The Geniohyoid Muscle in Critical Illness

NCT07606690 | Not Yet Recruiting

• 2 other identifiers: W000126/NW/0011
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Many patients lose muscle due to being unwell in an intensive care unit. This muscle loss can lead to weakness of the arms and legs when they leave the unit, and when they go home. For many years investigators have measured the size of these arm and leg muscles using an ultrasound machine, to take a picture of the muscles. It is also known that patients who are on a ventilator (or "breathing machine") often have problems swallowing when the breathing tube is removed from their mouth. This may be because the muscles of swallowing may also shrink. One of these muscles sits under the jaw and can be measured with ultrasound - the method has been shown to be accurate and reliable in awake volunteers, but these volunteers are usually sat upright in a chair with their mouth closed. Before it can be assed whether these muscles get smaller, it is needed to assess whether the chosen method is suitable in patients on a ventilator; these patients are lying in bed, and their mouths are open slightly due to the breathing tube. Proposed Method This investigation will measure the size of a muscle under the jaw (called the geniohyoid muscle) in patients who are sedated and have a breathing tube in their mouth connected to a ventilator. Using a normal hospital ultrasound machine, one researcher will place the ultrasound probe under the patient's jaw. When the researcher is happy the probe is in the right place, they will take a picture of the muscle and measure its size and thickness. After a short break, the researcher will repeat this process. After a second short break, another researcher who did not watch the first researcher will also place the probe under the jaw and take a picture of the muscle. These measurements can be used to to answer the following questions:

1. 1.How many patients scanned produced images that could be measured?
2. 2.How consistent are the measurements if one person measures the same muscle twice?
3. 3.If two people measure the same muscle, do their measurements agree with each other?

Conditions

Mechanical Ventilation

Keywords

mechanical ventilation; ultrasound; swallowing; geniohyoid

Outcome Measures

Primary Outcomes (2)

• Satisfactory image acquisition of the geniohyoid muscle in the coronal plane (n, proportion)

  To obtain an estimate for the proportion of patients in which satisfactory images can be measured, in both measured planes (coronal and sagittal views). An "unsatisfactory" image is due to either the investigator being unable to adequately visualise the GH muscle with the probe (e.g. due to subcutaneous fat, difficult patient positioning, or when an image has been obtained, the offline CSA measurement cannot be performed due to inadequate visualisation of the muscle's fascial border. In addition, the co-efficient of variance of the three images taken must be less than 5%.

  Day 1 (patients are only on the day of the ultrasound)

• Satisfactory image acquisition of the geniohyoid muscle, sagittal plane (n, proportion)

  To obtain an estimate for the proportion of patients in which satisfactory images can be measured, in the sagittal plane. An "unsatisfactory" image is due to either the investigator being unable to adequately visualise the GH muscle with the probe (e.g. due to subcutaneous fat, difficult patient positioning, or when an image has been obtained, the offline CSA measurement cannot be performed due to inadequate visualisation of the muscle's fascial border. In addition, the co-efficient of variance of the three images taken must be less than 5%.

  Day 1 - patients are only in the study on the day of the ultrasound scan

Secondary Outcomes (6)

• Intra-rater agreement, cross sectional area of geniohyoid muscle, coronal plane

  Day 1

• Intra-rater agreement, cross sectional area of geniohyoid muscle, sagittal plane

  Day 1

• Inter-rater agreement, cross sectional area of geniohyoid muscle, coronal plane

  Day 1

• Inter-rater agreement, cross sectional area of geniohyoid muscle, sagittal plane

  Day 1

• Intra-rater agreement, echogenicity of the geniohyoid muscle, sagittal plane

  Day 1

Study Arms (1)

Mechanically ventilated patient group

Any eligible patient who is being mechanically ventilated in the site's intensive care unit, via an endotracheal tube.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mechanically ventilated patients via an endotracheal tube who are admitted to the Intensive Care Unit of Warrington Hospital (North Cheshire and Mersey NHS Foundation Trust), at any time of their admission.

You may qualify if:

• · Mechanically ventilated patient on the intensive care unit
• Endotracheal tube via the mouth in-situ (size 7.0 and above)
• Can be recruited at any time during their admission

You may not qualify if:

• · Ventilated via a nasal endotracheal tube
• Ventilated via a tracheostomy
• Ventilated via a micro-endotracheal tube
• Any previous or active history of head and neck cancer
• Any previous head and neck surgery (excluding tonsillectomy and adenoidectomy)
• Any cranio-facial deformity that would render access to the jaw difficult, including but not limited to short thymo-mental distance
• Any neuromuscular disorder, including previous stroke
• Any previous history of dysphagia or swallowing disorder
• Pregnant patients
• Patients under 18 years of age
• Agitation or movement that would make measurement difficult or inaccurate

Sponsors & Collaborators

• Warrington Hospital: lead

Study Sites (1)

Intensive Care Unit

Warrington, WA5 1QG, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Intensive Care Medicine, Principal Investigator

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: At any point after the cessation of the study.
• Access Criteria: Anonymised baseline data (age, weight, height etc), and their associated measured (geniohyoid muscle cross sectional areas and echogenicities) and associated results and summary/inferential statistics will be made available on request to the corresponding author of any future publication.

Locations

GB (1)