Change of Tempromandibular Joint Function With Supra Glottic Airway DevicesNCT05204914
Effect Of Supraglottic Airway Devices On The Tempromandibular Joint Function Following Prolonged General Anesthesia
A study testing Supra glottic airway devices in people with Change of Tempromandibular Joint Function With Supra Glottic Airway Devices, run by Sohag University.
Trial summary
Effect Of Supraglottic Airway Devices On The Tempromandibular Joint function Following Prolonged General Anesthesia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Change of Tempromandibular Joint Function With Supra Glottic Airway Devices
- What is being tested?
- Supra glottic airway devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2022to 30 Dec 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patient refusal
- limited mouth opening(<2 fingers)
- Facial \&upper airway trauma
- Patients with dentures or who were edentulous (as accurate objective measurements would be difficult to determine)
- Head and neck surgery (as surgery may influence TMJ function)
- GITsurgery (as SAD doesn't completely protect air way against aspiration )
- Pt with preexisting tempromadibular joint dysfunction
- Duration of anaethesia less than 1 h or more than 4hs-
About this study
Effect Of Supraglottic Airway Devices On The Tempromandibular Joint function Following Prolonged General Anesthesia
Read the detailed description
Supraglottic airway devices (SADs) are used for securing the airway in over 50% of general anesthetics; They are used for both spontaneously \& ventilated patients; They also used as conduits to aid endotracheal intubation when both positive mechanical ventilation ( PMV) \& tradional endotracheal intubation( ETT) have failed
All (SADs) consist of a tube that connected to a breathing circuit or a breathing bag which is attached to a hypopharengeal device that seals air flow to the glottis
There are many types of SADs including I-Gel, intubating laryngeal mask airway (LMA), LMA CTrash and LMA proseal Although considered relatively safe devices; and have many advantages as they are less invasive than EET, less incidence of bronchospasm, don't often require muscle relaxation or neck mobility
There are several potential complications \& disadvantages ; Include temporomandibular joint (TMJ) dysfunction, increases the risk of aspiration, more gas leak \&pollution, less safe in prone postion \& deeper anaethesia is required
This study will investigate (TMJ) dysfunction following the use of a (SAD) during general anesthesia, as There are a number of insertion maneuvers described for (SADs) [2] such as a jaw thrust may result in temporomandibular joint (TMJ) dysfunction by anteriorly displacing the mandible . In addition, other factors such as degree of muscle relaxation leading to hypotonicity of jaw muscles and passive mouth opening. In addition, for the duration of the operation the mouth is kept slightly open by a breathing tube may result in (TMJ) dislocation.
The inter-incisor distance will be measured using a Therabite â ruler (ATOS Medical, Nottingham, UK). This has a scale from 0 to 70 mm with 1-mm markings. The accuracy of this type of ruler is1.0 mm. The Therabite ruler was chosen as it routinely used by the investigators for (TMJ) assessment in the maxillofacial clinic.
- Being tested
- Supra glottic airway devices
- Keywords
- The interincisors distance& movements of the jaw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supra glottic airway devicesDevice
Using the device in save air way in patients under general anesthesia and the change in the tempromandibular joint will be evaluated
| Study group | Role | What they receive |
|---|---|---|
| Supra glottic airway devices | Other | Not described Receives: Device: Supra glottic airway devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tempromandibular jiont function
The change in inter incisors distance,forword movement\&lat movement of the jow post operative will be measured also any post op pain or difficulty in movement of the jow will be recorded
Measured: Single measurement Within 24 hours postoperative
Secondary outcomes (1)
Other complications of supraglottic airway devices
Including aspiration and airway edema
Measured: Intra operative &24hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start30 Jan 2022 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Change of Tempromandibular Joint Function With Supra Glottic Airway DevicesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya mohammed el_otafey, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204914
- Sponsor's protocol ID
- Soh-med-21-10-05
- Status last verified
- Dec 2021
- First submitted
- 9 Dec 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Supraglottic Airway Devices On The Tempromandibular Joint Function Following Prolonged General Anesthesia
- ClinicalTrials.gov ID
- NCT05204914
- Acronym / sponsor ID
- Soh-med-21-10-05
- Keywords
- The interincisors distance& movements of the jaw
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 30 Jan 2022 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 24 Jan 2022 (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.
Effect Of Supraglottic Airway Devices On The Tempromandibular Joint function Following Prolonged General Anesthesia
Detailed description
Supraglottic airway devices (SADs) are used for securing the airway in over 50% of general anesthetics; They are used for both spontaneously \& ventilated patients; They also used as conduits to aid endotracheal intubation when both positive mechanical ventilation ( PMV) \& tradional endotracheal intubation( ETT) have failed
All (SADs) consist of a tube that connected to a breathing circuit or a breathing bag which is attached to a hypopharengeal device that seals air flow to the glottis
There are many types of SADs including I-Gel, intubating laryngeal mask airway (LMA), LMA CTrash and LMA proseal Although considered relatively safe devices; and have many advantages as they are less invasive than EET, less incidence of bronchospasm, don't often require muscle relaxation or neck mobility
There are several potential complications \& disadvantages ; Include temporomandibular joint (TMJ) dysfunction, increases the risk of aspiration, more gas leak \&pollution, less safe in prone postion \& deeper anaethesia is required
This study will investigate (TMJ) dysfunction following the use of a (SAD) during general anesthesia, as There are a number of insertion maneuvers described for (SADs) [2] such as a jaw thrust may result in temporomandibular joint (TMJ) dysfunction by anteriorly displacing the mandible . In addition, other factors such as degree of muscle relaxation leading to hypotonicity of jaw muscles and passive mouth opening. In addition, for the duration of the operation the mouth is kept slightly open by a breathing tube may result in (TMJ) dislocation.
The inter-incisor distance will be measured using a Therabite â ruler (ATOS Medical, Nottingham, UK). This has a scale from 0 to 70 mm with 1-mm markings. The accuracy of this type of ruler is1.0 mm. The Therabite ruler was chosen as it routinely used by the investigators for (TMJ) assessment in the maxillofacial clinic.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supra glottic airway devices | Other | Device: Supra glottic airway devices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Patient refusal
- limited mouth opening(<2 fingers)
- Facial \&upper airway trauma
- Patients with dentures or who were edentulous (as accurate objective measurements would be difficult to determine)
- Head and neck surgery (as surgery may influence TMJ function)
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 |
|---|---|---|
| Supra glottic airway devicesUsing the device in save air way in patients under general anesthesia and the change in the tempromandibular joint will be evaluated | Device | Supra glottic airway devices |
Primary outcome
Change in tempromandibular jiont function
Time frame: Single measurement Within 24 hours postoperative
The change in inter incisors distance,forword movement\&lat movement of the jow post operative will be measured also any post op pain or difficulty in movement of the jow will be recorded
1 secondary outcome
Other complications of supraglottic airway devices
Time frame: Intra operative &24hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Supra glottic airway devices in people with Change of Tempromandibular Joint Function With Supra Glottic Airway Devices, run by Sohag University.
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 0 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Change in tempromandibular jiont function (time frame: Single measurement Within 24 hours postoperative). 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 24 Jan 2022.