Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-25 @ 8:25 PM
Study NCT ID:
NCT06712069
Status:
COMPLETED
Last Update Posted:
2025-01-20
First Post:
2024-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating MIONM Effectiveness in Predicting Postoperative Neurological Deficits Using Combined Modalities
Sponsor:
Alexandria University
Organization:
Study Overview
Official Title:
The Usefulness of Multimodal Intraoperative Neurophysiologic Monitoring During Brain or Spine Surgeries
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIONM
Brief Summary:
Objective: This study aimed to integrate findings from spinal and cranial surgeries with existing literature, emphasizing the role of Intraoperative Neurophysiological Monitoring (IONM) in improving surgical outcomes through best practices.
Methodology: Multimodal IONM, including motor evoked potential (MEP), somatosensory evoked potential (SSEP), and electromyography (EMG), was utilized in surgeries at Duke University Hospitals. Challenges included a small sample size and limited access to medical records.
Findings:
Effectiveness of IONM: High sensitivity (97.73%), specificity (83.33%), and predictive value of multimodal IONM confirmed its role in detecting intraoperative neurological injuries and optimizing outcomes.
Demographics: Analysis of 50 cases (58% male, aged 13-67 years) revealed demographic influences on surgical challenges and outcomes.
IONM Alerts: A 50% reduction in MEP/SSEP amplitudes was a critical criterion, with reversible alerts accounting for 70%, emphasizing the dynamic nature of neural responses.
Alert Causes \& Management: Excessive dissection was a common cause of alerts. Interventions like warm saline irrigation and surgical pauses mitigated risks.
Outcome Associations: Most patients (88%) experienced no new postoperative deficits, with significant associations between alert reversibility and deficit occurrence.
Statistical Insights:
Predictive Value: Strong correlations were observed between alert patterns and postoperative outcomes, with SSEP/MEP alerts reliably predicting neurological deficits.
Technology \& Resources: Modern devices, updated technology, and skilled staff were critical for high-quality results, highlighting the adage that "poor monitoring is worse than no monitoring."
Contextual Observations:
Heterogeneity of Cases: Diagnoses ranged from cervical intramedullary tumors to lumbar canal stenosis, requiring tailored interventions.
EMG Utility: EMG showed stability with fewer alerts, proving beneficial in specific surgeries.
Corrective Measures: Adjustments in mean arterial blood pressure and steroid use showcased adaptive intraoperative strategies.
Protocol Gaps: The absence of standardized IONM alert response protocols was noted, underscoring the need for future research.
Methodology: Multimodal IONM, including motor evoked potential (MEP), somatosensory evoked potential (SSEP), and electromyography (EMG), was utilized in surgeries at Duke University Hospitals. Challenges included a small sample size and limited access to medical records.
Findings:
Effectiveness of IONM: High sensitivity (97.73%), specificity (83.33%), and predictive value of multimodal IONM confirmed its role in detecting intraoperative neurological injuries and optimizing outcomes.
Demographics: Analysis of 50 cases (58% male, aged 13-67 years) revealed demographic influences on surgical challenges and outcomes.
IONM Alerts: A 50% reduction in MEP/SSEP amplitudes was a critical criterion, with reversible alerts accounting for 70%, emphasizing the dynamic nature of neural responses.
Alert Causes \& Management: Excessive dissection was a common cause of alerts. Interventions like warm saline irrigation and surgical pauses mitigated risks.
Outcome Associations: Most patients (88%) experienced no new postoperative deficits, with significant associations between alert reversibility and deficit occurrence.
Statistical Insights:
Predictive Value: Strong correlations were observed between alert patterns and postoperative outcomes, with SSEP/MEP alerts reliably predicting neurological deficits.
Technology \& Resources: Modern devices, updated technology, and skilled staff were critical for high-quality results, highlighting the adage that "poor monitoring is worse than no monitoring."
Contextual Observations:
Heterogeneity of Cases: Diagnoses ranged from cervical intramedullary tumors to lumbar canal stenosis, requiring tailored interventions.
EMG Utility: EMG showed stability with fewer alerts, proving beneficial in specific surgeries.
Corrective Measures: Adjustments in mean arterial blood pressure and steroid use showcased adaptive intraoperative strategies.
Protocol Gaps: The absence of standardized IONM alert response protocols was noted, underscoring the need for future research.
Detailed Description:
Detailed Description:
The discussion emphasizes the importance of intraoperative neurophysiological monitoring (IONM) in enhancing surgical safety during spinal and cranial procedures. Multimodal IONM (MIONM), incorporating somatosensory evoked potentials (SSEP), motor evoked potentials (MEP), and electromyography (EMG), serves as a critical tool for real-time neurological monitoring during these complex operations.
MIONM is highlighted for its ability to detect intraoperative neurological changes, enabling timely interventions. Factors such as patient demographics and case heterogeneity, including diverse diagnoses like craniotomy, lumbar canal stenosis, scoliosis, and cervical intramedullary tumors, underscore the need for tailored surgical approaches. The integration of modern equipment and experienced personnel ensures the delivery of high-quality monitoring results.
The discussion also explores the challenges in managing IONM alerts, including causes like over-dissection, hypoperfusion, and excessive cord manipulation. A multimodal approach to handling alerts includes interventions such as positional adjustments, warm saline irrigation, and optimizing blood flow. The absence of standardized protocols for responding to alerts highlights the need for future research to develop evidence-based guidelines.
Further research is encouraged to refine IONM methodologies, customize surgical strategies based on patient-specific factors, and establish standardized alert response protocols to optimize outcomes in spinal and cranial surgeries.
The discussion emphasizes the importance of intraoperative neurophysiological monitoring (IONM) in enhancing surgical safety during spinal and cranial procedures. Multimodal IONM (MIONM), incorporating somatosensory evoked potentials (SSEP), motor evoked potentials (MEP), and electromyography (EMG), serves as a critical tool for real-time neurological monitoring during these complex operations.
MIONM is highlighted for its ability to detect intraoperative neurological changes, enabling timely interventions. Factors such as patient demographics and case heterogeneity, including diverse diagnoses like craniotomy, lumbar canal stenosis, scoliosis, and cervical intramedullary tumors, underscore the need for tailored surgical approaches. The integration of modern equipment and experienced personnel ensures the delivery of high-quality monitoring results.
The discussion also explores the challenges in managing IONM alerts, including causes like over-dissection, hypoperfusion, and excessive cord manipulation. A multimodal approach to handling alerts includes interventions such as positional adjustments, warm saline irrigation, and optimizing blood flow. The absence of standardized protocols for responding to alerts highlights the need for future research to develop evidence-based guidelines.
Further research is encouraged to refine IONM methodologies, customize surgical strategies based on patient-specific factors, and establish standardized alert response protocols to optimize outcomes in spinal and cranial surgeries.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Assistant Lecturer of PMR | REGISTRY | Ahmed Mosaad Mohamed Arafa Elsakka | View |