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临床试验/NCT04103047
NCT04103047已完成不适用

Temporomandibular Joint (TMJ) Dysfunction Following the Use of Supraglottic Airway Devices

University Hospitals Coventry and Warwickshire NHS Trust2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2019年9月23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
130
试验地点
2
主要终点
Difference between preoperative and postoperative lateral jaw movement in mm

研究概览

简要总结

The aim of this study is to assess how the use of a breathing tube (Supraglottic Airway Device) can affect the function of the jaw joint (Temporomandibular joint) movement. This type of breathing tube is used for nearly 60% of general anaesthetics. To facilitate insertion of this breathing tube, assisted mouth opening and forward movement of the jaw are required.

These movements occur at the jaw joint (temporomandibular joint). In addition, for the duration of the operation the mouth is kept slightly open by a breathing tube. There are a few case reports in the literature suggesting minor effect on the jaw joint. Therefore, we wish to study this further by evaluating the function of the jaw joint, 4 to 24 hours after the operation.

详细描述

  1. INTRODUCTION 1.1 Background Supraglottic airway devices (SADs) are part of the mainstay of anaesthetic practice, being the primary airway management device in 56% of general anaesthetics. SADs are used by both novice and experienced anaesthetists, in addition to anaesthetic practitioners, non-anaesthetic clinicians and other health care professionals. They are routinely used to deliver anaesthetic gases and oxygen to the patient during general anaesthesia. In an airway emergency, for example in the case of failed intubation, a second-generation SAD has been recommended as a rescue device to maintain oxygenation. This can also then be used as a conduit to intubate the trachea.

Although insertion of SADs considered to be relatively easy, it requires certain manoeuvres. These include extension of the head and neck flexion, use of a jaw thrust with adequate mouth opening, and then introduction of the device with a firm and gentle motion down and backwards along the hard palate. These methods are thought to improve the time to successful insertion of the SAD. Whilst movements such as these can be viewed as simple and 'benign', investigators are concerned that these can cause dysfunction of temporomandibular joint dysfunction in the postoperative period.

Most published research has been focused on insertion success and time taken to insert the device. There has been limited research and literature about complications following SAD insertion, such as gastric aspiration, trauma to or loss of the airway, and about best insertion techniques, as mentioned above, including use of thermally softened SADs.

However, there are few reports of TMJ dysfunction and dislocation following SAD insertion under general anaesthesia. This may be due in part to general anaesthesia causing reduced muscle tone and greater joint mobility, but investigators assume a degree of dysfunction is due to passive manipulation of the TMJ with forward movement of the jaw and widened mouth opening for a prolonged period of time.

Some TMJ dysfunction may also be attributed to use of the SAD itself being in situ for a prolonged period, where the cuff of the device occupies the oropharynx causing forward displacement of the jaw. The recommended duration of SAD insertion ranges from one to four hours.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • All patients aged above 18, presenting for elective surgical procedure under general anaesthesia, where a supraglottic airway device can be used as primary airway device. This involves a group of patients presenting for day case surgical procedures.

排除标准

  • • Patients under the age of 18
  • Patients who do not consent to being part of the study
  • Patients in whom SAD is unlikely to be the primary airway device
  • If a translator is not available at the time, participants who cannot reasonably read and communicate in English

结局指标

主要结局

Difference between preoperative and postoperative lateral jaw movement in mm

时间窗: within 24 hours

The difference between preoperative and postoperative lateral jaw movement in mm. Lateral movement of the lower jaw (the lateral sliding of midpoint of lower jaw in reference to midline is measured in mm. This reference is repeated in the postoperative period between 4 to 24 hours after the surgery. The measurements will be done using TheraBite ruler (ATOS medical, Nottingham, UK). The data are compared using paired t test or Mann-Whitney U test.

Difference between preoperative and postoperative interincisor distance in mm

时间窗: within 24 hours

The primary outcome measure is the difference between preoperative and postoperative interincisor distance in mm. When mouth is fully opened, the distance between the incisor teeth is measured in mm. This measurement is repeated in the postoperative period between 4 to 24 hours after the surgery. The measurements will be done using TheraBite ruler (ATOS medical, Nottingham, UK). The data are compared using paired t test or Mann-Whitney U test.

次要结局

  • Patient reported pain in the jaw joint (temporomandibular joint)(Within 24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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