Mechanical VentilationNCT07606690
The Geniohyoid Muscle in Critical Illness
An observational study of Mechanical Ventilation, run by Warrington Hospital at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2026to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
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.
Who may be able to join
- · 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
Who cannot join
- · 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Intensive Care Unit
Warrington, WA5 1QG
Peter Turton, MBChB (Hons) MPhil FRCA FFICM, 01925 635911 ext. 5594, peter.turton1@nhs.net
About this study
Official title: Assessing the Feasibility and Reliability of an Ultrasound-based Method of Measuring the Geniohyoid Muscle in Mechanically Ventilated Patients - an Observational Study
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.
Read more
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:
- How many patients scanned produced images that could be measured?
- How consistent are the measurements if one person measures the same muscle twice?
- If two people measure the same muscle, do their measurements agree with each other?
The patients will be under sedation when they take part in the study. Because of this, they cannot consent to take part in the study. The patient's next of kin or carer would advise on whether the patient would want to take part. When the patient is awake and has the breathing tube removed, the research team would ask them to sign a consent form to use their data.
Read the detailed description
Introduction
Many patients who are mechanically ventilated due to critical illness have difficulty in swallowing after the endotracheal tube is removed, a phenomenon known as Post Extubation Dsyphagia (PED). Although multifactorial, atrophy of the swallowing muscles is a potential cause.
Ultrasound is a commonly used investigative modality for the measurement of muscles in critically unwell patients. Measurements can be performed repeatedly over time to track changes in muscle size during the course of a patient's admission. In critically unwell patients, much of the research is focussed on muscles of the limbs and trunk. The muscles of swallowing have been measured using ultrasound, but in awake patients adopting an optimal seated position. Critically unwell patients are bedbound, and the endotracheal tube leaves their mouth in an open position. Before embarking on a study using ultrasound to attempt to track changes in muscle size in the muscles of swallowing, the investigators first wish to assess if such a method is both feasible and reliable.
Methods
Critically unwell patients who are sedated and mechanically ventilated will be recruited into the study after discussion with a patient's personal consultee. The geniohyoid (GH) muscle will be scanned in both the coronal and sagittal planes. The patient will be scanned three times. Twice by one assessor, and once by a second assessor. Cross sectional areas (CSA) of GH will be measured at a later time using image processing software (ImageJ, NIH, USA). Echogenicity, a measurement of the brightness of muscle on ultrasound, will also be assessed.
Results
The primary outcome is to obtain the proportion of patients whose images from ultrasound can provide satisfactory measurement data, in each plane. Furthermore, we will assess the repeatability of each measurement by calculating the intra-rater agreement, and the inter-rater agreement to assess agreement between assessors. An estimate of the mean CSA in each plane will be calculated.
Conclusions
This preliminary data will give us an estimate of the proportion of patients who can provide satisfactory images of GH, in preparation for a larger study assessing longitudinal changes in CSA. Further, the study will give data on both the inter- and intra-rather agreement of the method.
- Conditions
- Mechanical Ventilation
- Keywords
- mechanical ventilation, ultrasound, swallowing, geniohyoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mechanically ventilated patient group | Any eligible patient who is being mechanically ventilated in the site's intensive care unit, via an endotracheal tube. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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%.
Measured: 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
In this outcome, investigator A will take 3 images (set A) of the geniohyoid muscle in the coronal plane. After a short break, a second set of 3 images (set B) will be taken. Intra-rater agreement will be assessed by comparing mean and standard deviation of both set A and B, and calculating the intra-class correlation co-efficient for consistency.
Measured: Day 1
Intra-rater agreement, cross sectional area of geniohyoid muscle, sagittal plane
In this outcome, investigator A will take 3 images (set A) of the geniohyoid muscle in the sagittal plane. After a short break, a second set of 3 images (set B) will be taken. Intra-rater agreement will be assessed by comparing mean and standard deviation of both set A and B, and calculating the intra-class correlation co-efficient for consistency.
Measured: Day 1
Inter-rater agreement, cross sectional area of geniohyoid muscle, coronal plane
In this outcome, investigator A will take 3 images (set A) of the geniohyoid muscle in the coronal plane. After a short break, investigator B will take a second set of 3 images (set C) Intra-rater agreement will be assessed by comparing mean and standard deviation of both set A and C, and calculating the intra-class correlation co-efficient for agreement.
Measured: Day 1
Inter-rater agreement, cross sectional area of geniohyoid muscle, sagittal plane
In this outcome, investigator A will take 3 images (set A) of the geniohyoid muscle in the coronal plane. After a short break, investigator B will take a second set of 3 images (set C) Intra-rater agreement will be assessed by comparing mean and standard deviation of both set A and C, and calculating the intra-class correlation co-efficient for agreement.
Measured: Day 1
Intra-rater agreement, echogenicity of the geniohyoid muscle, sagittal plane
Investigator A will have taken 2 sets of 3 images (sets A and B) of the geniohyoid muscle in the sagittal plane. Echogenicity will be measured offline using appropriate imaging software (Image J, NIH) and compared by mean and standard deviation, and by intra-class correlation coefficient for consistency.
