Spinal Cord Injuries, Spine Injury
Conditions
Keywords
spinal cord perfusion pressure, spinal cord injury, intraspinal pressure, spinal reactivity
Brief summary
Intraspinal pressure monitoring has been advanced as a potential technique for evaluating spinal cord perfusion after traumatic spinal cord injury. In this study, the investigators aim to validate the technique for insertion of a fiberoptic pressure monitoring device in the subarachnoid space at the site of injury for measurement of intraspinal pressure and spinal cord perfusion pressure. The primary objective of this study is to validate the methodology of invasive intraspinal pressure monitoring to derive parameters for optimal spinal cord perfusion pressure, spinal cord reserve capacity and spinal reactivity index using data obtained during the patient's stay in the intensive care unit. Secondary objectives of this study will be to a) evaluate the safety of invasive intraspinal pressure monitoring, b) prospectively evaluate the overall relationship between spinal cord perfusion pressure and functional outcomes in patients with acute traumatic spinal cord injury and c) evaluate the relationship between spinal cord perfusion pressure, motor evoked potentials and functional outcomes after incomplete spinal cord injury.
Interventions
PROCEDUREInsertion of Intraspinal pressure monitor
A fiberoptic pressure monitoring wire will be placed into the subarachnoid space at the site of traumatic spinal cord injury
Sponsors
Health Sciences Centre Foundation, Manitoba
University of Manitoba
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* • patients with acute traumatic spinal cord injury ASIA A, B or C * age between 18-70yrs
Exclusion criteria
* patients with central cord syndrome * patients presenting to hospital \>48hrs from time of spinal cord injury * patients unable to communicate in english language * pre-existing cognitive impairment * penetrating spinal cord injury * pre-existing neurodegenerative disorder involving brain or spinal cord * patients with concomitant injuries requiring emergent surgical intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Derivation of parameters for optimal spinal cord perfusion pressure using intraspinal pressure data | 1 year | Derivation of parameters for optimal spinal cord perfusion pressure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of the accuracy of probe placement in relation to the site of injury | 1 year | — |
| Measure the correlation between spinal cord perfusion pressure and the American Spinal Injury Association (ASIA) Impairment scale, Quality of Life Index and Spinal Cord Independence Measure score. | 1 year | — |
| Record rates of adverse events in patients having insertion of intraspinal pressure monitor | 1 year | Measure infection rates, rates of pseudomeningoceles, neurological injury, probe dislodgment, meningitis and or subdural hematoma at injury site. |
Countries
Canada
Contacts
Primary ContactPerry Dhaliwal, MD MPH
Backup ContactFrederick Zeiler, MD PhD
Outcome results
None listed