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A bedside ultrasound could reveal hidden swallowing risks in the ICU

NCT ID NCT07787312

Diagnosis Sponsor: Sara Casanova Prieto Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This study is testing whether a quick, non-invasive ultrasound of the jaw and thigh muscles can help identify swallowing difficulties (dysphagia) and muscle loss (sarcopenia) in critically ill patients. Researchers will measure muscle thickness with ultrasound and compare it to a standard swallowing test in adults who have recently been taken off a breathing tube or who have a tracheostomy. The goal is to see if this simple imaging tool can serve as an early warning sign for these common and serious ICU complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Muscle ultrasound (non-invasive imaging technique)
What this could lead to
If it works, this could give doctors a quick, bedside tool to catch swallowing problems and muscle loss early in ICU patients, potentially improving recovery and reducing complications.
What could go wrong
This is an observational study, so it can only show links, not prove cause and effect. The results may not apply to all ICU patients, and ultrasound measurements can vary between operators.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 323 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Critical Illness Deglutition Disorders Sarcopenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dysphagia Sarcopenia

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Hospital General Universitario Gregorio Marañón

    RECRUITING

    Madrid, Madrid, 28007, Spain

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