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

NCT ID: NCT04550117

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-23

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Spinal Cord Injuries Spine Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intraspinal Pressure Monitoring

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

Group Type EXPERIMENTAL

Insertion of Intraspinal pressure monitor

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Health Sciences Centre Foundation, Manitoba

OTHER

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Perry Dhaliwal

Assistant Professor of Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Health Sciences Centre

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Perry Dhaliwal, MD MPH

Role: CONTACT

2047877227

Frederick Zeiler, MD PhD

Role: CONTACT

2047877227

Facility Contacts

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Perry Dhaliwal, MD MPH

Role: primary

2047877227

Frederick Zeiler, MD PhD

Role: backup

2047877227

References

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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.

Reference Type DERIVED
PMID: 36126069 (View on PubMed)

Other Identifiers

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HS23117 9B2019:075)

Identifier Type: -

Identifier Source: org_study_id

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