Spinal Deformity Intraoperative Monitoring (SDIM)
Research type
Research Study
Full title
Spinal Deformity Intraoperative Monitoring (SDIM)
IRAS ID
260979
Contact name
Nasir A. Quraishi
Contact email
Sponsor organisation
AOSpine International
Duration of Study in the UK
2 years, 4 months, 30 days
Research summary
RESEARCH SUMMARY:
A multicenter, international prospectively collected patient cohort undergoing high-risk spinal cord level surgery or spinal osteotomy procedures will be enrolled to establish the incidence of intraoperative alerts in high-risk spinal cord cases, and explore factors associated with mitigating injury. Baseline, intraoperative, and postoperative characteristics, including demographics, radiological features, lower extremity motor score (LEMS), procedure, anesthetic agents used, and baseline blood pressure will be recorded for either adult patients or pediatric patients.
If a major change occurs in the intraoperative neuromonitoring, defined as a loss of amplitude greater than 50% in the MEP or SSEP from baseline or sustained EMG activity, a separate form (Appendix 3, Intraoperative Alert Form) will be completed in real-time by the neuromonitoring technician outlining the timing of the alert, blood pressure at the time, surgical events at the time of the change, intraoperative maneuvers performed to address the change, and resultant outcome of these maneuvers to address the neuromonitoring change. For each alert occurring during the procedure, a separate form will be completed.
Once the patient is awake from anesthesia, the treating surgeon will perform a neurological examination to identify details about the deficit including sidedness, LEMS, sensory deficit, injury to the nerve root, incomplete spinal cord (ie anterior cord, posterior cord, central cord, Brown-Sequard), complete spinal cord injury, conus or cauda equina deficit. The examination is repeated on the day of discharge from hospital, or at day 30, whichever comes first and documented in the corresponding form.
The objective of this study is to identify the incidence of intraoperative alerts in high-risk spinal cord cases, correlate significant neuromonitoring changes to intraoperative events, and identify maneuvers that will restore the neuromonitoring changes to baseline. The information provided by this study will educate spinal surgeons to recognize a spinal cord at risk and to perform intraoperative maneuvers that will decrease the incidence of neurological injuries.LAY SUMMARY OF RESULTS:
When using three IONM modalities in high-risk spine deformity surgeries, the incidence of IONM alerts was 15%. MEP signal loss was the most common signal loss. Surgical cause was the leading preceding event. Elevating blood pressure and anesthesia adjustment were the main maneuvers in response to an alert. The incidence of postoperative de novo neurological deficits was 11.2%.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
19/WM/0055
Date of REC Opinion
13 Jul 2019
REC opinion
Further Information Favourable Opinion