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

Sponsor
Aretaieio Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05783128
Collaborator
(none)
120
1
10.1
11.9

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effect of Different Methods of Airway Management on the Stomatognathic System: an Observational Prospective Study.
Actual Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Pain free maximum mouth opening [24 hours]

    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)

Secondary Outcome Measures

  1. Range of movement of the temporomandibular joint [24 hours]

    Assessement of forward and lateral movements of the jaw using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)

  2. Temporomandibular joint disc displacement (with/without reduction) [24 hours]

    Assessement of clicking of the jaw while opening/closing the mouth using DC/TMD

  3. Articular sounds incidence [24 hours]

    Assessement of grinding noises and nonclassifiable sounds using DC/TMD

  4. Subjective limitation of jaw movement [24 hours]

    Assessement of subjective report of jaw movement limitation using DC/TMD

  5. Subjective report of orofacial pain [24 hours]

    Assessement of subjective report of orofacial pain using DC/TMD

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aretaieio Hospital, National and Kapodistrian University of Athens Athens Greece 11528

Sponsors and Collaborators

  • Aretaieio Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christina Orfanou, Resident anesthesiologist, MD, MSc, Aretaieio Hospital
ClinicalTrials.gov Identifier:
NCT05783128
Other Study ID Numbers:
  • 453/21-09-2022
First Posted:
Mar 24, 2023
Last Update Posted:
Mar 24, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Christina Orfanou, Resident anesthesiologist, MD, MSc, Aretaieio Hospital

Study Results

No Results Posted as of Mar 24, 2023