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

NCT ID: NCT05204914

Last Updated: 2022-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-30
• Study Completion Date: 2022-12-30

Brief Summary

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

Detailed Description

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.

The inter-incisor distance will be measured using a Therabite â ruler (ATOS Medical, Nottingham, UK). This has a scale from 0 to 70 mm with 1-mm markings. The accuracy of this type of ruler is1.0 mm. The Therabite ruler was chosen as it routinely used by the investigators for (TMJ) assessment in the maxillofacial clinic.

Conditions

Change of Tempromandibular Joint Function With Supra Glottic Airway Devices

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Supra glottic airway devices

Group Type: OTHER

Supra glottic airway devices

Intervention Type: DEVICE

Using the device in save air way in patients under general anesthesia and the change in the tempromandibular joint will be evaluated

Interventions

Supra glottic airway devices

Using the device in save air way in patients under general anesthesia and the change in the tempromandibular joint will be evaluated

Intervention Type: DEVICE

Eligibility Criteria

Exclusion Criteria

1. Patient refusal

2. limited mouth opening(<2 fingers)

3. Facial &upper airway trauma

4. Patients with dentures or who were edentulous (as accurate objective measurements would be difficult to determine)

5. Head and neck surgery (as surgery may influence TMJ function)

6. GITsurgery (as SAD doesn't completely protect air way against aspiration )

7. Pt with preexisting tempromadibular joint dysfunction

8. Duration of anaethesia less than 1 h or more than 4hs-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Aya mohammed el_otafey

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Soh-med-21-10-05

Identifier Type: -

Identifier Source: org_study_id