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临床试验/NCT00925613
NCT00925613已完成3 期

Exchange of a Double Lumen Tube With a Proseal Laryngeal Mask or Single Lumen Endotracheal Tube Before Emergence Following a Thoracic Surgery: a Randomized-controlled Trial.

Université de Montréal1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年4月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Frequency of cough

研究概览

简要总结

The purpose of this study is to determine whether exchange of the double lumen tube before emergence with a laryngeal mask airway (Proseal) or a tracheal tube will reduce cough at emergence.

详细描述

Intubation with a double lumen tube is often the preferred method to ensure isolation of the lung and proper exposition of the surgical site during thoracoscopies and thoracostomies. Unfortunately, because of the length and diameter of the double lumen tube, it is known to cause more irritation in the upper airways thereby inducing cough at emergence. In turn, cough has been associated with numerous multisystemic complications. Severe respiratory complications include laryngospasm or upper airway obstruction, desaturation, vocal cord injury, tracheal and bronchial ruptures. The purpose of this study is to determine whether exchange of the double lumen tube before emergence with a laryngeal mask airway (Proseal) or a tracheal tube will reduce cough at emergence.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •18-75 year old undergoing elective thoracic surgery
  • •intubation with double lumen tube required
  • •patients in category ASA 1, 2, 3

排除标准

  • •Difficult intubation anticipated
  • •Presence of gastro-esophageal reflux
  • •Patients considered with a full stomach
  • •Body mass index >30
  • •Presence of nasogastric tube when exchange should be done
  • •Patients undergoing oesophagogastrectomy
  • •Allergy to any medication used in the study

研究组 & 干预措施

Control

No Intervention

The double lumen tube is kept until extubation; there is no exchange with any tracheal tube or LMA.

Proseal

Active Comparator

The double lumen tube is exchanged with a Proseal (LMA) before emergence according to the study protocol.

干预措施: LMA Proseal (Device)

Tracheal tube

Active Comparator

The double lumen tube is exchanged with a tracheal tube before emergence according to the study protocol.

干预措施: Tracheal tube (Device)

结局指标

主要结局

Frequency of cough

时间窗: From change to supine position to 10 minutes after removal of airway device

次要结局

未报告次要终点

研究者

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

Issam Tanoubi

Université de Montréal

Université de Montréal

研究点 (1)

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