Masseter and Rectus Femoris Ultrasound for Dysphagia and Sarcopenia in Critically Ill Patients

NCT07787312 | Recruiting

• 1 other identifier: MM-RF-DYS-ICU-01
• Study Type: observational
• Target: 323
• Locations: 1 country
• Sites: 1

Brief Summary

Dysphagia and sarcopenia are common complications in critically ill patients and are associated with increased morbidity, prolonged hospitalization, nutritional complications, and poorer clinical outcomes. Muscle ultrasound is a non-invasive bedside technique that may provide objective information on muscle mass and help identify patients at increased risk of these conditions. This single-center observational diagnostic accuracy study will evaluate the association between masseter muscle thickness measured by ultrasound and the presence of dysphagia in critically ill adult patients after extubation and in patients with a tracheostomy. Dysphagia will be assessed using the Modified Volume-Viscosity Swallow Test (MECVVm). Ultrasound measurements of the masseter and rectus femoris muscles will also be evaluated to investigate their relationship with sarcopenia and relevant clinical outcomes. The study aims to determine the diagnostic performance of masseter muscle ultrasound for identifying dysphagia, establish ultrasound cut-off values associated with dysphagia and sarcopenia, and explore whether these measurements may facilitate early risk stratification in critically ill patients.

Conditions

Dysphagia; Sarcopenia

Keywords

Post-extubation dysphagia; Masseter muscle; Rectus femoris muscle; Muscle ultrasound; Critical illness; Intensive care unit; MECV-V; Muscle mass

Outcome Measures

Primary Outcomes (1)

• Association Between Masseter Muscle Thickness and Dysphagia

  Maximum masseter muscle thickness will be measured by ultrasound and its association with the presence of dysphagia will be assessed. Dysphagia will be determined using the modified Volume-Viscosity Swallow Test (MECVVm). The association will be evaluated separately in extubated critically ill patients and critically ill patients with a tracheostomy.

  At the time of dysphagia assessment: 6 to 36 hours after extubation in extubated patients, or once tracheostomized patients tolerate at least 6 hours/day of spontaneous breathing without mechanical ventilation.

Secondary Outcomes (5)

• Occurrence of Dysphagia in Critically Ill Patients

  At the time of dysphagia assessment: 6 to 36 hours after extubation in extubated patients, or once tracheostomized patients tolerate at least 6 hours/day of spontaneous breathing without mechanical ventilation.

• Risk Factors Associated With Dysphagia

  From ICU admission to the time of dysphagia assessment, up to 4 months

• Ability of Masseter Muscle Ultrasound to Identify Risk of Sarcopenia

  At 48 hours after invasive mechanical ventilation and at dysphagia assessment (6-36 hours after extubation or, in tracheostomized patients, when tolerating at least 6 hours/day without mechanical ventilation), up to 4 months after ICU admission.

• Ultrasound Cut-off Values for Dysphagia and Sarcopenia

  At dysphagia assessment, up to 4 months after ICU admission.

• Association of Dysphagia and Sarcopenia With Clinical Outcomes

  From ICU admission through 6 months after ICU discharge

Study Arms (2)

Extubated Critically Ill Patients

Adult critically ill patients who received invasive mechanical ventilation for at least 48 hours and are assessed after extubation. Participants undergo masseter and rectus femoris muscle ultrasound and dysphagia assessment using the modified Volume-Viscosity Swallow Test (MECVVm) according to the study protocol.

Tracheostomized Critically Ill Patients

Adult critically ill patients with a tracheostomy who meet the study eligibility criteria. Participants undergo masseter and rectus femoris muscle ultrasound and dysphagia assessment using the modified Volume-Viscosity Swallow Test (MECVVm) according to the study protocol.

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

Adult critically ill patients admitted to the Intensive Care Unit of Hospital General Universitario Gregorio Marañón who require invasive mechanical ventilation for more than 48 hours. The study population includes patients assessed after extubation and patients with a tracheostomy who meet the predefined eligibility criteria and are clinically suitable for dysphagia assessment.

You may qualify if:

• Age ≥18 years.
• Critically ill patients requiring invasive mechanical ventilation for \>48 hours.
• Extubated patients: extubation 6-36 hours before study assessment.
• Tracheostomized patients: surgical or percutaneous tracheostomy considered clinically suitable to initiate oral feeding, tolerating spontaneous breathing without mechanical ventilation for at least 6 hours/day, and negative cuff-leak test.
• Awake and cooperative, with effective cough and ability to manage oral secretions.
• Written informed consent obtained.

You may not qualify if:

• Documented pre-existing oropharyngeal dysphagia.
• Inability to undergo study assessment within 36 hours after extubation.
• In tracheostomized patients, positive cuff-leak test before study assessment.

Sponsors & Collaborators

• Sara Casanova Prieto: lead
• Fundación para la Investigación Biomédica del Hospital Gregorio Maranon: collaborator

Study Sites (1)

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

RECRUITING

Related Publications (4)

• Mourtzakis M, Parry S, Connolly B, Puthucheary Z. Skeletal Muscle Ultrasound in Critical Care: A Tool in Need of Translation. Ann Am Thorac Soc. 2017 Oct;14(10):1495-1503. doi: 10.1513/AnnalsATS.201612-967PS.

  PMID: 28820608 BACKGROUND

• Martinez de Lagran Zurbano I, Laguna LB, Soria CV, Guisasola CP, Marcos-Neira P. Utility of the modified Volume-Viscosity Swallow Test for bedside screening of dysphagia in critically ill patients. Clin Nutr ESPEN. 2023 Feb;53:214-223. doi: 10.1016/j.clnesp.2022.12.021. Epub 2022 Dec 23.

  PMID: 36657916 BACKGROUND

• Gonzalez-Fernandez M, Perez-Nogueras J, Serrano-Oliver A, Torres-Anoro E, Sanz-Arque A, Arbones-Mainar JM, Sanz-Paris A. Masseter Muscle Thickness Measured by Ultrasound as a Possible Link with Sarcopenia, Malnutrition and Dependence in Nursing Homes. Diagnostics (Basel). 2021 Aug 31;11(9):1587. doi: 10.3390/diagnostics11091587.

  PMID: 34573928 BACKGROUND

• Gonzalez-Fernandez M, Arbones-Mainar JM, Ferrer-Lahuerta E, Perez-Nogueras J, Serrano-Oliver A, Torres-Anoro E, Sanz-Paris A. Ultrasonographic Measurement of Masseter Muscle Thickness Associates with Oral Phase Dysphagia in Institutionalized Elderly Individuals. Dysphagia. 2021 Dec;36(6):1031-1039. doi: 10.1007/s00455-020-10234-8. Epub 2021 Jan 19.

  PMID: 33462765 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders; Sarcopenia; Critical Illness

Condition Hierarchy (Ancestors)

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

Central Study Contacts

SARA CASANOVA PRIETO, MD

CONTACT

+34665286063; sara.casanova@salud.madrid.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 26, 2026
• Study Start: February 3, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)