Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001362886p
Ethics application status
Submitted, not yet approved
Date submitted
27/08/2021
Date registered
8/10/2021
Date last updated
12/09/2022
Date data sharing statement initially provided
8/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of teaching techniques on medical students' intravenous cannulation first time success rate
Scientific title
Flatten and Advance while Lifting the Tip (FALT) Trial: Adaptive three arm RCT of effectiveness of teaching tip lifting to medical students on improving intravenous cannulation first time success rate
Secondary ID [1] 305157 0
None
Universal Trial Number (UTN)
Trial acronym
Flatten and Advance while Lifting the Tip (FALT)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
need for intravenous cannulation 323420 0
Condition category
Condition code
Public Health 320971 320971 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Medical students, at the commencement of the study, will each watch one of three randomly allocated educational videos (each 10-20 minutes long) aiming to improve their ability to place intravenous cannulas. The videos will be supplied on-line with the expectation that they watch the video at least once. They will receive periodic (~6 monthly) email reminders of the key contents of the video. Compliance will only be monitored by a post video questionnaire. Students will be volunteers and expected to be reasonably compliant.

The "control" video will just contain established tips for placing cannulas. The first "theory" group will receive additional instruction on the geometry of the cannula needle tip and how it is at risk of perforating the bottom (deep) layer of the vein but is virtually impossible to perforate the roof (superficial) layer once it has entered the lumen. The final group (theory plus practical) group will get futher instruction to practice the physical act of lifting the tip of the cannula by inserting a standard sharp drawing up needle on a 3ml syringe between the layers of an alcohol prep pad. These interventions are described here: https://docs.google.com/document/d/1FHtAO0bjNAdF9xzKzwxhcSQCODJAUtAe/edit?usp=sharing&ouid=107291495832032321355&rtpof=true&sd=true

Intervention code [1] 321561 0
Treatment: Devices
Comparator / control treatment
Students in control arm will watch 10-20 minute video containing well established cannula placement tips.
Control group
Active

Outcomes
Primary outcome [1] 328741 0
First-time success rate for medical students placing cannulas in patients assessed by participant self-report through study-specific questionnaire.
Timepoint [1] 328741 0
After watching the intervention video, students will progressively report the outcomes on their first 20 cannulation attempts. This will be continuously during their final 2 years of clinical training (3rd and 4th year).
Secondary outcome [1] 400224 0
Location of cannulas placed by medical students (as self-reported by the student)
Timepoint [1] 400224 0
After watching the intervention video, students will progressively report the outcomes on their first 20 cannulation attempts. This will be continuously during their final 2 years of clinical training (3rd and 4th year).
Secondary outcome [2] 400987 0
Size of cannulas placed by medical students. (as self-reported by the student)
Timepoint [2] 400987 0
After watching the intervention video, students will progressively report the outcomes on their first 20 cannulation attempts. This will be continuously during their final 2 years of clinical training (3rd and 4th year).

Eligibility
Key inclusion criteria
Medical students entering their 3rd year of training
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unwillingness to consent to participate and follow protocols.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random block size block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Initial power studies show a minimum sample size of between 50 and over 300 per group depending on assumed student success rate and student variability.

A definitive power calculation will occur using the overall success rates observed across the combined first 6 months of data based on alpha=0.05, beta = 0.8, yielding a sample target (Nt).

Three interim analyses using the Pocock stopping rules (alpha = 0.021) will occur at Nt, Nt x 2 and Nt x 3.

For example if power calculation based on the first 6 months of data reveals a required sample of 142 students per group, then interim analysis will occur at 142, 284 completed students with the recruitment terminating when, allowing for drop-outs, 426 students are expected to complete the trial.

Primary outcome will be assessed with simple uni-variate tests, with multivariate tests used for secondary analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2023
Actual
Date of last participant enrolment
Anticipated
1/04/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 309546 0
Hospital
Name [1] 309546 0
Mater Health
Country [1] 309546 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
The University of Queensland, 288 Herston Road, Brisbane, QLD 4006
Country
Australia
Secondary sponsor category [1] 310541 0
Hospital
Name [1] 310541 0
Mater Health
Address [1] 310541 0
Raymond Tce
South Brisbane
Qld 4101
Country [1] 310541 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309326 0
Royal Brisbane and Women’s Hospital Human Research Ethics Committee (EC00172)
Ethics committee address [1] 309326 0
Level 14 Block 7
Royal Brisbane and Women's Hospital
Cnr Butterfield St and Bowen Bridge Rd
HERSTON QLD 4029
Ethics committee country [1] 309326 0
Australia
Date submitted for ethics approval [1] 309326 0
30/08/2021
Approval date [1] 309326 0
Ethics approval number [1] 309326 0

Summary
Brief summary
Health service often requires healthcare workers (typically doctors and nurses) to place a thin plastic tube into patients' veins called an intravenous cannula (IVC). Placing an IVC is one the most commonly performed medical procedures. It is estimated that every year 2 billion IVCs are sold around the world and over 7 million Australians have an IVC placed.
Despite the huge numbers of IVCs placed each year, inexperienced clinicians often take many attempts to successfully place one. This causes pain for patients and, in an emergency, failure to rapidly place an IVC can cause serious patient harm including death.
There are some recent realisations about how the shape of the IVC tip influences the proper approach to placing the IVC. If these realisations are effective at improving IVC success rates then this will impact on millions of people.
This study will test this by randomly allocating students to watch different videos. Each video will contain helpful tips for the students to place IVCs but only some students will be shown novel details about the recent realisations. A subset of students will also learn a novel method of practicing a critical step of placing the IVC.

Students will then report back the outcome of their first 20 IVC attempts. This will enable us to test if the realisations and the novel practice method lead to less failed IVC placement attempts.

The research team will monitor the results using predefined stopping rules.

We hypothesise that teaching the theory of lifting of needle tip will increase cannulation success rates. We further hypothesise that the using the hands-on alcohol wipe teaching model will have an additional benefit beyond purely theoretical instruction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113774 0
Dr Erich Schulz
Address 113774 0
Department of Anaesthesia
Mater Health
Salmon Building
Raymond Tce
South Brisbane
Qld 4101
Country 113774 0
Australia
Phone 113774 0
+61 7 31638646
Fax 113774 0
Email 113774 0
[email protected]
Contact person for public queries
Name 113775 0
Dr Erich Schulz
Address 113775 0
Department of Anaesthesia
Mater Health
Salmon Building
Raymond Tce
South Brisbane
Qld 4101
Country 113775 0
Australia
Phone 113775 0
+61 7 31638646
Fax 113775 0
Email 113775 0
[email protected]
Contact person for scientific queries
Name 113776 0
Dr Erich Schulz
Address 113776 0
Department of Anaesthesia
Mater Health
Salmon Building
Raymond Tce
South Brisbane
Qld 4101
Country 113776 0
Australia
Phone 113776 0
+61 7 31638646
Fax 113776 0
Email 113776 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all data (de-identified)
When will data be available (start and end dates)?
after publication of results for for 5 years after publication
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
research
How or where can data be obtained?
By contacting the Principal Investigator [email protected]


What supporting documents are/will be available?




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.