About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

· 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

Disqualifiers

· 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

Trial 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.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

30 Participants

are grouped into 1 trial group

Group A: Mechanically ventilated patient group

Trial outcomes

Primary outcomes

1

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%.

Time frame

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

2

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%.

Time frame

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

Secondary outcomes

1

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.

Time frame

Day 1

2

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.

Time frame

Day 1

3

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.

Time frame

Day 1

4

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.

Time frame

Day 1

The Geniohyoid Muscle in Critical Illness

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial population

Trial design

Treatments tested in this trial

Trial groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

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