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临床试验/NCT03929445
NCT03929445已完成不适用

A Comparative Study Between Air-Q Intubating Laryngeal Mask And Fastrach Intubating Laryngeal Mask By Using Bougie Assisted Endotracheal Intubation

Suez Canal University2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2017年1月最近更新:
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
62
试验地点
2
主要终点
success rate of endotracheal intubation on the first, second and third attempts in both devices Air-Q and fastrach

研究概览

简要总结

This study aims to compare using bougie as an assistant for endotracheal intubation through Air-Q and Fastrach intubating laryngeal mask devices when blind intubation fails as attempt to increase its success rate.

详细描述

The investigators hypothesis that using bougie with its smaller caliber or lesser size can facilitate intubation and improve success rate when blind intubation through both devices fails.

Study objectives

  • To make a comparison between Air-Q intubating laryngeal mask and Fastrach intubating laryngeal mask by using bougie assisted endotracheal intubation through both devices in patients undergoing elective surgeries in Suez Canal Hospitals.
  • To assess the first trial success rate, the total success rate, time to tracheal intubation, the number of attempts, hemodynamics and adverse events.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient aged >18 years old.
  • Gender both male and female.
  • Patients are ASA I (American Society of Anesthesiologists' physical status Grade I) normal healthy patients or ASA II patients with mild systemic disease and no functional limitations

排除标准

  • Any disorder of the cardiovascular, pulmonary, hepatic, renal, or gastrointestinal systems known from history or general examination.
  • Patients with unstable cervical spine
  • Any medical disease that may affect airway as Rheumatoid arthritis.
  • Patient refusal to participate in the study.

研究组 & 干预措施

I-LMA group

Active Comparator

the group which selected randomly to try I-LMA device

干预措施: Endotracheal tube introducers (Device)

AIR-Q group

Active Comparator

the group which selected randomly to try AIR-Q device

干预措施: Endotracheal tube introducers (Device)

结局指标

主要结局

success rate of endotracheal intubation on the first, second and third attempts in both devices Air-Q and fastrach

时间窗: 180 seconds after anethesia induction

If the blind intubation is failed through Air Q or Fastrack Intubating laryngeal mask the investigator will use gum elastic bougie to facilitate introducing an endotracheal tube estimation of success rate of endotracheal intubation on the first, second and third attempts

The time needed for devices insertion (Air Q and Fastrach Intubating Laryngeal mask)

时间窗: !80 seconds after anesthesia induction

1. Air Q and Fastrach Intubating laryngeal mask insertion time in seconds will be measured (device time). 2. Endotracheal tube (ETT) insertion time will be measured ( ETT time). 3. Total insertion time will be estimated (Device Time + ETT Time )

次要结局

  • Incidence of adverse events(Intraoperative and in the first 48 postoperative hours)

研究者

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

Ghada A.Kamhawy

Clinical professor

Suez Canal University

研究点 (2)

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