An interventional study of Insertion of Intraspinal pressure monitor in Spinal Cord Injuries and Spine Injury, sponsored by University of Manitoba. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by University of Manitoba · Not applicable, Interventional, and Other
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.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 20 is below the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University of Manitoba is the lead sponsor of 555 studies on the registry; 89 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
patients with acute traumatic spinal cord injury ASIA A, B or C
Exclusion Criteria:
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
A fiberoptic pressure monitoring wire will be placed into the subarachnoid space at the site of traumatic spinal cord injury
Derivation of parameters for optimal spinal cord perfusion pressure using intraspinal pressure data
Derivation of parameters for optimal spinal cord perfusion pressure.
Time frame: 1 year
Measurement of the accuracy of probe placement in relation to the site of injury
Time frame: 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.
Time frame: 1 year
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.
Time frame: 1 year
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.