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

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries; Spine Injury
• Interventions: Procedure: Insertion of Intraspinal pressure monitor

• Registration Number: NCT04550117
• Lead Sponsor: University of Manitoba

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-23
• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-16
• Status Verified: 2023-12
• Last Update Submitted: 2024-05-27
• Last Update Posted: 2024-05-29
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraspinal Pressure Monitoring	Insertion of Intraspinal pressure monitor	A fiberoptic pressure monitoring device will be placed into the subarachnoid space at the site of traumatic spinal cord injury

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada