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临床试验/NCT05744388
NCT05744388尚未招募不适用

Efficacy of Lubricating the Under Surface of Glidescope Blade Stylet Shape Modification to Facilitate Endotracheal Intubation for Suspected Difficult Intubation; A Prospective Randomized Controlled Trial

Ain Shams University0 个研究点目标入组 60 人开始时间: 2023年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Intubation time in seconds

研究概览

简要总结

The undersurface of the disposable blade of the Glidescope will be lubricated by a jelly substance to facilitate its entrance to the mouth without trauma to the soft tissues. In addition the stylet ( Gliderite) shape will be modified to be an obtuse angle. This technique modification will be applied for obese patients with suspected difficult intubation criteria who are scheduled for bariatric surgeries.

详细描述

Endotracheal tube diameter size 7.5 mm and disposable rigid blade size 3 for the female patients and ETT diameter size 8.00 mm and disposable rigid blade size 4 for the male patients will be prepared. The under surface of the blade will be lubricated by soluble jelly, taking care not to touch the camera source of light.

The stylet will be more obtuse angle than the standard shape. The stylet will be lubricated also before being fitted inside the endotracheal tube. The blade will be introduced inside the mouth midline, the tube will be held from the upper third and introduced in the midline also sliding over the blade and introduced inside the glottis. Once the tip of the tube introduced inside the glottis, the stylet will be removed and the tube will be advanced more inside the trachea. The equality of air entry will be assessed by the stethoscope and the tube will by fixed by adhesive tape after inflating the cuff.

If during intubation the used technique failed to introduce the tube, we will do ETT rotation inside the mouth or upward stylet angulation outside the mouth then will be reintroduced again. If Glidescope failed to intubate, we will use intubating LMA to intubate the patients. If all trials failed to intubate the patients. Sugamadex 16 mg/Kg will be injected to awaken the patients. After intubation the large gastric tube will be introduced in the esophagus under vision by the Glidescope help also.

Group 2:

The second group will be a control group, they will be handled by the standard shape of the stylet and the blade without lubrication.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •ASA physical status II or III
  • •BMI more than 35
  • •Patients presenting with at least one predictor for a difficult airway.
  • •The airway difficulty is at least score 3 as an indicator of difficulty.

排除标准

  • •Patients who may need rapid sequence induction

研究组 & 干预措施

Stylet shape modification group

Active Comparator

Endotracheal tube diameter size 7.5 mm and disposable rigid blade size 3 for the female patients and ETT diameter size 8.00 mm and disposable rigid blade size 4 for the male patients will be prepared. The under surface of the blade will be lubricated by soluble jelly, taking care not to touch the camera source of light.

The stylet will be more obtuse angle than the standard shape. The stylet will be lubricated also before being fitted inside the endotracheal tube. The blade will be introduced inside the mouth midline, the tube will be held from the upper third and introduced in the midline also sliding over the blade and introduced inside the glottis. Once the tip of the tube introduced inside the glottis, the stylet will be removed and the tube will be advanced more inside the trachea. The equality of air entry will be assessed by the stethoscope and the tube will by fixed by adhesive tape after inflating the cuff.

干预措施: Gliderite® shape modification (Device)

Standard shape of the stylet group

No Intervention

The second group will be a control group, they will be handled by the standard shape of the stylet and the blade without lubrication.

结局指标

主要结局

Intubation time in seconds

时间窗: intraoperative time

the intubation time will be calculated in seconds from the video screen of the Glidescope watch

次要结局

  • Number of trials of endotracheal intubation(intraoperative time)
  • mucosal damage during the intubation(intraoperative time)

研究者

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

Sabah Nageeb

Lecturer of anesthesia

Ain Shams University

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