NCT04550117

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Cord Injuries
• Spine Injury

Interventions

Type	Name	Description
PROCEDURE	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

Timeline

• Start date: 2020-06-23
• Primary completion: 2025-10-31
• Completion: 2025-12-31
• First posted: 2020-09-16
• Last updated: 2024-05-29

Locations

1 site across 1 country: Canada