Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04550117
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2020-06-24
Brief Title:
Intraspinal Pressure Monitoring for Acute Traumatic Spinal Cord Injury A Validation Study
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Intraspinal Pressure Monitoring for Acute Traumatic Spinal Cord Injury A Validation Study
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None