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The Geniohyoid Muscle in Critical Illness

22 мая 2026 г. обновлено: Peter Turton, Warrington Hospital

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.

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. How many patients scanned produced images that could be measured?
  2. How consistent are the measurements if one person measures the same muscle twice?
  3. 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.

Обзор исследования

Статус

Еще не набирают

Условия

Подробное описание

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.

Тип исследования

Наблюдательный

Регистрация (Оцененный)

30

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Метод выборки

Невероятностная выборка

Исследуемая популяция

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.

Описание

Inclusion Criteria:

  • · 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

Exclusion Criteria:

  • · 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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

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

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Satisfactory image acquisition of the geniohyoid muscle in the coronal plane (n, proportion)
Временное ограничение: 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%.
Day 1 (patients are only on the day of the ultrasound)
Satisfactory image acquisition of the geniohyoid muscle, sagittal plane (n, proportion)
Временное ограничение: 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%.
Day 1 - patients are only in the study on the day of the ultrasound scan

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Intra-rater agreement, cross sectional area of geniohyoid muscle, coronal plane
Временное ограничение: Day 1
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.
Day 1
Intra-rater agreement, cross sectional area of geniohyoid muscle, sagittal plane
Временное ограничение: Day 1
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.
Day 1
Inter-rater agreement, cross sectional area of geniohyoid muscle, coronal plane
Временное ограничение: Day 1
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.
Day 1
Inter-rater agreement, cross sectional area of geniohyoid muscle, sagittal plane
Временное ограничение: Day 1
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.
Day 1
Intra-rater agreement, echogenicity of the geniohyoid muscle, sagittal plane
Временное ограничение: Day 1
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.
Day 1
Inter-rater agreement, echogenicity of the geniohyoid muscle, sagittal plane
Временное ограничение: Day 1
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.
Day 1

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Warrington Hospital

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 июня 2026 г.

Первичное завершение (Оцененный)

1 января 2027 г.

Завершение исследования (Оцененный)

1 июня 2027 г.

Даты регистрации исследования

Первый отправленный

18 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

18 мая 2026 г.

Первый опубликованный (Действительный)

26 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

28 мая 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

22 мая 2026 г.

Последняя проверка

1 мая 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Другие идентификационные номера исследования

  • W0001
  • 26/NW/0011 (Другой идентификатор: REC - North West Greater Manchester South)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

All IPD that underlie results in a publication will be made available upon reasonable request.

Сроки обмена IPD

At any point after the cessation of the study.

Критерии совместного доступа к IPD

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.

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • МКФ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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