Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001054404
Ethics application status
Approved
Date submitted
25/08/2025
Date registered
24/09/2025
Date last updated
24/09/2025
Date data sharing statement initially provided
24/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating a Tap-Per-Breath Mobile Application for Respiratory Rate Measurement in Paramedicine: A Pseudo-Randomised Controlled Trial
Scientific title
Accuracy and Time-to-Measurement of a Tap-Per-Breath Mobile Application for Respiratory Rate Assessment among Paramedicine Students in Simulation: A Pseudo-Randomised Crossover Trial
Secondary ID [1] 315140 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiration rate assessment in simulated emergency patients (healthy volunteers) 338568 0
Condition category
Condition code
Respiratory 334871 334871 0 0
Other respiratory disorders / diseases
Emergency medicine 335097 335097 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A “tap-per-breath” mobile application installed on an investigator-supplied smartphone/iPod. Participants tap the screen in time with the patient’s visible respirations; the app derives RR from inter-tap intervals using a minimum of 5 taps (accepting additional taps if all taps are not within the 13% consistency threshold calculated from a rolling median). A 30-second ceiling applies to the app algorithm. A short video tutorial shows correct use.

Each participant completes two 10-minute simulated patient assessments (crossover). In the intervention assessment they will be given a phone with the tap-bpm app installed, after training video watched (made specifically for the research project); in the control assessment they use standard manual counting (watch/clock). Participants record vital signs when they deem clinically indicated; investigators time-stamp when RR is begun/announced and collect whether RR was measured.

Trained study staff (investigators) supervise, instruct, time-stamp, and collect forms.

In-person, individual simulations in university simulation labs for paramedicine students.

One study visit (~40 minutes): 10 minutes per scenario. A short washout period between sessions (target; minimum 5, maximum 10, logged), plus ~10 minutes for survey.

University paramedicine simulation classrooms with standard equipment (e.g., monitors, BP cuffs) and controlled ambient noise (audio track at a standardised volume).

Direct observation with checklists; automatic app logs (where available); time-stamps for start/announcement of RR; and documentation of any deviations or non-measurement.
Intervention code [1] 331766 0
Diagnosis / Prognosis
Intervention code [2] 331767 0
Early detection / Screening
Comparator / control treatment
Control: Standard manual RR counting using a wristwatch or wall clock, at the participant’s discretion within the control scenario.

Allocation/choice clarification: Participants do not choose their sequence; they are pseudo-randomly assigned to Intervention-then-Control or Control-then-Intervention. Within the control scenario, if a participant elects not to measure RR, this is recorded for the secondary outcome (proportion measuring RR).

Reference standard: Accuracy/time for both methods are compared against the criterion RR set by the metronome worn by the simulated patient. A pilot session prior to data collection and participant recruitment will be used to determine compliance with in-ear metronome to breathing rate. Each simulated patient will undertake a pilot session prior to data collection.
Control group
Active

Outcomes
Primary outcome [1] 342583 0
Accuracy of respiratory rate measurement
Timepoint [1] 342583 0
Immediately during each simulation session (at the point the participant records the respiratory rate)
Primary outcome [2] 342584 0
Time taken to measure respiratory rate
Timepoint [2] 342584 0
Immediately during each simulation session (at the point the participant records the respiratory rate)
Secondary outcome [1] 451396 0
Proportion of participants who measure respiratory rate
Timepoint [1] 451396 0
Immediately during each simulation session (at the point respiratory rate measurement is attempted)
Secondary outcome [2] 451397 0
Cognitive load during respiratory rate measurement
Timepoint [2] 451397 0
Immediately after each simulation session (upon completion of the patient assessment scenarios)

Eligibility
Key inclusion criteria
Undergraduate and postgraduate paramedicine/emergency healthcare students. Students who have passed a unit of study which includes competence in patient assessment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation list (pseudo-randomisation schedule) will allocate participants to one of two sequence groups:

Group 1: Intervention (tap-per-breath mobile application) first, then Control (manual watch/clock method)

Group 2: Control first, then Intervention.
A washout period of 5–10 minutes will minimise carryover effects.

Computer-generated blocked randomisation lists were created using the Sealed Envelope “Create a blocked randomisation list” tool with equal allocation to the two crossover sequences (AB = Intervention then Control; BA = Control then Intervention), fixed block size = 4, and stratification by teaching session/site to maintain balance within each class. A pre-specified seed was used and archived in the study file; lists were exported as CSV (one per stratum). The generator produces random permutations within each block using a pseudo-random number engine, yielding 1:1 balance within blocks while preserving unpredictability of the next assignment.

