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临床试验/NCT07014345
NCT07014345撤回不适用

Double-Lumen Tube Intubation in the Lateral Position Versus the Supine Position on First-Attempt Success Rate Among Patients Undergoing Thoracic Surgery: A Prospective, Randomized, Controlled, Multi-center Trial

xiangming fang1 个研究点 分布在 1 个国家目标入组 620 人开始时间: 2022年12月1日最近更新:

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
620
试验地点
1
主要终点
Successful First-Pass Intubation

研究概览

简要总结

The aim of this clinical trial is to find out the first success rate of double lumen intubation in the lateral position in thoracic surgery, it will also find out the safety of double lumen tube intubation in the lateral position. The trial aims to answer the following key questions

Does intubation in lateral position improve the first-time success rate of double-lumen intubation compared with in the supine position? What medical problems can participants experience during double lumen tube intubation in the lateral position? The researchers will compare double lumen intubation in the lateral position vs supine position to see if the position is effective in the success rate of double lumen intubation.

Participants will

Use the supine or lateral position during intubation

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • need for DLT intubation with elective unilateral thoracoscopic surgery
  • age 18-65 years
  • American Society of Anesthesiologists (ASA) grade of I or II
  • no serious cardiopulmonary disease

排除标准

  • aged <18 years or >65 years
  • body mass index >30 kg/m2
  • cognitive dysfunction and inability to assume the required body position
  • previous cervical vertebrae and expected difficult airway (e.g., Mallampati airway grade of III, IV, or higher, maximum mouth opening <3 finger widths, nail-chin distance <6 cm)
  • admission to the intensive care unit after surgery and without follow-up

结局指标

主要结局

Successful First-Pass Intubation

时间窗: Periprocedural

The primary outcome was the success rate of the first DLT intubation attempt.

次要结局

  • No. of intubation attempts(Periprocedural)
  • Intubation time(Periprocedural)
  • Interval before surgery(Periprocedural)
  • p-Peak(Periprocedural)
  • Flexible bronchoscope usage(Periprocedural)
  • the incidence of DLT malposition(Periprocedural)
  • early intubation-related complications(Periprocedural)
  • postoperative complications(Periprocedural)
  • satisfaction scores.(Periprocedural)

研究者

发起方
xiangming fang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

xiangming fang

Chair Professor, Department of Anesthesiology Vice Dean, School of Medicine and and Pharmaceutical sciences Zhejiang University

First Affiliated Hospital of Zhejiang University

研究点 (1)

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