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临床试验/NCT02850757
NCT02850757已完成不适用

Comparative Study Between Modified William's Airway (Fekry Airway ) Versus the U Shaped Guedl's Airway as Assessed Device for Fiberoptic Intubation.

Cairo University0 个研究点目标入组 50 人开始时间: 2016年8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
50
主要终点
Time of endotracheal intubation

研究概览

简要总结

This study will compare the efficacy of modified William's airway versus U shaped Guedl's airway in assistant of fiberoptic bronchoscope during endotracheal intubation

详细描述

Several oropharyngeal airways and supraglotic devices have been invented to facilitate the art of fiber optic intubation. The oropharyngeal airways help during fiber optic intubation through raising the soft palate and the tongue away from the field of bronchoscope .(1)The modification made to the Williams airway (Fekry's airway) is that the roof of the proximal cylindrical tunnel was removed and opened from its concave part to allow one step insertion of the tube. There is no need for removal of the tube connector or the airway after tube insertion.(3)We invented a new modification in Guedel's airway (The U-shaped Guedel's airway) which is made by making an inverted Y shape cut in the roof of the airway keeping only the proximal Y wings and removing the distal part of the roof.This study will be conducted at Kasr AL-Ainy Hospital Faculty of Medicine Cairo university Egypt , after approval of the ethical committee and taking written informed consents from the patients . Patients presents to the hospital for elective surgery under general anasethia will be randomly divided into 2 groups : Group W (Gw)(n=25 ) the fiber optic intubation will be assisting by modified Williams airway and Group U (Gu)(n=25) the fiber optic intubation will be assisting by U shaped Guedels airway .

In the preparation room 20 guage cannula will be inserted in a peripheral vein . 0,02 mg\ Kg midazolam and 0,01 mg\Kg atropine will be given in the operating room Standard monitors ( ECG, noninvasive Blood pressure and pulse oximetry) will be established to the patient .After 3 minutes preoxygenation with 100% O2 induction was conducted using 1µg\Kg fentanyl,2mg\Kg propofol and 0.05 mg\Kg atracurium. After loss of consciousness the selected airway according to group randomization was inserted into the mouth (size selection and technique of insertion was done according to manufacturer structures . The patient will be ventilated by facemask and bag with 100% oxygen and 1-2% isoflourane. Complete neuromuscular block was confirmed using nerve stimulator (train of four zero).the fiber optic bronchoscope inserted through the airway (modified Williams, U Shaped Guedels airway ) according to the patient group . The time of fiber optic bronchoscope insertion will be recorded in seconds (defined as the time elapsing from the entry of fiber optic bronchoscope through the airway till touching the vocal cords by the tip of bronchoscope) . The investigator will assesse the bronchoscopic view just after the end of the airway . after recording the time of fiberopticbronchoscope insertion the endotracheal tube was slided through vocal cords into the trachea reaching the carina . the patient will be ventilated through the endotracheal tube using intermittent positive pressure ventilation (IPPV) . Endotracheal intubation will be confirmed by chest expansion ,bilateral equal air entry using stethoscope and the appearance 6 successive capnographic waves. Time of intubation will be recorded from stop mask-bag ventilation till reventilate the patient using the endotrachealtube and reading of capnogram. ( the attempt will be cancelled and bag-mask ventilation started if SPO2 reach 93%. )

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • Patient aged above 18 years old.
  • Patient that has ASA I,II .
  • Patient with Ganzouri airway score less than 4.

排除标准

  • Patient aged below 18 years old.
  • Patient that has ASA III ,IV.
  • Patients at risk of aspiration of gastric content.
  • Patient with Ganzouri airway score equal or more than
  • Patient that has any anatomical abnormality that invalidate Ganzouri airway score.

研究组 & 干预措施

U shaped Guedl's airway

Experimental

干预措施: U shaped Guedl's airway (Device)

Modified William's airway(Fekry airway )

Experimental

干预措施: Modified William's airway (Device)

结局指标

主要结局

Time of endotracheal intubation

时间窗: within 15 minutes from induction of general anesthesia

次要结局

  • Time of fiberopticc bronchscpe reach the vocal cords(within 15 minutes from induction of general anesthesia)
  • Bronchoscopic view grade(within 15 minutes from induction of general anesthesia)

研究者

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

Sherin Refaat

lecturer of Anasethiology and pain managment

Cairo University

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