Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000383460
Ethics application status
Approved
Date submitted
18/02/2016
Date registered
23/03/2016
Date last updated
12/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison between a computerized skill-reporting system (QCPR) versus standard instructor-based feedback for chest compression skill acquisition in secondary school students. A randomized study.
Scientific title
Comparison between QCPR software and instructor-based learning for technical skill basic life support acquisition in secondary school students. A randomized study.
Secondary ID [1] 288566 0
Nill know
Universal Trial Number (UTN)
Trial acronym
FACE (Feedback for Acquisition of ChEst compression)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac arrest 297691 0
Cardiopulmonary resuscitation (CPR) 297931 0
Basic Life Support - Defibrillation (BLSD) 297932 0
Condition category
Condition code
Cardiovascular 297870 297870 0 0
Other cardiovascular diseases
Public Health 297871 297871 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Students will be randomized into two groups: 1) Qcpr arm and 2) instructor arm. After a unique frontal lesson cycle from qualified instructors about cardiac arrest, Basic Life Support - Defibrillation (BLS-D) and high quality chest compression, students will be randomized. In the Qcpr group (Q) students will receieve feedback about their chest compression performance on resuscitation training mannequin by a computer-based feedback system (QCPR Registered Trademark, Laerdal, Norway) which analyses rate, depth, recoil and hand position. QCPR (Registered Trademark) is a software displaying parameters related to chest compression performance on a screen linked to the manneqiun. Students will receive also a global compression score taking into account all variables related to the quality of chest compression. In the instructor arm, students will receive feedback from a qualified instructor who will decide when the criteria for high quality standard chest compression will be reached.
All students will perform a 2-minute CPR trial. In the qcpr arm, an instructor will comment with every student his/her performance basing on the score from QCPR (Registered Trademark) system for a maximun time of 10 minutes. In the instructor arm, students will recevie feedback from the instructor basing on what the instructor have seen during the CPR trial for a maximun time of 10 minutes each.
The feedback from instructor will be delivered immediately after the CPR trial. The outcomes assessment will be performed in a separate 2-minute CPR trial with QCPR (Registered Trademark) system blinded to students and instructor 7 days later.
There is no planning for strategies to monitor adherence.
Intervention code [1] 293951 0
Other interventions
Comparator / control treatment
The control group will be exposed to standard feedback by qualified instructors.
Control group
Active

Outcomes
Primary outcome [1] 297396 0
Compression score which is an outcome of the Qcpr software taking into account all the variables associated with the quality of chest compression.
Timepoint [1] 297396 0
At seven days from standard lessons cycle and training.
Secondary outcome [1] 320960 0
Passing rate from a qualified instructor blinded to compression score
Timepoint [1] 320960 0
Seven days from standard lessons cycle and training
Secondary outcome [2] 321580 0
Subject overall satisfaction by 1-10 Likert scale from students
Timepoint [2] 321580 0
Seven days from standard lessons cycle and training
Secondary outcome [3] 321581 0
Mean depth and rate of compression from QCPR software
Timepoint [3] 321581 0
Seven days from standard lessons cycle and training
Secondary outcome [4] 321582 0
Proportion of students with an overall compression score of 60% from QCPR software
Timepoint [4] 321582 0
Seven days from standard lessons cycle and training

Eligibility
Key inclusion criteria
All attending students on 4 and 5 years of secondary school randomly selected among the schools that will accept the project.
Minimum age
16 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students who did not participate to the full training

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)
Sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/04/2016
Actual
5/05/2016
Date of last participant enrolment
Anticipated
Actual
5/05/2016
Date of last data collection
Anticipated
Actual
12/05/2016
Sample size
Target
142
Accrual to date
Final
142
Recruitment outside Australia
Country [1] 7598 0
Italy
State/province [1] 7598 0

Funding & Sponsors
Funding source category [1] 292915 0
University
Name [1] 292915 0
Universita degli Studi di Palermo
Country [1] 292915 0
Italy
Primary sponsor type
University
Name
Universita degli Studi di Palermo
Address
Via del vespro 129, 90133, Palermo. Italy.
Country
Italy
Secondary sponsor category [1] 291670 0
None
Name [1] 291670 0
Address [1] 291670 0
Country [1] 291670 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294422 0
Comitato Etico Palermo 1
Ethics committee address [1] 294422 0
Via del Vespro 129, 90127, Palermo, Italy
Ethics committee country [1] 294422 0
Italy
Date submitted for ethics approval [1] 294422 0
20/01/2016
Approval date [1] 294422 0
17/02/2016
Ethics approval number [1] 294422 0

Summary
Brief summary
The primary aim of the study is to evaluate the efficacy of a computerized feedback system connected to a manikin that provides a real-time assessment of quality of the chest compressions in students attending the 4th and 5th year of secondary school in terms of their technical ability.
Students will be subjected to lectures about the Cardiac arrest and BLS-D. They will be randomized into two groups. In the first group, students will perform cycles of two minutes of chest compressions guided by a computerized feedback system that will evaluate their performance. In the second group students will receive feedback about their chest compressions performance by a qualified instructor. After seven days all students will be evaluated by the execution of a single cycle of chest compressions with manikin and computer system. After the training phase investigators will submit to the participants a questionnaire that will assess the satisfaction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63638 0
Dr Andrea Cortegiani
Address 63638 0
Via del vespro 129, 90127, Palermo, Italy
Country 63638 0
Italy
Phone 63638 0
+393389559460
Fax 63638 0
Email 63638 0
[email protected]
Contact person for public queries
Name 63639 0
Dr Andrea Cortegiani
Address 63639 0
Via del vespro 129, 90127, Palermo, Italy
Country 63639 0
Italy
Phone 63639 0
+393389559460
Fax 63639 0
Email 63639 0
[email protected]
Contact person for scientific queries
Name 63640 0
Dr Andrea Cortegiani
Address 63640 0
Via del vespro 129, 90127, Palermo, Italy.
Country 63640 0
Italy
Phone 63640 0
+393389559460
Fax 63640 0
Email 63640 0
[email protected]

No information has been provided regarding IPD availability


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.