The Effect of Different Methods of Airway Management on the Stomatognathic System: an Observational Prospective Study.

Study Overview
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Brief Summary
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The manipulations required during airway management and the different methods of establishing an airway (endotracheal intubation, supraglottic airway device etc) during anesthesia, as well as certain drugs used during anesthesia and sedation, may have an impact to the stomatognathic system. These effects can vary from a subtle temporomandibular joint disc displacement with reduction to the onset of temporomandibular disorders to previously healthy subjects.This observational prospective study aims at investigating the effect of different methods of airway management during anesthesia on the stomatognathic system (including temporomandibular joint, mastication muscles, occlusion etc).

Detailed Description
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After being informed about the study, all patients giving written informed consent will undergo elective abdominal surgery or elective gynecological surgery (both open or laparoscopic surgeries), under general or regional anesthesia. Participants will be assigned to groups, depending on the method of airway management during anesthesia (endotracheal intubation, supraglottic airway device, sontaneous breathing). Clinical examination of the stomatognathic system will be performed preoperatively and postoperatively (24 hours after surgery) and data concerning signs and symptoms associated with the development of temporomandibular disorders will be recorded. A follow-up questionnaire will be administered by telephone 30 days after surgery in order to record data concerning the stomatognathic system and mandibular function. Parameters related to the physiology of the stomatognathic system, parameters related to the airway management technique, patient position, parameters related to postoperative recovery, as well as postoperative analgesic consumption will be studied.

Official Title
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The Effect of Different Methods of Airway Management on the Stomatognathic System: an Observational Prospective Study.

Conditions
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Airway Management, Endotracheal Intubation, Supraglottic Airway Device, Regional Anesthesia

Intervention / Treatment
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* Other: Airway management techniques (exposure)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women 18-70 years old ASA I-III elective abdominal surgery or elective gynecological surgery general or regional anesthesia Exclusion Criteria: edentulous patients ear disease history of head and/or neck cancer head and neck surgery, surgery that is known to affect temporomandibular joints nose and/or skull base fractures history of dystonia/musculoskeletal disease that require treatment with muscle relaxant drugs cognitive impairment ASA > 3 patients which underwent over 3 attempts of airway establishment during airway management change of anesthesia plan during surgery patient refusal to participate inability to comprehend Greek or English patient participation in another research project during the previous 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Spontaneous breathing<br>1) Spontaneous breathing, with no airway management, in surgeries performed under regional anesthesia | Other: Airway management techniques (exposure)<br>* The exposure reffers to the different methods of airway management during general or regional anesthesia.<br>|
| Endotracheal intubation - Macintosh laryngoscope<br>2) Assist control ventilation, after intubation through the mouth, with the use of a Macintosh laryngoscope | Other: Airway management techniques (exposure)<br>* The exposure reffers to the different methods of airway management during general or regional anesthesia.<br>|
| Endotracheal intubation - C-MAC video-laryngoscope<br>3) Assist control ventilation, after intubation through the mouth, with the use of a C-MAC video-laryngoscope | Other: Airway management techniques (exposure)<br>* The exposure reffers to the different methods of airway management during general or regional anesthesia.<br>|
| Supraglottic Airway Device<br>4) Assist control ventilation, after the insertion of an LMA (laryngeal mask airway) supreme supraglottic device | Other: Airway management techniques (exposure)<br>* The exposure reffers to the different methods of airway management during general or regional anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain free maximum mouth opening | Assessment of maximum pain free inter-incisor distance (measured in millimeters). The examination will be conducted using the set of diagnostic tools for temporomandibular disorders (TMD), namely the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of movement of the temporomandibular joint | Assessement of forward and lateral movements of the jaw using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) | 24 hours | 
| Temporomandibular joint disc displacement (with/without reduction) | Assessement of clicking of the jaw while opening/closing the mouth using DC/TMD | 24 hours | 
| Articular sounds incidence | Assessement of grinding noises and nonclassifiable sounds using DC/TMD | 24 hours | 
| Subjective limitation of jaw movement | Assessement of subjective report of jaw movement limitation using DC/TMD | 24 hours | 
| Subjective report of orofacial pain | Assessement of subjective report of orofacial pain using DC/TMD | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intubation, Laryngeal Masks, Temporomandibular Joint Disorders, Orofacial Pain