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临床试验/NCT00948350
NCT00948350已完成不适用

Anesthesia for Awake Fiberoptic Intubation in Patients With Cervical Instability - Comparison of Translaryngeal Injection and "Spray as You go"-Technique

Klinikum St. Georg gGmbH2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2009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
120
试验地点
2
主要终点
patients satisfaction with anesthesia

研究概览

简要总结

This is a prospective, comparative, randomized, monocentric, clinical open study, to compare two anesthesia techniques (translaryngeal injection vs. spray as you go) in patients with cervical instability with regard to technical modalities and quality of fiberoptic awake intubation.

详细描述

In patients with cervical instability anesthesia induction and conventional intubation are associated with the risk of neurological harm. Therefore the method of choice for anesthesia induction is the fiberoptic awake intubation. This method allows to place the ventilation tube without movement of the cervical spinal cord. This procedure is very uncomfortable for the patient and needs the application of topic and/or systemic anesthetics.

With this clinical study we will compare two established techniques for local laryngeal anesthesia with regard to the quality of technical modalities and postoperative outcome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with cervical instability undergoing elective decompression of cervical spine

排除标准

  • patient refused participation
  • contraindications for awake intubation techniques (e.g. nasal bleeding, anatomical disorders)
  • patient under alcohol or drugs
  • emergency surgery

结局指标

主要结局

patients satisfaction with anesthesia

时间窗: up to two weeks after hospital admission

participants will be followed for the duration of hospital stay, an expected average of 2 weeks

次要结局

  • pain after anesthesia(Change from Baseline in pain after anesthesia at end of hospital stay)

研究者

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

Armin Sablotzki, MD

Prof. Dr. med.

Klinikum St. Georg gGmbH

研究点 (2)

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