Intraspinal Pressure Monitoring for Acute Traumatic Spinal Cord Injury: A Validation Study
NCT ID: NCT04550117
Last Updated: 2024-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2020-06-23
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Intraspinal Pressure Monitoring
A fiberoptic pressure monitoring device will be placed into the subarachnoid space at the site of traumatic spinal cord injury
Insertion of Intraspinal pressure monitor
A fiberoptic pressure monitoring wire will be placed into the subarachnoid space at the site of traumatic spinal cord injury
Interventions
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Insertion of Intraspinal pressure monitor
A fiberoptic pressure monitoring wire will be placed into the subarachnoid space at the site of traumatic spinal cord injury
Eligibility Criteria
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Inclusion Criteria
* age between 18-70yrs
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Health Sciences Centre Foundation, Manitoba
OTHER
University of Manitoba
OTHER
Responsible Party
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Perry Dhaliwal
Assistant Professor of Neurosurgery
Locations
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Health Sciences Centre
Winnipeg, Manitoba, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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HS23117 9B2019:075)
Identifier Type: -
Identifier Source: org_study_id
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