MuScle WastIng and DysphaGia iN CriticAlly IlL Patients (SIGNAL)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBarts & The London NHS Trust
About this trial
The goal of this study is to find out how muscle wasting in the mouth and throat affects swallowing (dysphagia) in adults who are critically ill and being treated in intensive care units.
The main aims of this research study are to understand: how much and how quickly the oral and suprahyoid muscles waste in critically ill participants, and whether muscle wasting causes problems with swallowing. The investigators will compare critically ill participants with non-critically ill participants to determine if muscle wasting is linked to swallowing problems.
In this study, participants will have the size and strength of their mouth and throat muscles measured at four different times during their critical care admission and hospital stay. Tests will also be performed to check how well and how safely participants can swallow. Tongue strength will be measured, and participants will answer questions about their experience with swallowing and eating using patient-reported outcome measures.
This study may help identify better ways to diagnose and treat swallowing problems in people who are critically ill, to support safe eating and drinking and promote faster recovery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults >18 years
Receiving mechanical ventilation via endotracheal tube and/or tracheostomy. Expected to receive ventilation for at least 72 hours.
Expected to survive admission and spend more than 7 days in the intensive care unit.
Adults >18 years
Disqualifiers
Pregnancy
Patients with a diagnosis of a primary neuromuscular pathology (e.g., motor neurone disease), central nervous system disease (e.g., stroke, Guillain barre), traumatic brain injury, connective tissue disease (e.g., scleroderma), head and neck cancer, previous surgery or radiotherapy to the head and neck.
Trial population
Critically ill patients and non-critically ill patients
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Measure the extent and rate of muscle wasting
To measure the extent and rate of change in cross-sectional area of the oral and suprahyoid muscles in critically ill adults using bedside ultrasound across four time points. The extent and rate of muscle wasting will be assessed by measuring the change in cross-sectional area (mm²) of the oral and suprahyoid muscles using bedside ultrasound.
Time frame
Day 1, 3, 7 and 10 of intensive care unit admission2
Relate muscle wasting to swallow physiology and safety
To correlate changes in cross-sectional area to swallow physiology and safety in critically ill patients, using instrumental swallowing evaluations and tongue strength. To quantify the change in size of the oral and suprahyoid muscles, the cross-sectional area (mm²) will be measured using bedside ultrasound. Swallowing physiology and safety will be assessed using instrumental swallowing evaluations (e.g., Fiberoptic Endoscopic Evaluation of Swallowing (FEES)).The correlation coefficient (e.g., Pearson's or Spearman's r) between ultrasound-measured muscle cross-sectional area and instrumental swallowing assessment scores (e.g., the Penetration Aspiration Scale) will be used.
Time frame
Following day 10 ultrasound or when the patient is extubated and clinically appropriate for swallow assessmentSecondary outcomes
1
Measure electrophysiological features of swallow muscle activity
To measure the electrophysiological features of swallowing muscles using high definition surface electromyography in critically ill and non-critically ill patients. Electrophysiological features of swallowing-related muscles will be measured. Parameters will include average root mean square amplitude, symmetry of muscle activation, and duration of muscle activity during swallowing tasks.
Time frame
Day 1, 3, 7 and 10 of intensive care unit admission2
Compare relationship between muscle mass and swallow physiology
To compare the relationship between muscle mass and swallow physiology in critically ill patients and non-critically ill patients. The correlation between muscle mass and swallow physiology will be assessed. Muscle mass will be measured using ultrasound cross-sectional area (cm²) of the oral and suprahyoid muscles at four time points: Day 1, Day 3, Day 7, and Day 10 of ICU admission. Swallow physiology will be evaluated using instrumental evaluation (e.g., flexible endoscopic evaluation of swallow) and the following scales: Penetration-Aspiration Scale, Yale Pharyngeal Residue Severity Rating Scale and the Dynamic Imaging Grade of Swallow Toxicity) whichever occurs first, and when the patient is deemed clinically appropriate for assessment. The primary outcome will be the correlation coefficient (e.g., Pearson's or Spearman's r) between ultrasound-measured muscle mass (cm²) and swallow physiology scores.
Time frame
Day 1, 3, 7 and 10 ultrasound assessments, swallow evaluation completed following day 10 ultrasound or when patient is extubated and clinically appropriate3
Patient reported outcomes: Sydney Swallow Questionnaire
Patient-reported severity of dysphagia symptoms will be assessed using the Sydney Swallow Questionnaire (SSQ), with the total score ranging from 0 to 1700, where higher scores indicate greater symptom severity.
Time frame
Within two weeks of day 10 ultrasound measurement or when clinically appropriate (e.g., ICU delirium resolved if present), up to 1 month4
Patient reported outcomes: Swallowing Quality of Life (SWAL-QoL) Score
Patient-reported swallowing-related quality of life will be assessed using the Swallowing Quality of Life (SWAL-QoL) questionnaire, a 44-item instrument producing a total score from 0 to 100, where higher scores reflect better quality of life.
Time frame
Within two weeks of day 10 ultrasound measurement or when clinically appropriate (e.g., ICU delirium resolved if present), up to 1 monthSponsors and contacts
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Source ClinicalTrials.gov