Sealed Envelope Ltd. 2024. Create a blocked randomisation list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 6 Sep 2025].
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In collaboration with a statistician (co-investigator), a power calculation was performed using G*Power designed to detect a 10% difference in the primary outcomes (accuracy of RR and time taken to completion). With the crossover design this equated to at least 50 participants in the sample size to appropriately power the study.
The following inputs were used within G*Power: Effect size (Cohen’s dz): 0.525
Alpha (a): 0.05
Power (1-ß): 0.80
Test family: t-tests
Statistical test: Means: Difference between two dependent means (matched pairs) Tail(s): One-tailed (potential for bias to under of overestimate RR results)
An interim power calculation will be conducted once 50 participants have been recruited to assess whether the study remains adequately powered to detect a meaningful effect. This approach will help guide recruitment while minimising unnecessary participant enrolment. The re- estimation will be conducted in a blinded manner to maintain the integrity of the study and reduce potential bias. Further to this, power analysis will be conducted every 5 participants above 50 to detect if further recruitment is required.

Mean difference (delta-RR) and mean absolute error (MAE) between participant-measured RR (using the tap-per-breath mobile application or manual counting) and the actual RR set by metronome (criterion).
Analyses: paired t-tests for method comparisons; Bland–Altman to assess bias and limits of agreement.

The proportion of participants who recorded RR will be calculated as (number of participants who measured respiratory rate ÷ total participants per group), compared between groups using chi-square test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/10/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 319717 0
Self funded/Unfunded
Name [1] 319717 0
Country [1] 319717 0
Primary sponsor type
Individual
Name
Lachlan F D Sallabank, Victoria University
Address
Country
Australia
Secondary sponsor category [1] 322225 0
University
Name [1] 322225 0
Victoria University
Address [1] 322225 0
Country [1] 322225 0
Australia
Other collaborator category [1] 283628 0
Individual
Name [1] 283628 0
Brian Haskins, Victoria University
Address [1] 283628 0
Country [1] 283628 0
Australia
Other collaborator category [2] 283629 0
Individual
Name [2] 283629 0
James Oswald, Ambulance Victoria
Address [2] 283629 0
Country [2] 283629 0
Australia
Other collaborator category [3] 283630 0
Individual
Name [3] 283630 0
Jerome Rachele, Victoria University
Address [3] 283630 0
Country [3] 283630 0
Australia
Other collaborator category [4] 283631 0
Individual
Name [4] 283631 0
James King, University of Notre Dame
Address [4] 283631 0
Country [4] 283631 0
Australia
Other collaborator category [5] 283632 0
Individual
Name [5] 283632 0
Caroline Martin, La Trobe University
Address [5] 283632 0
Country [5] 283632 0
Australia
Other collaborator category [6] 283633 0
Individual
Name [6] 283633 0
Emalee Outlaw, Victoria University
Address [6] 283633 0
Country [6] 283633 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318270 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 318270 0
Ethics committee country [1] 318270 0
Australia
Date submitted for ethics approval [1] 318270 0
26/05/2025
Approval date [1] 318270 0
19/08/2025
Ethics approval number [1] 318270 0
HRE25-076

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

Contacts
Principal investigator
Name 143654 0
Dr Brian Haskins
Address 143654 0
Victoria University, University Boulevard, St Albans, VIC 3021
Country 143654 0
Australia
Phone 143654 0
+61 466 045 119
Fax 143654 0
Email 143654 0
[email protected]
Contact person for public queries
Name 143655 0
Lachlan Sallabank
Address 143655 0
Victoria University, University Boulevard, St Albans, VIC 3021
Country 143655 0
Australia
Phone 143655 0
+61 498739813
Fax 143655 0
Email 143655 0
[email protected]
Contact person for scientific queries
Name 143656 0
Lachlan Sallabank
Address 143656 0
Victoria University, University Boulevard, St Albans, VIC 3021
Country 143656 0
Australia
Phone 143656 0
+61 498739813
Fax 143656 0
Email 143656 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval2025   Ethics approval email notification. No letter has ... [More Details] ETHICS APPROVAL EMAIL.pdf


Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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