DysphagiaNCT07787312
Masseter and Rectus Femoris Ultrasound for Dysphagia and Sarcopenia in Critically Ill Patients
An observational study of Dysphagia and Sarcopenia, run by Sara Casanova Prieto at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Sarcopenia
- How many people
- 323 participants
- Where
- 1 siteSpain
- Study dates
- 3 Feb 2026to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
SARA CASANOVA PRIETO, MD, +34665286063, sara.casanova@salud.madrid.org
About this study
Official title: Diagnostic Accuracy of Masseter and Rectus Femoris Muscle Ultrasound for the Diagnosis of Dysphagia and Sarcopenia in Critically Ill Patients
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
- Medical subject headings
- Deglutition Disorders, Sarcopenia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The proportion of participants with dysphagia will be determined using the modified Volume-Viscosity Swallow Test (MECVVm). Dysphagia occurrence will be assessed separately in extubated critically ill patients and critically ill patients with a tracheostomy.
Measured: 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
Demographic, clinical, severity-of-illness, mechanical ventilation, airway management, neurological, nutritional, and functional variables collected during the ICU stay will be analyzed to identify factors independently associated with dysphagia, as determined by the modified Volume-Viscosity Swallow Test (MECVVm), in extubated and tracheostomized critically ill patients.
Measured: From ICU admission to the time of dysphagia assessment, up to 4 months
Ability of Masseter Muscle Ultrasound to Identify Risk of Sarcopenia
The ability of masseter muscle ultrasound to identify critically ill patients at risk of sarcopenia will be evaluated by comparing masseter muscle thickness with ultrasound measurements of the rectus femoris muscle.
Measured: 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
Receiver operating characteristic (ROC) curve analysis will be used to determine optimal cut-off values for masseter and rectus femoris muscle thickness for discriminating dysphagia and sarcopenia in critically ill patients. Diagnostic performance will be assessed using sensitivity, specificity, positive and negative predictive values, and the Youden index.
Measured: At dysphagia assessment, up to 4 months after ICU admission.
Association of Dysphagia and Sarcopenia With Clinical Outcomes
The association between dysphagia and sarcopenia, as assessed by the study procedures, and relevant clinical outcomes will be evaluated. Clinical outcomes include ICU length of stay, nutritional complications, and mortality.
Measured: From ICU admission through 6 months after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start3 Feb 2026
- Primary completionDec 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 323 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sara Casanova Prieto
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
- Responsible party
- Sponsor-investigator, Sara Casanova Prieto, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787312
- Sponsor's protocol ID
- MM-RF-DYS-ICU-01
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared due to participant confidentiality and data protection requirements. Aggregated and anonymized study results will be reported in scientific publications and presentations.
Publications
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.
PubMed 28820608Martinez 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.
PubMed 36657916Gonzalez-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.
PubMed 34573928Gonzalez-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.
PubMed 33462765
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Masseter and Rectus Femoris Muscle Ultrasound for the Diagnosis of Dysphagia and Sarcopenia in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07787312
- Acronym / sponsor ID
- MM-RF-DYS-ICU-01
- Conditions
- Dysphagia, Sarcopenia
- Keywords
- Post-extubation dysphagia, Masseter muscle, Rectus femoris muscle, Muscle ultrasound, Critical illness, Intensive care unit, MECV-V, Muscle mass
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 323 participants (estimated)
- Lead sponsor
- Sara Casanova PrietoUniversity, hospital or other
- Collaborators
- Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association Between Masseter Muscle Thickness and Dysphagia
Time frame: 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.
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.
5 secondary outcomes
Occurrence of Dysphagia in Critically Ill Patients
Time frame: 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
Time frame: From ICU admission to the time of dysphagia assessment, up to 4 months
Ability of Masseter Muscle Ultrasound to Identify Risk of Sarcopenia
Time frame: 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
Time frame: At dysphagia assessment, up to 4 months after ICU admission.
Association of Dysphagia and Sarcopenia With Clinical Outcomes
Time frame: From ICU admission through 6 months after ICU discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 28820608Mourtzakis 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.
- Background: PubMed 36657916Martinez 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.
- Background: PubMed 34573928Gonzalez-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.
- Background: PubMed 33462765Gonzalez-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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared due to participant confidentiality and data protection requirements. Aggregated and anonymized study results will be reported in scientific publications and presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia and Sarcopenia, run by Sara Casanova Prieto at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SARA CASANOVA PRIETO, MD (+34665286063, sara.casanova@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Masseter Muscle Thickness and Dysphagia (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07787312, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.