The Effect of Different Methods of Airway Management on the Stomatognathic System: an Observational Prospective Study.
- Conditions
- Supraglottic Airway DeviceRegional AnesthesiaAirway ManagementEndotracheal Intubation
- Interventions
- Other: Airway management techniques (exposure)
- Registration Number
- NCT05783128
- Lead Sponsor
- Aretaieio Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
- Men and women
- 18-70 years old
- ASA I-III
- elective abdominal surgery or elective gynecological surgery
- general or regional anesthesia
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Endotracheal intubation - C-MAC video-laryngoscope Airway management techniques (exposure) 3) Assist control ventilation, after intubation through the mouth, with the use of a C-MAC video-laryngoscope Supraglottic Airway Device Airway management techniques (exposure) 4) Assist control ventilation, after the insertion of an LMA (laryngeal mask airway) supreme supraglottic device Endotracheal intubation - Macintosh laryngoscope Airway management techniques (exposure) 2) Assist control ventilation, after intubation through the mouth, with the use of a Macintosh laryngoscope Spontaneous breathing Airway management techniques (exposure) 1) Spontaneous breathing, with no airway management, in surgeries performed under regional anesthesia
- Primary Outcome Measures
Name Time Method 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
Name Time Method Temporomandibular joint disc displacement (with/without reduction) 24 hours Assessement of clicking of the jaw while opening/closing the mouth using DC/TMD
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)
Subjective limitation of jaw movement 24 hours Assessement of subjective report of jaw movement limitation using DC/TMD
Articular sounds incidence 24 hours Assessement of grinding noises and nonclassifiable sounds using DC/TMD
Subjective report of orofacial pain 24 hours Assessement of subjective report of orofacial pain using DC/TMD
Trial Locations
- Locations (1)
Aretaieio Hospital, National and Kapodistrian University of Athens
🇬🇷Athens, Greece