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临床试验/NCT03116373
NCT03116373已完成不适用

Impact of Tracheal Tube Fixing Site on Its Mobility During Head Mobilization

University Hospital, Brest2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2017年5月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Maximal amplitude of the tracheal tube shifting

研究概览

简要总结

This study evaluate the secondary shifting of the tracheal tube when the head is moved under general anaesthesia. Two sites of fixation (the maxilla and the mandible) are tested in a prospective, double blind, randomized and crossover designed study.

The study test the hypothesis that taping the tracheal tube on the mandible better prevents a secondary tube move.

详细描述

Tracheal intubation is the only technique to ensure airway protection, meaning preventing aspiration, and providing mechanical ventilation during general anesthesia (GA). This is an extremely frequent procedure. After intubation, the head of the patient is often moved as the patient is positioned for the surgical procedure (ENT, thoracic and abdominal surgeries, lateral or prone positioning...). This may even happen several times during the same procedure. It is well demonstrated that these head movements are responsible for secondary shifting of the tube (1-9). This can cause accidental extubation or selective bronchial intubation.

The anesthesiologist secures the tube with tape to prevent secondary displacement of the tracheal tube. The two most common sites to tape the tube on patient's face are the maxilla, because it is a fixed spot on the face, and the mandible, because its mobility coming from the temporomandibular joint may allow a better interlock with the larynx.

There is no study and no recommendation about the best site of tape. Both techniques are commonly used, depending on the anesthesiologist's preference.

Investigators designed a, controlled study in Brest university hospital to compare two groups by cross-over intervention (one group "maxilla fixing then mandible fixing" and one group "mandible fixing then maxilla fixing").

The population is composed of adult patients undergoing bronchoscopy or endobronchial ultrasound under GA and after tracheal intubation. The bronchoscope allows a permanent control of the tracheal tube's position, and the possibility of shifting it without compromising patient security, which is not possible in other daily surgical procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

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

  • Bronchoscopy or endobronchial ultrasound
  • General anaesthesia
  • Tracheal intubation

排除标准

  • Patient incapable of consenting or with a legal guardian or declining participation
  • Forbidden or impaired cervical mobility (less than 80°)
  • Mouth opening less than 35 mm
  • Moustache or Beard

研究组 & 干预措施

maxilla fixing then mandible fixing

Active Comparator

The tracheal tube is first fixed on the maxilla. After the measures of the outcomes, its site of fixation is changed for the mandible for the outcome measurement in the second site of fixation.

干预措施: mandible fixation (Other)

maxilla fixing then mandible fixing

Active Comparator

The tracheal tube is first fixed on the maxilla. After the measures of the outcomes, its site of fixation is changed for the mandible for the outcome measurement in the second site of fixation.

干预措施: Maxilla fixation (Other)

mandible fixing then maxilla fixing

Active Comparator

The tracheal tube is first fixed on the mandible. After the measures of the outcomes, its site of fixation is changed for the maxilla for the outcome measurement in the second site of fixation.

干预措施: mandible fixation (Other)

mandible fixing then maxilla fixing

Active Comparator

The tracheal tube is first fixed on the mandible. After the measures of the outcomes, its site of fixation is changed for the maxilla for the outcome measurement in the second site of fixation.

干预措施: Maxilla fixation (Other)

结局指标

主要结局

Maximal amplitude of the tracheal tube shifting

时间窗: 2 minutes

The main outcome is the maximal amplitude of the tracheal tube shifting when the head is bended on the chest and extended in the back, controlled by bronchoscopy with each fixing technique.

次要结局

  • Movement of the tracheal tube from the neutral position(2 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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