MuScle WastIng and DysphaGia iN CriticAlly IlL Patients (SIGNAL)

NCT07076524 | Recruiting

• 2 other identifiers: 348596G-002784
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Illness; Dysphagia; Muscle Wasting in Critically Ill; Swallowing Disorders

Keywords

dysphagia; critical illness; swallowing disorders; muscle wasting

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (7)

• Measure electrophysiological features of swallow muscle activity

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

• Compare relationship between muscle mass and swallow physiology

  Day 1, 3, 7 and 10 ultrasound assessments, swallow evaluation completed following day 10 ultrasound or when patient is extubated and clinically appropriate

• Patient reported outcomes: Sydney Swallow Questionnaire

  Within two weeks of day 10 ultrasound measurement or when clinically appropriate (e.g., ICU delirium resolved if present), up to 1 month

• Patient reported outcomes: Swallowing Quality of Life (SWAL-QoL) Score

  Within two weeks of day 10 ultrasound measurement or when clinically appropriate (e.g., ICU delirium resolved if present), up to 1 month

• Patient reported outcomes: Functional Oral Intake Scale

  Within two weeks of day 10 ultrasound measurement or when clinically appropriate (e.g., ICU delirium resolved if present), up to 1 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients and non-critically ill patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

Royal London Hospital

London, E1 1FR, United Kingdom

RECRUITING

MeSH Terms

Conditions

Critical Illness; Deglutition Disorders; Muscular Atrophy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: July 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

GB (1)