Muscle wasting and swallowing problems in critically ill adults
The Relationship Between Oral and Suprahyoid Muscle Wasting and Dysphagia in Critically Ill Patients
Barts & The London NHS Trust · NCT07076524
This project will try to see if wasting of mouth and throat muscles in adults in intensive care leads to problems with swallowing.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Barts & The London NHS Trust (other) |
| Locations | 1 site (London) |
| Trial ID | NCT07076524 on ClinicalTrials.gov |
What this trial studies
This observational study will use bedside ultrasound to measure cross-sectional area and changes over time in oral and suprahyoid muscles at four time points during critical care and hospital stay. Tongue strength, high-definition surface electromyography of swallowing muscles, and standardized tests of swallowing safety and physiology will also be performed, along with patient-reported swallowing and eating outcomes. Critically ill participants on mechanical ventilation will be compared with non-critically ill ward-based control participants, and rectus femoris measurements will be used as a reference for general muscle wasting. The goal is to link muscle wasting patterns in the mouth and throat to objective and patient-reported measures of dysphagia.
Who should consider this trial
Good fit: Adults over 18 who are receiving mechanical ventilation via endotracheal tube or tracheostomy, expected to require ventilation for at least 72 hours and to remain in the ICU for more than 7 days are the ideal candidates.
Not a fit: People with pre-existing neuromuscular or central nervous system disease, head and neck cancer or prior head/neck surgery or radiotherapy, connective tissue disease, or pregnancy are excluded and would not be expected to benefit directly from this study's findings.
Why it matters
Potential benefit: If successful, the findings could help identify ICU patients at high risk of dysphagia earlier and guide targeted rehabilitation to reduce aspiration, malnutrition, and longer hospital stays.
How similar studies have performed: Previous work has linked general ICU-acquired muscle wasting to poor swallowing outcomes and some small studies used ultrasound and tongue-strength measures, but prospectively relating oral and suprahyoid muscle wasting specifically to dysphagia in critically ill adults is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Control participants * Adults \>18 years * Receiving ward-based care. * Expected to survive hospital admission. Present with a primary medical diagnosis of acute medical or surgical illness, not requiring critical care admission. Exclusion Criteria: Applies to both critically ill and control participants. * 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.
Where this trial is running
London
- Royal London Hospital — London, United Kingdom (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Critical Illness, Dysphagia, Muscle Wasting in Critically Ill, Swallowing Disorders, dysphagia, critical illness, swallowing disorders, muscle wasting