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

NCT ID: NCT05783128

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 134 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-07-31

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).

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Spontaneous breathing

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

Airway management techniques (exposure)

Intervention Type: OTHER

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

Airway management techniques (exposure)

Intervention Type: OTHER

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

Airway management techniques (exposure)

Intervention Type: OTHER

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

Airway management techniques (exposure)

Intervention Type: OTHER

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

Interventions

Airway management techniques (exposure)

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aretaieio Hospital

OTHER

Sponsor Role: lead

Responsible Party

Christina Orfanou

Resident anesthesiologist, MD, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Assosiate Professor Athanasia Tsaroucha

Role: STUDY_DIRECTOR

Aretaieio Hospital, National and Kapodistrian University of Athens

Locations

Aretaieio Hospital, National and Kapodistrian University of Athens

Athens, , Greece

Countries

Greece

Other Identifiers

453/21-09-2022

Identifier Type: -

Identifier Source: org_study_id