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

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).

Study Overview

• Status: Completed
• Conditions: Endotracheal Intubation; Airway Management; Supraglottic Airway Device; Regional Anesthesia
• Intervention / Treatment: Other: Airway management techniques (exposure)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 134

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11528
    • Aretaieio Hospital, National and Kapodistrian University of Athens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-70, of either sex (male, female), American Society of Anesthesiologists (ASA) physical status I-III and scheduled for elective abdominal surgery or elective gynecological surgery (both open or laparoscopic surgeries), under general or regional anesthesia, will be enrolled in the study. They will voluntarily participate in the study, have given their informed consent in writing. Participants will be assigned to groups, depending on the method of airway management during anesthesia.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aretaieio Hospital
• Investigators: Study Director: Assosiate Professor Athanasia Tsaroucha, Aretaieio Hospital, National and Kapodistrian University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: March 12, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Intubation; Orofacial Pain; Temporomandibular Joint Disorders; Laryngeal Masks
• Other Study ID Numbers: 453/21-09-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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