Intraspinal Pressure Monitoring for Acute Traumatic Spinal Cord Injury: A Validation Study

Study Overview
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Brief Summary
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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.

Official Title
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Intraspinal Pressure Monitoring for Acute Traumatic Spinal Cord Injury: A Validation Study

Conditions
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Spinal Cord Injuries, Spine Injury

Intervention / Treatment
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* Procedure: Insertion of Intraspinal pressure monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraspinal Pressure Monitoring<br>A fiberoptic pressure monitoring device will be placed into the subarachnoid space at the site of traumatic spinal cord injury | Procedure: Insertion of Intraspinal pressure monitor<br>* A fiberoptic pressure monitoring wire will be placed into the subarachnoid space at the site of traumatic spinal cord injury<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Derivation of parameters for optimal spinal cord perfusion pressure using intraspinal pressure data | Derivation of parameters for optimal spinal cord perfusion pressure. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measure infection rates, rates of pseudomeningoceles, neurological injury, probe dislodgment, meningitis and or subdural hematoma at injury site. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord perfusion pressure, spinal cord injury, intraspinal pressure, spinal reactivity