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临床试验/NCT03079362
NCT03079362已完成不适用

SDR Monitoring in Children With Cerebral Palsy - a Retrospective Cohort Study

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2007年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
148
试验地点
1
主要终点
The frequency distribution pattern of the grading assessed by SDR monitoring Electromyogram (EMG) procedure

研究概览

简要总结

The study evaluates the anatomical distribution of the assessed Electromyogram (EMG) responses ensuring after sensory nerve root stimulation and obtained IOM grading during selective dorsal rhizotomy (SDR) with regard to level and, side of the body and gender as well as pain management and outcome data.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
2 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female children with spastic cerebral palsy undergoing selective dorsal rhizotomy surgery including intraoperative neuromonitoring

排除标准

  • > 21 years

结局指标

主要结局

The frequency distribution pattern of the grading assessed by SDR monitoring Electromyogram (EMG) procedure

时间窗: During the operation

次要结局

  • Functions scores(Up to 12 months)
  • Reoperations(Up to 12 months)
  • Gait(Up to 12 months)
  • Gross motor function measure(Up to 12 months)
  • Strength(Up to 12 months)
  • Spasticity(Up to 12 months)
  • Range of motion(Up to 12 months)
  • Intensive care unit length of stay(Participants will be followed for the duration of hospital stay, an expected average of 1 day)
  • Length of hospital stay(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
  • Pain(Up to 12 months)
  • Satisfaction with pain therapy(Up to 12 months)
  • Ready to discharge(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
  • Duration of ventilation(Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day)
  • Organ complications(Up to 12 months)
  • Adverse reactions of pain therapy(Up to 12 months)
  • Infections(Up to 12 months)
  • Delirium(Up to 12 months)
  • Temperature(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
  • Therapy of adverse reactions of pain therapy(Up to 12 months)
  • Routine laboratory(Up to 12 months)
  • Pain therapy(Up to 12 months)
  • Gross motor function classification system(Up to 12 months)
  • Positional control of epiperidural catheter(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
  • Gait analysis instrumented three dimensional(Up to 12 months)
  • Modified Ashworth Scale(Up to 12 months)

研究者

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

Claudia Spies

Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany

Charite University, Berlin, Germany

研究点 (1)

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