Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001191482
Ethics application status
Approved
Date submitted
20/08/2016
Date registered
30/08/2016
Date last updated
10/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of the Zap and Run defibrillator skills training program for health care workers.
Scientific title
Efficacy of the Zap and Run defibrillator skills training program for health care workers.
Secondary ID [1] 289977 0
None
Universal Trial Number (UTN)
U1111-1186-6710
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Defibrillator use by health care workers. 299983 0
Condition category
Condition code
Public Health 299876 299876 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a fifteen minute one to one training workshop. It uses a simulated defibrillator [ALSi] to practice skills involved in rhythm recognition, defibrillation, cardioversion and pacing. All trainers are experience critical care physicians who record adherence to ALS guidelines using a data sheet and the logging function of the simulator.
Intervention code [1] 295673 0
Treatment: Other
Comparator / control treatment
There is no separate control group. The methodology is within group analysis of measures undertaken during the workshop to determine skill levels and acceptability of the training.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299353 0
Number of errors in treatment detected by the trainer using a checklist comparing treatment to ALS guidelines while observing the performance of the participant on the ALSi simulator.
Timepoint [1] 299353 0
Testing occurs during the workshop with coaching after the test is undertaken.
Secondary outcome [1] 326907 0
Time to complete critical tasks is measured by the ALSi simulator during the training session.
Timepoint [1] 326907 0
Testing occurs during the workshop with coaching after the test is undertaken.
Secondary outcome [2] 327230 0
Participants will be asked to evaluate the workshop using a five point Likert scale to assess perceived ease and usefulness of training.
Timepoint [2] 327230 0
Testing occurs during the workshop with coaching after the test is undertaken.

Eligibility
Key inclusion criteria
Critical care and anaesthesia medical and nursing staff
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non English speaking

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics of baseline performance and nonparametric comparisons of before after measures. The target of 100 participants was chosen as a sample of convenience to provide information on medical and nursing staff.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
31/03/2016
Date of last participant enrolment
Anticipated
31/12/2016
Actual
11/11/2016
Date of last data collection
Anticipated
31/08/2017
Actual
11/11/2016
Sample size
Target
100
Accrual to date
Final
81
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6508 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 14072 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 294350 0
Hospital
Name [1] 294350 0
St George Hospital Department of Anaesthesia
Country [1] 294350 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia, St. George Hospital
Address
Gray St. Kogarah NSW 2217
Country
Australia
Secondary sponsor category [1] 293188 0
None
Name [1] 293188 0
Address [1] 293188 0
Country [1] 293188 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295767 0
South Eastern Sydney LHD Human Research Ethics Committee
Ethics committee address [1] 295767 0
Ethics committee country [1] 295767 0
Australia
Date submitted for ethics approval [1] 295767 0
23/02/2016
Approval date [1] 295767 0
23/03/2016
Ethics approval number [1] 295767 0
16/067 [LNR/16/POWH/131]

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

Contacts
Principal investigator
Name 68406 0
A/Prof Richard Morris
Address 68406 0
Department of Anaesthesia
St. George Hospital
Gray St. Kogarah
NSW 2217
Country 68406 0
Australia
Phone 68406 0
+61 2 9113 2100
Fax 68406 0
Email 68406 0
[email protected]
Contact person for public queries
Name 68407 0
Richard Morris
Address 68407 0
Department of Anaesthesia
St. George Hospital
Gray St. Kogarah
NSW 2217
Country 68407 0
Australia
Phone 68407 0
+61 2 9113 2100
Fax 68407 0
Email 68407 0
[email protected]
Contact person for scientific queries
Name 68408 0
Richard Morris
Address 68408 0
Department of Anaesthesia
St. George Hospital
Gray St. Kogarah
NSW 2217
Country 68408 0
Australia
Phone 68408 0
+61 2 9113 2100
Fax 68408 0
Email 68408 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.