RecruitingNot Applicable

MuScle WastIng and DysphaGia iN CriticAlly IlL Patients (SIGNAL)

United Kingdom160 participantsStarted 2025-08-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measure the extent and rate of muscle wasting

Timeframe: Day 1, 3, 7 and 10 of intensive care unit admission

Relate muscle wasting to swallow physiology and safety

Timeframe: Following day 10 ultrasound or when the patient is extubated and clinically appropriate for swallow assessment

Trial details

NCT IDNCT07076524

SponsorBarts & The London NHS Trust

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-01-31

View on ClinicalTrials.gov More Critical Illness trials