TMJ Dysfunction Following Use of SAD

NCT04103047 | Completed

• 1 other identifier: 262069
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to assess how the use of a breathing tube (Supraglottic Airway Device) can affect the function of the jaw joint (Temporomandibular joint) movement. This type of breathing tube is used for nearly 60% of general anaesthetics. To facilitate insertion of this breathing tube, assisted mouth opening and forward movement of the jaw are required. These movements occur at the jaw joint (temporomandibular joint). In addition, for the duration of the operation the mouth is kept slightly open by a breathing tube. There are a few case reports in the literature suggesting minor effect on the jaw joint. Therefore, we wish to study this further by evaluating the function of the jaw joint, 4 to 24 hours after the operation.

Conditions

Temporomandibular Joint Disorder Bilateral

Keywords

Temporomandibular joint disorder

Outcome Measures

Primary Outcomes (2)

• Difference between preoperative and postoperative interincisor distance in mm

  The primary outcome measure is the difference between preoperative and postoperative interincisor distance in mm. When mouth is fully opened, the distance between the incisor teeth is measured in mm. This measurement is repeated in the postoperative period between 4 to 24 hours after the surgery. The measurements will be done using TheraBite ruler (ATOS medical, Nottingham, UK). The data are compared using paired t test or Mann-Whitney U test.

  within 24 hours

• Difference between preoperative and postoperative lateral jaw movement in mm

  The difference between preoperative and postoperative lateral jaw movement in mm. Lateral movement of the lower jaw (the lateral sliding of midpoint of lower jaw in reference to midline is measured in mm. This reference is repeated in the postoperative period between 4 to 24 hours after the surgery. The measurements will be done using TheraBite ruler (ATOS medical, Nottingham, UK). The data are compared using paired t test or Mann-Whitney U test.

  within 24 hours

Secondary Outcomes (1)

• Patient reported pain in the jaw joint (temporomandibular joint)

  Within 24 hours

Study Arms (1)

SAD group

Adult surgical patients who are due to undergo general anaesthesia and requiring SAD insertion will be identified on the day of surgery.

Other: SAD

Interventions

SAD OTHER

The patients who have an SAD inserted as part of their normal Anaesthetic plan will be consented prior to their Anaesthetic and then have a questionnaire to fill out post operatively.

SAD group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit 130 patients undergoing any operation where the Anaesthetist feels the best choice of airway management device is a supraglottic airway device.

You may qualify if:

• All patients aged above 18, presenting for elective surgical procedure under general anaesthesia, where a supraglottic airway device can be used as primary airway device. This involves a group of patients presenting for day case surgical procedures.

You may not qualify if:

• Patients under the age of 18
• Patients who do not consent to being part of the study
• Patients in whom SAD is unlikely to be the primary airway device
• If a translator is not available at the time, participants who cannot reasonably read and communicate in English

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (2)

Birmingham Heartlands Hospital

Birmingham, West Midlands, B9 5SS, United Kingdom

Location

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, West Midlands, CV2 2DX, United Kingdom

Location

Related Publications (4)

• Cook TM, Woodall N, Harper J, Benger J; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 2: intensive care and emergency departments. Br J Anaesth. 2011 May;106(5):632-42. doi: 10.1093/bja/aer059. Epub 2011 Mar 29.

  PMID: 21447489 BACKGROUND

• Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10.

  PMID: 26556848 BACKGROUND

• Michalek P, Donaldson W, Vobrubova E, Hakl M. Complications Associated with the Use of Supraglottic Airway Devices in Perioperative Medicine. Biomed Res Int. 2015;2015:746560. doi: 10.1155/2015/746560. Epub 2015 Dec 13.

  PMID: 26783527 BACKGROUND

• Sia SL, Chang YL, Lee TM, Lai YY. Temporomandibular joint dislocation after laryngeal mask airway insertion. Acta Anaesthesiol Taiwan. 2008 Jun;46(2):82-5. doi: 10.1016/S1875-4597(08)60032-6.

  PMID: 18593655 BACKGROUND

Related Links

• Using the i-gel® supraglottic airway - Intersurgical
• TMJ scale

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 25, 2019
• Study Start: September 23, 2019
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within 6 months of completion of recruitment of patients.
• Access Criteria: We aim to publish our findings in an Anaesthetic journal.

Locations

GB (2)