The Implementation of the Classification of Intraoperative Adverse Events (ClassIntra) for Neurosurgical Procedures

Study Overview
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Brief Summary
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In the planned study, the ClassIntra score will be assessed after all neurosurgical procedures in the upcoming 6 months and correlated with all pre- and postoperative data. Afterwards, the conclusion will be made, if the ClassIntra score could predict the postoperative course of the patients regarding their neurological and general condition. Furthermore, analyses will be made to develop novel postoperative routines adjusted to the individual ClassIntra score of the patient.

Detailed Description
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Surgeons strive for the best possible outcome of their surgeries with the greatest possible chance for recovery of the patients. Therefore, monitoring and quality improvement is increasingly important in surgery. As there are well-defined scores and classifications to describe the postoperative course regarding morbidity, mortality and neurological status, no validated classification for intraoperative quality exists by now. However, Dell-Kuster et al. introduced a novel classification for assessing all intraoperative adverse events: ClassIntra. This classification was developed in a Delphi consensus containing international, interdisciplinary, and validated in a multicentre cohort study across all surgical disciplines. The classification defines intraoperative adverse events as any deviation from the ideal intraoperative course occurring between skin incision and skin closure and contains any event related to surgery and anaesthesia. Depending on the kind of adverse event, the ClassIntra score ranges from 0 (no event) to 5 (intraoperative death). A prospective study with a main focus on neurosurgery covering the whole spectrum of elective and emergency procedures is needed. Hereby, the outcome parameters need to be defined specific for neurosurgical procedures including a preoperative and postoperative neurological status.

Official Title
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The Implementation of the Classification of Intraoperative Adverse Events (ClassIntra) for Neurosurgical Procedures

Conditions
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Surgical Complication, Neurological Morbidity, Anesthesia Morbidity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing surgery at a neurosurgical department Exclusion Criteria: Patients under 18 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications according to Clavien-Dindo classification | Grade 0 to V (0 no complication, V death) | within two weeks after surgery | 
| Comprehensive Complication Index | Based on Clavien-Dindo classification with a scale from 0 to 100 (0 no complication, 100 death) | within two weeks after surgery | 
| Neurological status | classified to NANO scale, NIHSS, modified Rankin Scale, Glasgow Outcome Scale | within two weeks after surgery | 
| Neurological outcome (NANO scale) | according to neurological assessment in neuro-oncology (NANO) with a scale from 0 to 23 (0 no neurological deficit, 23 multiple neurological deficits) | within two weeks after surgery | 
| Neurological outcome (NIHSS) | according to National Institutes of Health Stroke Scale (0 no stroke symptoms 1-4 minor stroke 5-15 moderate stroke 16-20 moderate to severe stroke 21-42 severe stroke) | within two weeks after surgery | 
| Neurological outcome (mRS) | according to modified Rankin Scale with a scale from 0 to 6 (0 no symptoms, 6 dead) | within two weeks after surgery | 
| In-hospital mortality | Death of the patient | within two weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of ICU stay |  | within two weeks after surgery | 
| Length of hospital stay |  | within two weeks after surgery | 
| Readmission rate | Readmission to hospital after discharge | within 90 days after surgery |