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Trial registered on ANZCTR


Registration number
ACTRN12616000687493
Ethics application status
Approved
Date submitted
19/05/2016
Date registered
26/05/2016
Date last updated
9/09/2019
Date data sharing statement initially provided
9/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective evaluation of a paramedic neurological assessment for spinal cord injury
Scientific title
Prospective evaluation of the SPinal Emergency Evaluation of Deficits (SPEED) paramedic neurological assessment for spinal cord injury
Secondary ID [1] 287585 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 296374 0
Condition category
Condition code
Neurological 296644 296644 0 0
Other neurological disorders
Injuries and Accidents 298164 298164 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The SPEED (SPinal Emergency Evaluation of Deficits) has been developed to determine whether a simple assessment of neurological function can rapidly determine the level and severity of cervical SCI. This assessment involves paramedics evaluating the participants' foot motor and sensory function (ability to feel light touch at the base of the heel) to indicate the severity of injury. C3 sensation will be assessed by light touch at the jugular notch, bilateral hand grip strength and spinal pain level will also be assessed to indicate whether injury is in the high cervical, low and mid cervical or thoracic regions. The assessment procedure is expected to take 2 minutes.
This project will apply the SPEED assessment to a prospective cohort of patients with suspected cervical SCI to validate this assessment tool.
Intervention code [1] 294197 0
Diagnosis / Prognosis
Comparator / control treatment
The SPEED score will be compared to the American Spinal Injury Association Impairment Scale (AIS) grade at each assessment time point
Control group
Active

Outcomes
Primary outcome [1] 297676 0
Agreement between the paramedic neurological assessment (SPEED) score and the AIS grade prior to surgery or within 24 hours post-injury.
Timepoint [1] 297676 0
Paramedic assessment less than or equal to 2 hours of injury
Prior to surgery or within 24 hours post-injury.
Secondary outcome [1] 321798 0
Agreement between the paramedic SPEED score and the hospital AIS grade within 3-7 days post-injury.
Timepoint [1] 321798 0
3-7 days post-injury
Secondary outcome [2] 321799 0
Agreement between the paramedic SPEED score and the hospital SPEED score within 24 hours post-injury or prior to decompressive surgery.
Timepoint [2] 321799 0
24 hours post-injury or prior to decompressive surgery.
Secondary outcome [3] 321800 0
Agreement between the paramedic SPEED score and the hospital SPEED score at 3-7 days post-injury.
Timepoint [3] 321800 0
3-7 days post-injury.

Eligibility
Key inclusion criteria
Assessed by paramedics within 2 hours of injury.
Suspected vertebral column injury (any level) with neurological deficits* due to possible SCI.
Admitted to participating hospitals within 24 hours post-injury.
*Neurological deficits defined as: any weakness, paralysis or change in sensation of one or more limbs reported by participant or found on examination.
Minimum age
15 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to follow commands due to significant head injury, drug or alcohol intoxication, mental or hearing impairment.
GCS < 13.
Suspected multiple traumatic injuries (defined as likely trauma to at least one other major organ, more than two long bone fractures, significant abdominal bleeding and head injury).
Immediate intubation needed.
Cardiac arrest at scene.
Known or obvious pregnancy.
Pre-injury major neurological deficits (e.g. stroke, Parkinson’s disease and Alzheimer’s disease).

Study design
Purpose of the study
Diagnosis
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Power calculations using Choen’s kappa require an estimation of the null value of kappa, the estimated kappa, the proportion of positive ratings, and required power. The null value of kappa would be around 0.6; below this the SPEED test would likely not be clinically useful. Based on the results of the retrospective SPEED study in Victoria, a kappa of 0.9 would be expected and the proportion of positive ratings between a motor score of 0 and an ASIA A or B score expected to be around 70%. From this data, a sample size of 66 is required for an 80% power to detect a 90 % agreement (kappa score) between a SPEED motor score of 0 and a pre-surgical ASIA score of A or B. To ensure availability of the required number of assessed patients, the sample size will be increased 70 to account for losses to follow-up.
Choen’s kappa will be used to determine the agreement between the SPEED and AIS grade.
To determine the ability of the field paramedic neurological assessment to predict participant’s ability to walk independently 6 months post-injury, receiver-operating-characteristics analysis will be utilised.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/10/2017
Actual
17/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
SA,WA,VIC
Recruitment hospital [1] 5717 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 5718 0
The Alfred - Prahran
Recruitment hospital [3] 5719 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 5720 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 5721 0
Royal Perth Hospital - Perth

Funding & Sponsors
Funding source category [1] 293119 0
Government body
Name [1] 293119 0
NHMRC
Country [1] 293119 0
Australia
Funding source category [2] 293120 0
Government body
Name [2] 293120 0
Institute for Safety, Compensation and Recovery Research (ISCRR)
Country [2] 293120 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Parkville, VIC 3010
Country
Australia
Secondary sponsor category [1] 291909 0
None
Name [1] 291909 0
Address [1] 291909 0
Country [1] 291909 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294617 0
Austin Health Human Research Committee
Ethics committee address [1] 294617 0
Ethics committee country [1] 294617 0
Australia
Date submitted for ethics approval [1] 294617 0
02/09/2015
Approval date [1] 294617 0
08/10/2015
Ethics approval number [1] 294617 0
15/364

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

Contacts
Principal investigator
Name 60758 0
Dr Peter Batchelor
Address 60758 0
Level 4, Clinical Sciences Building
Royal Parade (via Melbourne Private Hospital)
Parkville VIC 3050
Country 60758 0
Australia
Phone 60758 0
+61 3 8344 7958
Fax 60758 0
Email 60758 0
peter.batch@unimelb.edu.au
Contact person for public queries
Name 60759 0
Peta Skeers
Address 60759 0
Level 4, Clinical Sciences Building
Royal Parade (via Melbourne Private Hospital)
Parkville VIC 3050
Country 60759 0
Australia
Phone 60759 0
+61 3 9903 8654
Fax 60759 0
Email 60759 0
peta.skeers@unimelb.edu.au
Contact person for scientific queries
Name 60760 0
Peter Batchelor
Address 60760 0
Level 4, Clinical Sciences Building
Royal Parade (via Melbourne Private Hospital)
Parkville VIC 3050
Country 60760 0
Australia
Phone 60760 0
+61 3 8344 7958
Fax 60760 0
Email 60760 0
peter.batch@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.