ANZCTR - Registration

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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

8/09/2024

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]

None

Universal Trial Number (UTN)

U1111-1312-9558

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

Condition category

Condition code

Public Health

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]

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]

First-time success rate for medical students placing cannulas in patients assessed by participant self-report through study-specific questionnaire.

Timepoint [1]

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]

Location of cannulas placed by medical students (as self-reported by the student)

Timepoint [1]

Secondary outcome [2]

Size of cannulas placed by medical students. (as self-reported by the student)

Timepoint [2]

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

1/01/2025

Actual

Date of last participant enrolment

Anticipated

31/12/2028

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]

Hospital

Name [1]

Mater Health

Address [1]

Mater Health
Raymond Tce
South Brisbane
Qld 4101

Country [1]

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]

Hospital

Name [1]

Mater Health

Address [1]

Raymond Tce
South Brisbane
Qld 4101

Country [1]

Australia

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Royal Brisbane and Women’s Hospital Human Research Ethics Committee (EC00172)

Ethics committee address [1]

Level 14 Block 7
Royal Brisbane and Women's Hospital
Cnr Butterfield St and Bowen Bridge Rd
HERSTON QLD 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/08/2021

Approval date [1]

Ethics approval number [1]

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

Dr Erich Schulz

Address

Department of Anaesthesia
Mater Health
Salmon Building
Raymond Tce
South Brisbane
Qld 4101

Country

Australia

Phone

+61 7 31638646

Fax

Erich.Schulz@mater.org.au

Contact person for public queries

Name

Erich Schulz

Address

Department of Anaesthesia
Mater Health
Salmon Building
Raymond Tce
South Brisbane
Qld 4101

Country

Australia

Phone

+61 7 31638646

Fax

Erich.Schulz@mater.org.au

Contact person for scientific queries

Name

Erich Schulz

Address

Department of Anaesthesia
Mater Health
Salmon Building
Raymond Tce
South Brisbane
Qld 4101

Country

Australia

Phone

+61 7 31638646

Fax

Erich.Schulz@mater.org.au

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 erich.schulz@mater.org.au

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details
13006	Analytic code	erich.schulz@mater.org.au	By contacting the Principal Investigator erich.sch... [More Details]
13007	Ethical approval	erich.schulz@mater.org.au	By contacting the Principal Investigator
13008	Study protocol	erich.schulz@mater.org.au	By contacting the Principal Investigator
13009	Informed consent form	erich.schulz@mater.org.au	By contacting the Principal Investigator

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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