Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000177651
Ethics application status
Approved
Date submitted
15/08/2005
Date registered
19/08/2005
Date last updated
19/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pre-hospital rapid sequence intubation in patients with severe head injury
Scientific title
The effects on outcome at 6 months of pre-hospital rapid sequence intubation compared with no intubation in patients with severe head injury.
Universal Trial Number (UTN)
Trial acronym
The RSI study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe traumatic brain injury 273 0
Condition category
Condition code
Injuries and Accidents 307 307 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment group receive rapid sequence intubation
Intervention code [1] 196 0
Treatment: Other
Comparator / control treatment
Control group receive basic airway care.
Control group
Active

Outcomes
Primary outcome [1] 362 0
Extended Glasgow Outcome Coma Score
Timepoint [1] 362 0
At 6 months.
Secondary outcome [1] 810 0
Hospital mortality
Timepoint [1] 810 0
Secondary outcome [2] 811 0
Hospital length of stay
Timepoint [2] 811 0
Secondary outcome [3] 812 0
Pre-hospital hypoxia
Timepoint [3] 812 0
Secondary outcome [4] 813 0
Pre-hospital scene time
Timepoint [4] 813 0
Secondary outcome [5] 814 0
Intubation failure
Timepoint [5] 814 0

Eligibility
Key inclusion criteria
Coma due to head injury, GCS<10, airway reflexes present.
Minimum age
17 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Require air transport, pregnancy, contra-indications to suxamthonium, <10 minutes to Emergency Department.

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)
opaque envelopes containing allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer random number
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 365 0
Government body
Name [1] 365 0
National Health and Medical Research Council
Country [1] 365 0
Australia
Funding source category [2] 366 0
Charities/Societies/Foundations
Name [2] 366 0
Victorian Trauma Foundation
Country [2] 366 0
Australia
Primary sponsor type
Other
Name
Metropolitan Ambulance Service
Address
Country
Australia
Secondary sponsor category [1] 289 0
Other
Name [1] 289 0
Rural Ambulance Victoria
Address [1] 289 0
Country [1] 289 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1339 0
Alfred Hospital
Ethics committee address [1] 1339 0
Ethics committee country [1] 1339 0
Australia
Date submitted for ethics approval [1] 1339 0
Approval date [1] 1339 0
Ethics approval number [1] 1339 0
Ethics committee name [2] 1340 0
Southern Health
Ethics committee address [2] 1340 0
Ethics committee country [2] 1340 0
Australia
Date submitted for ethics approval [2] 1340 0
Approval date [2] 1340 0
Ethics approval number [2] 1340 0
Ethics committee name [3] 1341 0
Austin Hospital
Ethics committee address [3] 1341 0
Ethics committee country [3] 1341 0
Australia
Date submitted for ethics approval [3] 1341 0
Approval date [3] 1341 0
Ethics approval number [3] 1341 0
Ethics committee name [4] 1342 0
eastern Health
Ethics committee address [4] 1342 0
Ethics committee country [4] 1342 0
Australia
Date submitted for ethics approval [4] 1342 0
Approval date [4] 1342 0
Ethics approval number [4] 1342 0
Ethics committee name [5] 1343 0
Melbourne Health
Ethics committee address [5] 1343 0
Ethics committee country [5] 1343 0
Australia
Date submitted for ethics approval [5] 1343 0
Approval date [5] 1343 0
Ethics approval number [5] 1343 0
Ethics committee name [6] 1344 0
Peninsula Health
Ethics committee address [6] 1344 0
Ethics committee country [6] 1344 0
Australia
Date submitted for ethics approval [6] 1344 0
Approval date [6] 1344 0
Ethics approval number [6] 1344 0
Ethics committee name [7] 1345 0
Geelong Hospital
Ethics committee address [7] 1345 0
Ethics committee country [7] 1345 0
Australia
Date submitted for ethics approval [7] 1345 0
Approval date [7] 1345 0
Ethics approval number [7] 1345 0
Ethics committee name [8] 1346 0
Ballarat Hospital
Ethics committee address [8] 1346 0
Ethics committee country [8] 1346 0
Australia
Date submitted for ethics approval [8] 1346 0
Approval date [8] 1346 0
Ethics approval number [8] 1346 0
Ethics committee name [9] 1347 0
Bendigo Hospital
Ethics committee address [9] 1347 0
Ethics committee country [9] 1347 0
Australia
Date submitted for ethics approval [9] 1347 0
Approval date [9] 1347 0
Ethics approval number [9] 1347 0

Summary
Brief summary
This study will determine whether paramedic intubation at the scene improves outcomes compared with intubation at the hospital in patients with severe head injury
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35588 0
Address 35588 0
Country 35588 0
Phone 35588 0
Fax 35588 0
Email 35588 0
Contact person for public queries
Name 9385 0
Dr Stephen Bernard
Address 9385 0
Central and Eastern Clinical School
Alfred Hospital
Commercial Rd
Melbourne VIC 3004
Country 9385 0
Australia
Phone 9385 0
+61 419303737
Fax 9385 0
Email 9385 0
[email protected]
Contact person for scientific queries
Name 313 0
Dr Stephen Bernard
Address 313 0
Central and Eastern Clinical School
Alfred Hospital
Commercial Rd
Melbourne VIC 3004
Country 313 0
Australia
Phone 313 0
+61 419303737
Fax 313 0
Email 313 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.