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

NCT04550117 | Unknown

• 1 other identifier: HS23117 9B2019:075)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Spine Injury

Keywords

spinal cord perfusion pressure; spinal cord injury; intraspinal pressure; spinal reactivity

Outcome Measures

Primary Outcomes (1)

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

  Derivation of parameters for optimal spinal cord perfusion pressure.

  1 year

Secondary Outcomes (3)

• 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

Study Arms (1)

Intraspinal Pressure Monitoring

EXPERIMENTAL

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

Procedure: Insertion of Intraspinal pressure monitor

Interventions

Insertion of Intraspinal pressure monitor PROCEDURE

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

Intraspinal Pressure Monitoring

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with acute traumatic spinal cord injury ASIA A, B or C
• age between 18-70yrs

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• Health Sciences Centre Foundation, Manitoba: collaborator

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3A1R9, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 36126069 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Back Injuries

Central Study Contacts

Perry Dhaliwal, MD MPH

CONTACT

2047877227; pdhaliwal@exchange.hsc.mb.ca

Frederick Zeiler, MD PhD

CONTACT

2047877227; frederick.zeiler@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurosurgery

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: September 16, 2020
• Study Start: June 23, 2020
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 29, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)