Measured: Day 1
Inter-rater agreement, echogenicity of the geniohyoid muscle, sagittal plane
Investigator A will have taken 2 sets of 3 images (sets A and B) of the geniohyoid muscle in the sagittal plane, and investigator B will take set of 3 images (set C). Echogenicity will be measured offline using appropriate imaging software (Image J, NIH) and compared by mean and standard deviation, and by intra-class correlation coefficient for absolute agreement.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Warrington Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Turton, Warrington Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606690
- Sponsor's protocol ID
- W0001
- Other IDs
- 26/NW/0011
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility and Reliability of an Ultrasound-based Method of Measuring the Geniohyoid Muscle in Mechanically Ventilated Patients - an Observational Study
- ClinicalTrials.gov ID
- NCT07606690
- Acronym / sponsor ID
- W0001
- Conditions
- Mechanical Ventilation
- Keywords
- mechanical ventilation, ultrasound, swallowing, geniohyoid
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Warrington HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 26 May 2026 (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.
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:
- How many patients scanned produced images that could be measured?
- How consistent are the measurements if one person measures the same muscle twice?
- If two people measure the same muscle, do their measurements agree with each other?
The patients will be under sedation when they take part in the study. Because of this, they cannot consent to take part in the study. The patient's next of kin or carer would advise on whether the patient would want to take part. When the patient is awake and has the breathing tube removed, the research team would ask them to sign a consent form to use their data.
Detailed description
Introduction
Many patients who are mechanically ventilated due to critical illness have difficulty in swallowing after the endotracheal tube is removed, a phenomenon known as Post Extubation Dsyphagia (PED). Although multifactorial, atrophy of the swallowing muscles is a potential cause.
Ultrasound is a commonly used investigative modality for the measurement of muscles in critically unwell patients. Measurements can be performed repeatedly over time to track changes in muscle size during the course of a patient's admission. In critically unwell patients, much of the research is focussed on muscles of the limbs and trunk. The muscles of swallowing have been measured using ultrasound, but in awake patients adopting an optimal seated position. Critically unwell patients are bedbound, and the endotracheal tube leaves their mouth in an open position. Before embarking on a study using ultrasound to attempt to track changes in muscle size in the muscles of swallowing, the investigators first wish to assess if such a method is both feasible and reliable.
Methods
Critically unwell patients who are sedated and mechanically ventilated will be recruited into the study after discussion with a patient's personal consultee. The geniohyoid (GH) muscle will be scanned in both the coronal and sagittal planes. The patient will be scanned three times. Twice by one assessor, and once by a second assessor. Cross sectional areas (CSA) of GH will be measured at a later time using image processing software (ImageJ, NIH, USA). Echogenicity, a measurement of the brightness of muscle on ultrasound, will also be assessed.
Results
The primary outcome is to obtain the proportion of patients whose images from ultrasound can provide satisfactory measurement data, in each plane. Furthermore, we will assess the repeatability of each measurement by calculating the intra-rater agreement, and the inter-rater agreement to assess agreement between assessors. An estimate of the mean CSA in each plane will be calculated.
Conclusions
This preliminary data will give us an estimate of the proportion of patients who can provide satisfactory images of GH, in preparation for a larger study assessing longitudinal changes in CSA. Further, the study will give data on both the inter- and intra-rather agreement of the method.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanically ventilated patient group | – | –Any eligible patient who is being mechanically ventilated in the site's intensive care unit, via an endotracheal tube. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- · Mechanically ventilated patient on the intensive care unit
Key exclusion criteria (11 listed)
- · Ventilated via a nasal endotracheal tube
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Satisfactory image acquisition of the geniohyoid muscle in the coronal plane (n, proportion)
Time frame: Day 1 (patients are only on the day of the ultrasound)
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%.
Satisfactory image acquisition of the geniohyoid muscle, sagittal plane (n, proportion)
Time frame: Day 1 - patients are only in the study on the day of the ultrasound scan
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%.
6 secondary outcomes
Intra-rater agreement, cross sectional area of geniohyoid muscle, coronal plane
Time frame: Day 1
Intra-rater agreement, cross sectional area of geniohyoid muscle, sagittal plane
Time frame: Day 1
Inter-rater agreement, cross sectional area of geniohyoid muscle, coronal plane
Time frame: Day 1
Inter-rater agreement, cross sectional area of geniohyoid muscle, sagittal plane
Time frame: Day 1
Intra-rater agreement, echogenicity of the geniohyoid muscle, sagittal plane
Time frame: Day 1
Inter-rater agreement, echogenicity of the geniohyoid muscle, sagittal plane
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be made available upon reasonable request.
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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.
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 Mechanical Ventilation, run by Warrington Hospital at 1 site in United Kingdom.
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 3 inclusion and 11 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: opening soon, as of the sponsor's last update on 28 May 2026. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfactory image acquisition of the geniohyoid muscle in the coronal plane (n, proportion) (time frame: Day 1 (patients are only on the day of the ultrasound)). The study lists 2 primary outcomes in all. 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 May 2026.