility
Key inclusion criteria
1. All defence healthcare professionals (e.g. nurses, medical doctors, paramedics, combat medics) attending the TCCC will be eligible for participation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
trainees < 18 years of age.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be used to summarise audit data, including the use of mean/median, range and standard deviation values (as appropriate) for continuous data, and frequencies and percentages for categorical data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/04/2021
Actual
Date of last participant enrolment
Anticipated
27/08/2021
Actual
Date of last data collection
Anticipated
27/08/2021
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 33158 0
3691 - Bandiana

Funding & Sponsors
Funding source category [1] 307867 0
Other
Name [1] 307867 0
Army School of Health
Country [1] 307867 0
Australia
Primary sponsor type
Other
Name
Army School of Health
Address
Latchford Barracks, Bandiana MILPO, Victoria, Australia 3694
Country
Australia
Secondary sponsor category [1] 308576 0
University
Name [1] 308576 0
Griffith University
Address [1] 308576 0
170 Kessels Road, Nathan Qld 4111
Country [1] 308576 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307870 0
Departments of Defence and Veterans’ Affairs Human Research Ethics Committee
Ethics committee address [1] 307870 0

CP3-6-049 Campbell Park Offices, PO Box 7911, Canberra BC ACT 2610
Ethics committee country [1] 307870 0
Australia
Date submitted for ethics approval [1] 307870 0
08/02/2021
Approval date [1] 307870 0
24/02/2021
Ethics approval number [1] 307870 0
2021/BN27122396

Summary
Brief summary
Haemorrhage is a significant cause of preventable death in combat settings. Clinical practice guidelines advocate for the rapid delivery of intravenous fluid bolus challenges for the hypovolemic trauma patient in the tactical environment. However, peripheral intravenous catheter (PIVC) insertion is challenging in the austere setting and failure is common. The aim of this study is to investigate dressing and securement methods that prevent catheter dislodgement and explore participants’ experiences with these devices within an Australian Defence Force tactical care of the casualty (TCCC) training course. A two phase mixed-method design will be used to compare the Ruggedised Field (Ranger) IV method to the S-Wrap technique to reduce PIVC dislodgement rates during TCCC simulations. The study will be undertaken at the Australian Army School of Health in Victoria, Australia. Observational data from this study will reveal securement techniques that optimise practice in high threat/disaster settings and enhance patient safety and quality.
Trial website
none
Trial related presentations / publications
none
Public notes
none

Contacts
Principal investigator
Name 108762 0
Dr Benjamin Mackie
Address 108762 0
Australian Army, Army School of Health, VIC, Latchford Barracks, Bandiana MILPO, 3694 Australia.
Country 108762 0
Australia
Phone 108762 0
+61 0432027105
Fax 108762 0
Email 108762 0
Benjamin.mackie@defence.gov.au
Contact person for public queries
Name 108763 0
Dr Benjamin Mackie
Address 108763 0
Australian Army, Army School of Health, VIC, Latchford Barracks, Bandiana MILPO, 3694 Australia.
Country 108763 0
Australia
Phone 108763 0
+61 0432027105
Fax 108763 0
Email 108763 0
Benjamin.mackie@defence.gov.au
Contact person for scientific queries
Name 108764 0
Dr Benjamin Mackie
Address 108764 0
Australian Army, Army School of Health, VIC, Latchford Barracks, Bandiana MILPO, 3694 Australia.
Country 108764 0
Australia
Phone 108764 0
+61 0432027105
Fax 108764 0
Email 108764 0
Benjamin.mackie@defence.gov.au

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.