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临床试验/NCT04253886
NCT04253886已完成不适用

Comparison of the Fekry Oral Intubating Airway and Ovassapian Fibreoptic Intubating Airway for Fibreoptic Orotracheal Intubation

Cairo University2 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2019年1月5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
350
试验地点
2
主要终点
Time of intubation

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 Ovassapian Fibreoptic Intubating Airway (Kendall, Argyle, New York, New York, USA) and Fekry Oral Intubating Airway (Ameco Tech, Cairo, Egypt).

详细描述

Ovassapian Fibreoptic Intubating Airway :

The Ovassapian Fibreoptic Intubating Airway has a flat lingual surface that widens distally. This provides better retraction of the tongue to prevent it and the soft tissues of the anterior pharyngeal wall from herniating around the side of the airway. The airway has a pair of vertical sidewalls and two pairs of curved guide walls at its proximal section. These walls are separated by a gap which allows removal of the airway after intubation has been completed.

Fekry airway:

● It has two parts are: Airway body& Special connector

  1. Airway body consists of:

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 to 60 years
  • Who presented for elective surgery requiring tracheal intubation

排除标准

  • All patients with a past history of difficult tracheal intubation
  • Patients with signs of possible difficult tracheal intubation (including modified Mallampati score 3 or 4
  • Limited mouth opening, thyromental distance < 4 cm, limited neck movement or upper airway disease

结局指标

主要结局

Time of intubation

时间窗: Up to 24 hours

Success rate of Time of intubation

次要结局

  • Advancing the endotracheal tube over the bronchoscope(Up to 24 hours)
  • Removal of the bronchoscope(Up to 24 hours)
  • Percentage of success of endotracheal tube insertion(Up to 24 hours)
  • Complications(Up to 24 hours)

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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