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临床试验/NCT01801813
NCT01801813已完成不适用

Observational Study of Risk Factors of Neuro-critical Care Complications Regarding Patients Undergoing Brain Tumour Neuro-surgery : a Prospective Validation of the Cranioscore.

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 795 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
795
试验地点
1
主要终点
Post-operative complications requiring Neuro-ICU stay ≥ 24 hours after surgery for neurosurgical reason.

研究概览

简要总结

Patients undergoing a brain tumour neurosurgery with craniotomy may present rare but lifethreatening post-operative complications. There are currently no strong recommendations to help the clinician in an attempt to properly hospitalise these patients after their intervention (Neuro-ICU, ICU,surgical ward).

Determining risk factors of post-operative complications could optimise resources. Therefore hospitalisation in Neuro-ICU would be mandatory in only a little number of patients.

详细描述

Retrospective analysis of a prospective database to create a Risk Score. Post-operative neurosurgery complications recording (Hyponatremia < 135mmol/l,Insulin administration, Nausea-Vomiting, Glasgow Coma Score, Inhalation, Post-operative intra-cranial bleeding requiring neurosurgery, Intra-cranial hypertension, Use of osmotherapy, Status epilepticus, Brain death, Death).

Collection of datas as Duration of mechanical ventilation, Length of ICU stay, Length of hospital stay.

Validation of this score on an independent prospective cohort.

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
15 Years 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing neuro-surgery for a brain tumor

排除标准

  • Neuro-surgical emergency

结局指标

主要结局

Post-operative complications requiring Neuro-ICU stay ≥ 24 hours after surgery for neurosurgical reason.

时间窗: During ICU stay, average of 24 hours

次要结局

  • Describing post-operative complications in patients undergoing neuro-surgery for brain tumor.(During ICU stay, average of 24 hours)
  • Length of hospital stay(Duration of hospital stay, expected average 5 days)
  • Duration of mechanical ventilation(Duration of mechinal ventilation, average of 12 hours)
  • Length of ICU stay(Duration of ICU stay, average of 24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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