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临床试验/NCT04450121
NCT04450121已完成不适用

Comparison Between Fekry and Air-Q Intubating Airways as Conduit for Fibreoptic Endotracheal Intubation in Adult Patients

Cairo University2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Endoscopy insertion time

研究概览

简要总结

The fibreoptic bronchoscope remains one of the most important methods of intubating patients particularly when there is difficulty with intubation.

Facilitating fiberoptic oropharyngeal intubation procedure, specific airways have been devised to push the tongue anteriorly to clear a passage for the fibrescope into the trachea.

Of these airways the Air-Q Intubating Laryngeal Airway (Air-Q) (Cookgas, St. Louis, MO, USA) and Fekry Oral Intubating Airway (Ameco Technology, Cairo, Egypt).

详细描述

The Air-Q Intubating Laryngeal Airway (Air-Q):

The Air-Q™ Intubating Laryngeal Airway (Air-Q) (Cookgas, St. Louis, MO, USA) is a SAD that was designed primarily to act as a conduit for the passage of a cuffed tracheal tube during tracheal intubation (1), Compared with the LMA, the Air-Q has a shorter silicon airway tube that allows an easy visualization of vocal cords and intubation and removal of the device after tracheal tube insertion. The device has a removable color coded connector, allows intubation through the airway tube. The device is also wider, C-curved and has an integrated bite block which makes it easier to place reinforces the tube and diminishes the need for a separate bite block, with an elevation ramp that facilitates intubation and directs the tube toward the laryngeal inlet. It also has a built-up mask for improved seal. All of these features facilitate the passage of the tracheal tube through the device and into the trachea.

Fekry airway (Oral Intubating Airway; Egyptian Patent 28118):

Several modifications of oropharyngeal airways aiming to allow facilitation of intubation and easy removal of the airway after placement of ETT.

In Fekry airway, modification of the Williams airway facilitates the airway removal after ETT insertion without need to remove the international part of the ETT (this reduce risk of ETT dislodgement during airway removal).

研究设计

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

盲法说明

Randomization will be done using computer generated number and concealed using sequentially numbered, sealed opaque envelope.

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

  • Patients aged ≥18 years old.
  • Of both sexes.
  • With American Society of Anaesthesiologists (ASA) physical status class I-ll.
  • Scheduled for elective surgery under general anesthesia requiring ETT placement.

排除标准

  • Patient refusal.
  • Patient that has any documented or suspected difficult airway or neck or upper respiratory tract abnormalities, facial deformities that invalidate Ganzouri airway score.
  • Patient that has any active cardiac or chest problem and risk of aspiration.

结局指标

主要结局

Endoscopy insertion time

时间窗: Withen 15 seconds from induction og Generel Anesthesia

Time from introducing the tip of scope through the proximal end of the airway device or mouth until the visualization of carina (multiple attempts will be added to compute this time

次要结局

  • Success rate of intubation from 1st trial(Withen 15 seconds from induction og Generel Anesthesia)
  • Score of success of endotracheal intubation(Withen 15 seconds from induction og Generel Anesthesia till Study Completion)
  • ITHIN Intubation time(Withen 15 seconds from induction og Generel Anesthesia)
  • Grade of endoscopic view(Withen 15 seconds from induction og Generel Anesthesia)
  • Number of intubation and device insertion attempts(Withen 15 seconds from induction og Generel Anesthesia)
  • Complications(Withen 15 seconds from induction og Generel Anesthesia)

研究者

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

Ahmed Abdalla

Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University

Cairo University

研究点 (2)

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