Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000401459
Ethics application status
Approved
Date submitted
27/05/2007
Date registered
6/08/2007
Date last updated
6/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is 3 minutes of CPR before defibrillation, better than immediate defibrillation, for patients who are found to be in cardiac arrests by paramedics?
Scientific title
In patients who are found by paramedics to be in cardiac arrests due to Ventricular Fibrillation, is 3 minutes of Cardiopulmonary Resuscitation before defibrillation superior to immediate defibrillation when examining survival to hospital discharge.
Universal Trial Number (UTN)
Trial acronym
CBD Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac arrest, ventricular fibrillation 2182 0
Condition category
Condition code
Cardiovascular 2277 2277 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following the first defibrillation standard cardiac arrest guidelines are reverted to. The duration of study is until either death is declared on scene, death occurs in hospital or the patient survives to hospital discharge.
Intervention code [1] 1785 0
Treatment: Other
Comparator / control treatment
The control of immediate defibrillation is being compared to an intervention of 3 minute of cardiopulmonary resuscitation before defibrillation.
Control group
Active

Outcomes
Primary outcome [1] 3165 0
Survival to hospital discharge
Timepoint [1] 3165 0
Secondary outcome [1] 5280 0
Neurological status
Timepoint [1] 5280 0
At discharge
Secondary outcome [2] 5281 0
Return of spontaneous circulation
Timepoint [2] 5281 0
At any point during the resuscitation.

Eligibility
Key inclusion criteria
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiac arrest due to trauma, witnessed cardiac arrest, clinical intervention (intubation or drugs) applied before arrival of paramedics (bystander CPR is not exclusion criteria), not for resuscitation order or similar documentation/wishesinclusion: out-of-hospital cardiac arrest found to be in ventricular fibrillation by the first paramedics on scene.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
RCT: patient randomised by paramedics opening a sealed envelope on-scene
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The patients, who are in cardiac arrest, are blinded to the treatment as are the hospital medical officers who report on the patient outcomes (i.e. survival to hospital discharge, neurological function at discharge or death in hospital). The paramedics who perform the resuscitation cannot be blinded to the treatment. Additionally, the individuals analysing the data are not blinded to the treatment group.
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2443 0
Other
Name [1] 2443 0
South Australia Ambulance Service
Country [1] 2443 0
Australia
Primary sponsor type
Other
Name
South Australia Ambulance Service
Address
Country
Australia
Secondary sponsor category [1] 2214 0
Other
Name [1] 2214 0
South Australia Ambulance Service
Address [1] 2214 0
Country [1] 2214 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4293 0
Department of Health, SA
Ethics committee address [1] 4293 0
Ethics committee country [1] 4293 0
Australia
Date submitted for ethics approval [1] 4293 0
Approval date [1] 4293 0
Ethics approval number [1] 4293 0
Ethics committee name [2] 4294 0
Royal Adelaide Hospital
Ethics committee address [2] 4294 0
Ethics committee country [2] 4294 0
Australia
Date submitted for ethics approval [2] 4294 0
Approval date [2] 4294 0
Ethics approval number [2] 4294 0
Ethics committee name [3] 4295 0
Flinders Medical Centre
Ethics committee address [3] 4295 0
Ethics committee country [3] 4295 0
Australia
Date submitted for ethics approval [3] 4295 0
Approval date [3] 4295 0
Ethics approval number [3] 4295 0
Ethics committee name [4] 4296 0
Queen Elizabeth Hospital/Lyell McEwin Hospital
Ethics committee address [4] 4296 0
Ethics committee country [4] 4296 0
Australia
Date submitted for ethics approval [4] 4296 0
Approval date [4] 4296 0
Ethics approval number [4] 4296 0
Ethics committee name [5] 4297 0
Modbury Hospital
Ethics committee address [5] 4297 0
Ethics committee country [5] 4297 0
Australia
Date submitted for ethics approval [5] 4297 0
Approval date [5] 4297 0
Ethics approval number [5] 4297 0

Summary
Brief summary
The primary aim of the study is to determine whether 3 minutes of CPR before defibrillation is more effective than the standard procedure of immediate defibrillation in helping patient who are in cardiac arrest in the out-of-hospital environment to survive to hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27888 0
Address 27888 0
Country 27888 0
Phone 27888 0
Fax 27888 0
Email 27888 0
Contact person for public queries
Name 10974 0
Dr Paul Baker
Address 10974 0
South Australian Ambulance Service
216 Greenhill Road
Adelaide SA
Country 10974 0
Australia
Phone 10974 0
0422642277
Fax 10974 0
Email 10974 0
[email protected]
Contact person for scientific queries
Name 1902 0
Dr Paul Baker
Address 1902 0
South Australian Ambulance Service
216 Greenhill Road
Adelaide SA
Country 1902 0
Australia
Phone 1902 0
0422642277
Fax 1902 0
Email 1902 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.