Clinical trial NCT04550117: Intraspinal Pressure Monitoring for Acute Traumatic Spinal Cord Injury: A Validation Study
Official title: Intraspinal Pressure Monitoring for Acute Traumatic Spinal Cord Injury: A Validation Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Spine Injury
Keywords: spinal cord perfusion pressure
spinal cord injury
intraspinal pressure
spinal reactivity
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Health Sciences Centre Foundation, Manitoba
First posted: 2020-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Derivation of parameters for optimal spinal cord perfusion pressure using intraspinal pressure data
timeFrame: 1 year
Secondary outcomes:
measure: Measurement of the accuracy of probe placement in relation to the site of injury
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
measure: Record rates of adverse events in patients having insertion of intraspinal pressure monitor
timeFrame: 1 year
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
References:
citation: Dhaliwal P, Wilkinson M, Zeiler FA. The Winnipeg Intraspinal Pressure Monitoring Study (WISP): A protocol for validation of fiberoptic pressure monitoring for acute traumatic spinal cord injury. PLoS One. 2022 Sep 20;17(9):e0263499. doi: 10.1371/journal.pone.0263499. eCollection 2022.