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Search / Trial NCT06369337

Ultrasound Study of the Submentonian Musculature and Its Relationship in Dysphagia

Launched by UNIVERSIDAD EUROPEA DE MADRID · Apr 12, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Dysphagia Ultrasonography Deglutition Disorders Diagnostic Imaging Mechanical Ventilation

ClinConnect Summary

This clinical trial is investigating how certain muscles in the throat and tongue change in patients who have been on a ventilator for more than 48 hours and how these changes might relate to difficulties with swallowing, a condition known as dysphagia. Researchers will use ultrasound technology to look at the muscles involved in swallowing and see if there are any connections between the muscle changes and the development of dysphagia after patients are taken off the ventilator. The study aims to gather information about how common dysphagia is in these patients and identify any factors that might increase the risk of developing it.

To participate in this study, individuals must be over 18 years old and have been intubated (a tube placed in the throat for breathing assistance) for more than 48 hours. However, certain conditions, like previous strokes or severe nerve damage, may prevent someone from being eligible. Participants can expect to undergo assessments that measure their swallowing ability and muscle function. It’s important to note that this trial is not yet recruiting participants, so there will be no immediate action required for those interested.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • • Subjects \>18 years old.
  • Having received an episode of orotracheal intubation for \>48h
  • Exclusion Criteria:
  • • Congenital or acquired conditions of the Central Nervous System (CNS) such as stroke, traumatic brain injury, Parkinson's, multiple sclerosis, amyotrophic lateral sclerosis (ALS) or any other condition that may bias the attribution of dysphagia to factors other than exclusively clinical ones.
  • Involvement of the cranial nerves or the Peripheral Nervous System (PNS) as well as diseases of the neuromuscular junction such as Myasthenia Gravis or any other condition that may bias the attribution of dysphagia to other factors that are not exclusively clinical.
  • Neck morphology incompatible with exploration through ultrasound procedures.
  • Secondary musculoskeletal injuries, including vertebral fractures, unstable extremity fractures or any condition that requires absolute bed rest as prescribed by a doctor.
  • Malignant tumor lesions or previous head and/or neck surgeries.
  • Medical-surgical history due to pathology of the larynx, oropharynx and/or esophagus.
  • Diagnosis of dysphagia or swallowing disorders prior to the intubation episode with IMV.
  • Patients unable to eat orally, at least partially.
  • Known prior cognitive impairment upon admission to the ICU.

About Universidad Europea De Madrid

Universidad Europea de Madrid (UEM) is a leading academic institution dedicated to advancing research and education in various fields, including health sciences. As a clinical trial sponsor, UEM is committed to fostering innovative research that contributes to the understanding and improvement of medical practices. The university collaborates with healthcare professionals and researchers to design and implement rigorous clinical trials, ensuring adherence to ethical standards and regulatory guidelines. UEM's focus on interdisciplinary collaboration and cutting-edge research methodologies positions it as a pivotal player in the advancement of clinical knowledge and patient care.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported