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

Primary Purpose

Spinal Cord Injuries, Spine Injury

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Insertion of Intraspinal pressure monitor
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Cord Injuries focused on measuring spinal cord perfusion pressure, spinal cord injury, intraspinal pressure, spinal reactivity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intraspinal Pressure Monitoring

Arm Description

A fiberoptic pressure monitoring device will be placed into the subarachnoid space at the site of traumatic spinal cord injury

Outcomes

Primary Outcome Measures

Derivation of parameters for optimal spinal cord perfusion pressure using intraspinal pressure data
Derivation of parameters for optimal spinal cord perfusion pressure.

Secondary Outcome Measures

Measurement of the accuracy of probe placement in relation to the site of injury
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.
Record rates of adverse events in patients having insertion of intraspinal pressure monitor
Measure infection rates, rates of pseudomeningoceles, neurological injury, probe dislodgment, meningitis and or subdural hematoma at injury site.

Full Information

First Posted
June 24, 2020
Last Updated
June 10, 2022
Sponsor
University of Manitoba
Collaborators
Health Sciences Centre Foundation, Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT04550117
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2020 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
Health Sciences Centre Foundation, Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Spine Injury
Keywords
spinal cord perfusion pressure, spinal cord injury, intraspinal pressure, spinal reactivity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intraspinal Pressure Monitoring
Arm Type
Experimental
Arm Description
A fiberoptic pressure monitoring device will be placed into the subarachnoid space at the site of traumatic spinal cord injury
Intervention Type
Procedure
Intervention Name(s)
Insertion of Intraspinal pressure monitor
Intervention Description
A fiberoptic pressure monitoring wire will be placed into the subarachnoid space at the site of traumatic spinal cord injury
Primary Outcome Measure Information:
Title
Derivation of parameters for optimal spinal cord perfusion pressure using intraspinal pressure data
Description
Derivation of parameters for optimal spinal cord perfusion pressure.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Measurement of the accuracy of probe placement in relation to the site of injury
Time Frame
1 year
Title
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.
Time Frame
1 year
Title
Record rates of adverse events in patients having insertion of intraspinal pressure monitor
Description
Measure infection rates, rates of pseudomeningoceles, neurological injury, probe dislodgment, meningitis and or subdural hematoma at injury site.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Perry Dhaliwal, MD MPH
Phone
2047877227
Email
pdhaliwal@exchange.hsc.mb.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Frederick Zeiler, MD PhD
Phone
2047877227
Email
frederick.zeiler@umanitoba.ca
Facility Information:
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A1R9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Perry Dhaliwal, MD MPH
Phone
2047877227
Email
pdhaliwal@exchange.hsc.mb.ca
First Name & Middle Initial & Last Name & Degree
Frederick Zeiler, MD PhD
Phone
2047877227
Email
frederick.zeiler@umanitoba.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36126069
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.
Results Reference
derived

Learn more about this trial

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

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