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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04550117
• Other study ID #: HS23117 9B2019:075)
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2022
• Source: University of Manitoba
• Contact: Perry Dhaliwal, MD MPH
• Phone: 2047877227
• Email: pdhaliwal[@]exchange.hsc.mb.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spine Injury
• Wounds and Injuries

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Health Sciences Centre Foundation, Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measurement of the accuracy of probe placement in relation to the site of injury		1 year
Secondary	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
Secondary	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.	1 year