Surveillance peropératoire de la déformation vertébrale.
SDIM : Surveillance peropératoire des déformations vertébrales. Comprendre et gérer les changements de neuromonitoring peropératoires pendant la chirurgie de la déformation vertébrale : une étude interventionnelle prospective
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Saint Leonards, Australie, 2065
- Royal North Shore Hospital
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Florianópolis, Brésil, 88025
- Hospital Infantil Joana de Gusmão
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São Paulo, Brésil
- Hospital das clinicas de São Paulo e AACD
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Montreal, Canada
- Montreal General Hospital
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Montreal, Canada, 124001
- Shriners Hospital for Children
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Toronto, Canada, M5T 2S8
- Toronto Western Hospital
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Nanjing, Chine, 210008
- Nanjing Drum Tower Hospital
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Barcelona, Espagne, 08035
- Hospital Vall d'Helbron
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Hong Kong, Hong Kong
- Queen Mary Hospital
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Guntur, Inde, 522001
- Mallika Spine Centre
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Kolkata, Inde, 700027
- Kothari Medical Centre
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Tel Aviv, Israël
- Tel Aviv Medical Center - Dana Children's Hospital
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Hamamatsu, Japon
- Hamamatsu University School of Medicine
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Lahore, Pakistan
- Ghurki Trust Teaching Hospital
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Nijmegen, Pays-Bas
- University Medical Center St. Radboud
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London, Royaume-Uni
- Guys Hospital
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Manchester, Royaume-Uni
- Salford Royal Hospital
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Nottingham, Royaume-Uni, NG7 2UH
- Nottingham Queens Medical Centre
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Istanbul, Turquie (Türkiye), 34457
- Acibadem Maslak Hospital
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California
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San Francisco, California, États-Unis, 94143
- UC San Franciisco
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55454
- University of Minnesota
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New York
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New York, New York, États-Unis, 10032
- Columbia University Medical Center
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North Carolina
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Durham, North Carolina, États-Unis, 27710
- Duke University Medical Center
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Virginia
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Charlottesville, Virginia, États-Unis, 22904
- University of Virginia
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
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Age >10 years to <80 years
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Neurologically intact spinal cord (with or without radiculopathy)
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Undergoing primary or revision procedure in the spine
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Anterior and/or posterior surgical approach for any of the following:
- Correction of spinal deformity with a major Cobb angle of ≥ 80° in the coronal or sagittal plane
- Correction of high grade spondylolisthesis (Grades 3- 5)
- Posterior column or 3-column osteotomy
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Requiring multimodal neuromonitoring with EMG, SSEP, and MEP as per standard of care
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Informed consent obtained for patients i.e.:
- Ability to understand the content of the patient information
- Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
- Signed and dated EC/IRB approved written informed consent OR
- Written consent obtained according to defined and IRB/EC approved procedures for patients who are not able to provide independent written informed consent
Exclusion Criteria: • Neurodegenerative disease
- Upper motor neuron lesion
- Growing rods or growth guidance procedures
- Tether or staple procedures
- Stand-alone cervical deformity correction procedures
- Any not medically managed severe systemic disease
- Recent history of substance abuse (ie recreational drugs, alcohol) that would preclude reliable assessment
- Pregnancy or women planning to conceive within the study period
- Prisoner
- Participation in any other medical device or medicinal product study that could influence the results of the present study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: Intraoperative Maneuvers
To document intraoperative maneuvers performed in response to alerts |
Monitoring procedure during surgery |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Patients Who Had at Least One Intraoperative Neuromonitoring Alert
Délai: Intraoperative, on average 6.3 hours
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Number of intraoperative neuromonitoring alert, defined as a major change in neuromonitoring signals:
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Intraoperative, on average 6.3 hours
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Patients With IONM Alerts by Modality Combination
Délai: Intraoperative, on average 6.3 hours
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Count of IONM alerts and modalities affected |
Intraoperative, on average 6.3 hours
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Preceding Events
Délai: Intraoperative, on average 6.3 hours
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Data from the safety set was used to analyze the events preceding the alerts. |
Intraoperative, on average 6.3 hours
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De Novo Neurological Deficit
Délai: At discharge or 30 days postoperative (which ever occurs first)
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A de novo neurological deficit is defined as:
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At discharge or 30 days postoperative (which ever occurs first)
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Number of Patient With Different Recovery Status of Alerts
Délai: Intraoperative
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Status of alert recovery |
Intraoperative
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- SDIM
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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