The Implementation of the Classification of Intraoperative Adverse Events (ClassIntra) for Neurosurgical Procedures
试验速览
- 阶段
- 不适用
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Complications according to Clavien-Dindo classification
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing surgery at a neurosurgical department
排除标准
- •Patients under 18 years
结局指标
主要结局
Complications according to Clavien-Dindo classification
时间窗: within two weeks after surgery
Grade 0 to V (0 no complication, V death)
In-hospital mortality
时间窗: within two weeks after surgery
Death of the patient
Neurological status
时间窗: within two weeks after surgery
classified to NANO scale, NIHSS, modified Rankin Scale, Glasgow Outcome Scale
Comprehensive Complication Index
时间窗: within two weeks after surgery
Based on Clavien-Dindo classification with a scale from 0 to 100 (0 no complication, 100 death)
Neurological outcome (mRS)
时间窗: within two weeks after surgery
according to modified Rankin Scale with a scale from 0 to 6 (0 no symptoms, 6 dead)
Neurological outcome (NANO scale)
时间窗: within two weeks after surgery
according to neurological assessment in neuro-oncology (NANO) with a scale from 0 to 23 (0 no neurological deficit, 23 multiple neurological deficits)
Neurological outcome (NIHSS)
时间窗: within two weeks after surgery
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)
次要结局
- Readmission rate(within 90 days after surgery)
- Length of ICU stay(within two weeks after surgery)
- Length of hospital stay(within two weeks after surgery)
研究者
Richard Drexler
Principal Investigator
Universitätsklinikum Hamburg-Eppendorf
