Actively Recruiting
The Relationship Between Oral and Suprahyoid Muscle Wasting and Dysphagia in Critically Ill Patients
Led by Barts & The London NHS Trust · Updated on 2025-11-18
160
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying how muscle wasting in the mouth and throat affects swallowing difficulties (dysphagia) in critically ill adults in intensive care units. The study aims to measure the amount and speed of muscle loss in oral and suprahyoid muscles and explore whether this muscle wasting contributes to swallowing problems. The study compares critically ill patients who require mechanical ventilation with non-critically ill patients to determine if muscle loss is linked to swallowing issues. Participants will have ultrasound measurements of the tongue, geniohyoid, mylohyoid, anterior belly of digastric, and thigh muscles taken at four times during their ICU stay. Swallowing function will be assessed using standard instrumental tests like videofluoroscopy or fiberoptic endoscopic evaluation. Tongue strength will be measured with a dynamometer, and muscle activity will be recorded using surface electromyography. Participants will also complete questionnaires about their swallowing, eating, and quality of life. During the study, muscle size and swallowing function will be evaluated repeatedly over time, alongside patient-reported outcomes. Data will be carefully managed and monitored for quality. The main outcomes include muscle wasting extent and rate, and how these relate to swallowing safety and physiology. Secondary measures include electrophysiological features of swallowing muscles, comparisons between critically ill and control patients, and patient experiences. The study involves minimal risk and lasts through the ICU stay and hospital admission periods.
CONDITIONS
Brief Title
MuScle WastIng and DysphaGia iN CriticAlly IlL Patients (SIGNAL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults older than 18 years
- Receiving mechanical ventilation via endotracheal tube and/or tracheostomy, expected to require ventilation for at least 72 hours
- Expected to survive admission and spend more than 7 days in the intensive care unit
- Control participants: Adults older than 18 years
- Control participants: Receiving ward-based care
- Control participants: Expected to survive hospital admission with a primary acute medical or surgical diagnosis not requiring critical care admission
You will not qualify if you...
- Pregnancy
- Diagnosis of primary neuromuscular pathology such as motor neurone disease
- Diagnosis of central nervous system disease such as stroke or Guillain-Barré syndrome
- Traumatic brain injury
- Connective tissue disease such as scleroderma
- Head and neck cancer
- Previous surgery or radiotherapy to the head and neck
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 days during intensive care unit admission
Participants in the intensive care unit will undergo repeated non-invasive ultrasound assessments of oral, suprahyoid, and thigh muscles to measure muscle wasting and swallowing function. Additional swallowing evaluations and electrophysiological assessments will also be performed during the ICU stay.
4 visits on Days 1, 3, 7, and 10 (in-person) plus swallowing assessment following Day 10 ultrasound or when clinically appropriate
Duration - Up to 1 month after ICU discharge
After ICU discharge, participants will be asked to complete patient-reported outcome measures related to swallowing, eating, and quality of life to assess recovery.
1 to 2 visits or assessments within two weeks of Day 10 ultrasound or when clinically appropriate
Trial Site Locations
Total: 1 location
1
Royal London Hospital
London, United Kingdom, E1 1FR
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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