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

NCT05783128 | Completed DMC

• 1 other identifier: 453/21-09-2022
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Airway Management; Endotracheal Intubation; Supraglottic Airway Device; Regional Anesthesia

Keywords

Intubation; Laryngeal Masks; Temporomandibular Joint Disorders; Orofacial Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Range of movement of the temporomandibular joint

  24 hours

• Temporomandibular joint disc displacement (with/without reduction)

  24 hours

• Articular sounds incidence

  24 hours

• Subjective limitation of jaw movement

  24 hours

• Subjective report of orofacial pain

  24 hours

Study Arms (4)

Spontaneous breathing

1\) Spontaneous breathing, with no airway management, in surgeries performed under regional anesthesia

Other: Airway management techniques (exposure)

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)

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)

Supraglottic Airway Device

4\) Assist control ventilation, after the insertion of an LMA (laryngeal mask airway) supreme supraglottic device

Other: Airway management techniques (exposure)

Interventions

Airway management techniques (exposure) OTHER

The exposure reffers to the different methods of airway management during general or regional anesthesia.

Endotracheal intubation - C-MAC video-laryngoscope; Endotracheal intubation - Macintosh laryngoscope; Spontaneous breathing; Supraglottic Airway Device

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Men and women
• years old
• ASA I-III
• elective abdominal surgery or elective gynecological surgery
• general or regional anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Aretaieio Hospital: lead

Study Sites (1)

Aretaieio Hospital, National and Kapodistrian University of Athens

Athens, 11528, Greece

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Facial Pain

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Assosiate Professor Athanasia Tsaroucha

  Aretaieio Hospital, National and Kapodistrian University of Athens

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident anesthesiologist, MD, MSc

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: March 24, 2023
• Study Start: March 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: July 31, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Locations

GR (1)