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临床试验/NCT04956835
NCT04956835Unknown不适用

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

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2021年7月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Drexler

Principal Investigator

Universitätsklinikum Hamburg-Eppendorf

研究点 (1)

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