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Status unknownNCT05204914Updated Jan 24, 2022

Effect Of Supraglottic Airway Devices On The Tempromandibular Joint Function Following Prolonged General Anesthesia

An interventional study of Supra glottic airway devices in Change of Tempromandibular Joint Function With Supra Glottic Airway Devices, sponsored by Sohag University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-24.

Sponsored by Sohag University · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Change of Tempromandibular Joint Function With Supra Glottic Airway Devices

Keywords

  • The interincisors distance& movements of the jaw
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In context

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion The study will include 60 adult patients (>18 years old) with ASA physical status class I and class II scheduled for elective surgery under general anesthesia where SADs ara planned to be used as airway devices

Exclusion Criteria:

  1. Patient refusal
  2. limited mouth opening(\<2 fingers)
  3. Facial \&upper airway trauma
  4. Patients with dentures or who were edentulous (as accurate objective measurements would be difficult to determine)
  5. Head and neck surgery (as surgery may influence TMJ function)
  6. GITsurgery (as SAD doesn't completely protect air way against aspiration )
  7. Pt with preexisting tempromadibular joint dysfunction
  8. Duration of anaethesia less than 1 h or more than 4hs-
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Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Other
    Supra glottic airway devices

    Device: Supra glottic airway devices

Interventions

  • DeviceSupra glottic airway devices

    Using the device in save air way in patients under general anesthesia and the change in the tempromandibular joint will be evaluated

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Single measurement Within 24 hours postoperative

Secondary outcomes

  1. Other complications of supraglottic airway devices

    Including aspiration and airway edema

    Time frame: Intra operative &24hours postoperative

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05204914
Lead sponsor
Sohag University
Responsible party
Aya mohammed el_otafey (Principal investigator, Sohag University) — Principal investigator
First posted
Jan 24, 2022
Start date
Jan 30, 2022 (estimated)
Primary completion
Jun 30, 2022 (estimated)
Completion
Dec 30, 2022 (estimated)
Last update
Jan 24, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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