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临床试验/NCT05204914
NCT05204914Unknown不适用

Effect Of Supraglottic Airway Devices On The Tempromandibular Joint Function Following Prolonged General Anesthesia

Sohag University0 个研究点目标入组 60 人开始时间: 2022年1月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
主要终点
Change in tempromandibular jiont function

研究概览

简要总结

Effect Of Supraglottic Airway Devices On The Tempromandibular Joint function Following Prolonged General Anesthesia

详细描述

Supraglottic airway devices (SADs) are used for securing the airway in over 50% of general anesthetics; They are used for both spontaneously & ventilated patients; They also used as conduits to aid endotracheal intubation when both positive mechanical ventilation ( PMV) & tradional endotracheal intubation( ETT) have failed

All (SADs) consist of a tube that connected to a breathing circuit or a breathing bag which is attached to a hypopharengeal device that seals air flow to the glottis

There are many types of SADs including I-Gel, intubating laryngeal mask airway (LMA), LMA CTrash and LMA proseal Although considered relatively safe devices; and have many advantages as they are less invasive than EET, less incidence of bronchospasm, don't often require muscle relaxation or neck mobility

There are several potential complications & disadvantages ; Include temporomandibular joint (TMJ) dysfunction, increases the risk of aspiration, more gas leak &pollution, less safe in prone postion & deeper anaethesia is required

This study will investigate (TMJ) dysfunction following the use of a (SAD) during general anesthesia, as There are a number of insertion maneuvers described for (SADs) [2] such as a jaw thrust may result in temporomandibular joint (TMJ) dysfunction by anteriorly displacing the mandible . In addition, other factors such as degree of muscle relaxation leading to hypotonicity of jaw muscles and passive mouth opening. In addition, for the duration of the operation the mouth is kept slightly open by a breathing tube may result in (TMJ) dislocation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

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

入选标准

  • •Inclusion The study will include 60 adult patients (>18 years old) with ASA physical status class I and class II scheduled for elective surgery under general anesthesia where SADs ara planned to be used as airway devices

排除标准

  • •Patient refusal
  • •limited mouth opening(<2 fingers)
  • •Facial &upper airway trauma
  • •Patients with dentures or who were edentulous (as accurate objective measurements would be difficult to determine)
  • •Head and neck surgery (as surgery may influence TMJ function)
  • •GITsurgery (as SAD doesn't completely protect air way against aspiration )
  • •Pt with preexisting tempromadibular joint dysfunction
  • •Duration of anaethesia less than 1 h or more than 4hs-

研究组 & 干预措施

Supra glottic airway devices

Other

干预措施: Supra glottic airway devices (Device)

结局指标

主要结局

Change in tempromandibular jiont function

时间窗: Single measurement Within 24 hours postoperative

The change in inter incisors distance,forword movement\&lat movement of the jow post operative will be measured also any post op pain or difficulty in movement of the jow will be recorded

次要结局

  • Other complications of supraglottic airway devices(Intra operative &24hours postoperative)

研究者

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

Aya mohammed el_otafey

Principal investigator

Sohag University

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