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

University of Manitoba

Status: Enrolling

Conditions: Spinal Cord Injuries; Spine Injury

Treatments: Procedure: Insertion of Intraspinal pressure monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT04550117

HS23117 9B2019:075)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Intraspinal Pressure Monitoring

Experimental group

Description:

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

Treatment:

Procedure: Insertion of Intraspinal pressure monitor