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

Airway Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05783128
• Other study ID #: 453/21-09-2022
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: March 2023
• Source: Aretaieio Hospital
• Contact: Christina Orfanou, DDS, MD
• Phone: 00306942215953
• Email: chrisorf[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Airway management techniques (exposure)
The exposure reffers to the different methods of airway management during general or regional anesthesia.

Locations

Country	Name	City	State
Greece	Aretaieio Hospital, National and Kapodistrian University of Athens	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Aretaieio Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Temporomandibular joint disc displacement (with/without reduction)	Assessement of clicking of the jaw while opening/closing the mouth using DC/TMD	24 hours
Secondary	Articular sounds incidence	Assessement of grinding noises and nonclassifiable sounds using DC/TMD	24 hours
Secondary	Subjective limitation of jaw movement	Assessement of subjective report of jaw movement limitation using DC/TMD	24 hours
Secondary	Subjective report of orofacial pain	Assessement of subjective report of orofacial pain using DC/TMD	24 hours