None listed
Conditions
Brief summary
In young patients, traumatic injury to the cervical spinal cord generally results from vertebral fracture and dislocation of vertebra, with injury to the spinal cord occurring not just at the time of impact, but also from compression of the spinal cord as a consequence of the displaced vertebra. Traumatic central cord syndrome differs from traumatic SCI in that the general mechanism is hyper-extension of the spine, causing acute severe canal restriction, in a patient with pre-existing narrowing of the cervical canal. Compression of the spinal cord as a result of canal stenosis and cord swelling usually occurs soon after injury. Animal and preliminary human data demonstrate that urgent relief of compression appears to greatly improve outcome. However, urgent decompression in humans is difficult to achieve because of the time occupied by transportation, investigation, and stabilisation of the patient as well as the organisation of surgery. Pre-clinical data demonstrate that hypothermia can suspend the progressive damage caused to the spinal cord by compression thereby allowing decompressive surgery to be performed in a clinically achievable time frame (Batchelor et al. 2010). The primary purpose of the ICED study is to determine whether the combination of hypothermia and early decompression is able to improve outcomes in patients with severe spinal cord injuries of the neck. Selected patients will be cooled by paramedics or emergency physicians immediately following injury and then rapidly transported to theatre to undergo surgical decompression and stabilisation of the spinal cord. Cooling will be maintained for 24 hours and then patients will be slowly rewarmed and monitored over the next 72 hours. The ICED safety and feasibility study will determine whether it is possible to cool patients with spinal cord injuries resulting from vertebral trauma in the neck in the first hours after injury. This study will also determine whether it is feasible to operate on patients very early after injury. As well as determining whether these interventions can be performed, the incidence and severity of complications will be monitored to determine whether these interventions are safe.
Interventions
Patients with cervical spinal cord injury (SCI) will be cooled by paramedics using ice-cold intravenous saline to a target core temperature of 33-34 degrees Celsius. Cooling will be continued in hospital using an intravascular cooling catheter (or surface temperature management system) set to maintain the target temperature of 33-34 degrees Celsius. The cooling method selected in hospital will be chosen at the discretion of the treating physician.
Patients will be maintained at the target tempe
Patients with cervical spinal cord injury (SCI) will be cooled by paramedics using ice-cold intravenous saline to a target core temperature of 33-34 degrees Celsius. Cooling will be continued in hospital using an intravascular cooling catheter (or surface temperature management system) set to maintain the target temperature of 33-34 degrees Celsius. The cooling method selected in hospital will be chosen at the discretion of the treating physician. Patients will be maintained at the target temperature (33.0-34.0 degrees Celsius) for 24 hours post-treatment initiation and then slowly rewarmed to 36 degrees Celsius over 12 hours. Controlled temperature management (36-37 degrees Celsius) will be continued for a further 72 hours. Patients enrolled in the trial will be admitted to the Intensive Care Unit (ICU) and core temperature recorded hourly across the period of therapy. Measures to control core temperature will be documented, including volume and duration of ice-cold saline infused, temperature management system selected, intensity and duration of temperature control and use of passive surface cooling measures. Patients will also undergo decompression surgery as appropriate within 8 hours of injury for cervical fracture and/or dislocation injuries, and within 18 hours of injury for acute central cord syndrome. The aim of decompression will be to restore the spinal canal diameter to normal by reducing the dislocated vertebrae and removal of bone fragments, disc and other material. decision of whether surgery is required, Specifics including the number of levels decompressed, approach (anterior vs. posterior) and use of instrumentation will be left to the treating orthopaedic surgeons and/or neurosurgeons. Procedure duration averages between 2 and 4 hours and varies depending upon the extent of injury.
Sponsors
The University of Melbourne
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Cervical vertebral column trauma Less than 2 hours post-injury Able to participate in the Spinal Emergency Evaluation of Deficits (SPEED) neurological assessment Neurological deficits in all 4 limbs: Flicker or no ankle or toe movement bilaterally (SPEED motor score of 0-2) and weak or no hand grip on SPEED neurological assessment Planned transport to the participating study hospital Additional criterion for potential central cord syndrome patients: Less than 4 hours post-injury with definite foot movement (SPEED motor of 2-4), weak or no hand movement and American Spinal Injury Association Impairment Scale (AIS) motor examination score less than or equal to 50/100
Exclusion criteria
Unable to commence induction of hypothermia within 2 hours post-injury (or within 4 hours post-injury for central cord syndrome patients) Unable to follow commands due to significant head injury, drug or alcohol intoxication, mental or hearing impairment Glasgow coma score <13 Suspected multiple traumatic injuries with significant blood loss (due to likely trauma to the chest, abdomen, pelvis or long bone fractures) Known or obvious pregnancy Cardiac arrest at scene Pre-injury major neurological deficit (e.g. stroke, Parkinson’s disease or dementia)
Outcome results
None listed