Airway ManagementNCT05783128
The Effect of Different Methods of Airway Management on the Stomatognathic System: an Observational Prospective Study.
An observational study of Airway Management and Endotracheal Intubation, run by Aretaieio Hospital at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Management, Endotracheal Intubation, Supraglottic Airway Device
- What is being tested?
- Airway management techniques (exposure)
- How many people
- 134 participants
- Where
- 1 siteGreece
- Study dates
- 1 Mar 2023to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 18-70, of either sex (male, female), American Society of Anesthesiologists (ASA) physical status I-III and scheduled for elective abdominal surgery or elective gynecological surgery (both open or laparoscopic surgeries), under general or regional anesthesia, will be enrolled in the study. They will voluntarily participate in the study, have given their informed consent in writing. Participants will be assigned to groups, depending on the method of airway management during anesthesia.
Who may be able to join
- Men and women
- 18-70 years old
- ASA I-III
- elective abdominal surgery or elective gynecological surgery
- general or regional anesthesia
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
Greece1 site
Aretaieio Hospital, National and Kapodistrian University of Athens
Athens, 11528
About this study
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).
Read the 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
- Being tested
- Airway management techniques (exposure)
- Keywords
- Intubation, Laryngeal Masks, Temporomandibular Joint Disorders, Orofacial Pain
- Medical subject headings
- Temporomandibular Joint Disorders, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway management techniques (exposure)Other
The exposure reffers to the different methods of airway management during general or regional anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous breathing | 1) Spontaneous breathing, with no airway management, in surgeries performed under regional anesthesia Receives: Other: Airway management techniques (exposure) | |
| Endotracheal intubation - Macintosh laryngoscope | 2) Assist control ventilation, after intubation through the mouth, with the use of a Macintosh laryngoscope Receives: Other: Airway management techniques (exposure) | |
| Endotracheal intubation - C-MAC video-laryngoscope | 3) Assist control ventilation, after intubation through the mouth, with the use of a C-MAC video-laryngoscope Receives: Other: Airway management techniques (exposure) | |
| Supraglottic Airway Device | 4) Assist control ventilation, after the insertion of an LMA (laryngeal mask airway) supreme supraglottic device Receives: Other: Airway management techniques (exposure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 hours
Secondary outcomes (5)
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)
Measured: 24 hours
Temporomandibular joint disc displacement (with/without reduction)
Assessement of clicking of the jaw while opening/closing the mouth using DC/TMD
Measured: 24 hours
Articular sounds incidence
Assessement of grinding noises and nonclassifiable sounds using DC/TMD
Measured: 24 hours
Subjective limitation of jaw movement
Assessement of subjective report of jaw movement limitation using DC/TMD
Measured: 24 hours
Subjective report of orofacial pain
Assessement of subjective report of orofacial pain using DC/TMD
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Mar 2023
- Primary completion1 Dec 2023
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aretaieio Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Orfanou, Aretaieio Hospital
- Investigators
- Assosiate Professor Athanasia Tsaroucha, Study director, Aretaieio Hospital, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783128
- Sponsor's protocol ID
- 453/21-09-2022
- Status last verified
- Oct 2024
- First submitted
- 12 Mar 2023
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Methods of Airway Management on the Stomatognathic System: an Observational Prospective Study.
- ClinicalTrials.gov ID
- NCT05783128
- Acronym / sponsor ID
- 453/21-09-2022
- Conditions
- Airway Management, Endotracheal Intubation, Supraglottic Airway Device, Regional Anesthesia
- Keywords
- Intubation, Laryngeal Masks, Temporomandibular Joint Disorders, Orofacial Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Aretaieio HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Spontaneous breathing | – | Other: Airway management techniques (exposure)1) Spontaneous breathing, with no airway management, in surgeries performed under regional anesthesia |
| Endotracheal intubation - Macintosh laryngoscope | – | Other: Airway management techniques (exposure)2) Assist control ventilation, after intubation through the mouth, with the use of a Macintosh laryngoscope |
| Endotracheal intubation - C-MAC video-laryngoscope | – | Other: 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 | – | Other: Airway management techniques (exposure)4) Assist control ventilation, after the insertion of an LMA (laryngeal mask airway) supreme supraglottic device |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-70, of either sex (male, female), American Society of Anesthesiologists (ASA) physical status I-III and scheduled for elective abdominal surgery or elective gynecological surgery (both open or laparoscopic surgeries), under general or regional anesthesia, will be enrolled in the study. They will voluntarily participate in the study, have given their informed consent in writing. Participants will be assigned to groups, depending on the method of airway management during anesthesia.
Key inclusion criteria (5 listed)
- Men and women
- 18-70 years old
- ASA I-III
- elective abdominal surgery or elective gynecological surgery
- general or regional anesthesia
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Airway management techniques (exposure)The exposure reffers to the different methods of airway management during general or regional anesthesia. | Other | Endotracheal intubation - C-MAC video-laryngoscope, Endotracheal intubation - Macintosh laryngoscope, Spontaneous breathing, Supraglottic Airway Device |
Primary outcome
Pain free maximum mouth opening
Time frame: 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)
5 secondary outcomes
Range of movement of the temporomandibular joint
Time frame: 24 hours
Temporomandibular joint disc displacement (with/without reduction)
Time frame: 24 hours
Articular sounds incidence
Time frame: 24 hours
Subjective limitation of jaw movement
Time frame: 24 hours
Subjective report of orofacial pain
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assosiate Professor Athanasia Tsaroucha study director
Aretaieio Hospital, National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Management and Endotracheal Intubation, run by Aretaieio Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain free maximum mouth opening (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.