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

Aretaieio Hospital

Status: Completed

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

Treatments: Other: Airway management techniques (exposure)

Study type: Observational

Funder types: Other

Identifiers

NCT05783128

453/21-09-2022

Details and patient eligibility

About

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).

Full 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.

Enrollment: 134 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

134 participants in 4 patient groups

Spontaneous breathing

Description:

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

Treatment:

Other: Airway management techniques (exposure)

Endotracheal intubation - Macintosh laryngoscope

Description:

2) Assist control ventilation, after intubation through the mouth, with the use of a Macintosh laryngoscope

Treatment:

Other: Airway management techniques (exposure)

Endotracheal intubation - C-MAC video-laryngoscope

Description:

3) Assist control ventilation, after intubation through the mouth, with the use of a C-MAC video-laryngoscope

Treatment:

Other: Airway management techniques (exposure)

Supraglottic Airway Device

Description:

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

Treatment:

Other: Airway management techniques (exposure)