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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Change of Tempromandibular Joint Function With Supra Glottic Airway Devices
• Intervention / Treatment: Device: Supra glottic airway devices

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Supra glottic airway devices	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in tempromandibular jiont function	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	Single measurement Within 24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other complications of supraglottic airway devices	Including aspiration and airway edema	Intra operative &24hours postoperative

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 30, 2022
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: The interincisors distance& movements of the jaw
• Other Study ID Numbers: Soh-med-21-10-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No