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Search / Trial NCT06630013

A New Ultrasound Score for Swallowing Disorders Diagnosis in Difficult-to-wean Tracheostomised Patients

Launched by HOPITAL FORCILLES · Oct 4, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to diagnose swallowing disorders in patients who have a tracheostomy and are having difficulty weaning off the ventilator. Swallowing problems, known as deglutition disorders, are common in these patients and can lead to serious health issues, including breathing problems and malnutrition. The researchers are developing an ultrasound-based diagnostic model that aims to provide a safer and more accurate way to assess swallowing difficulties compared to traditional methods, which can be invasive or hard to access.

To participate in this trial, patients must be at least 18 years old, currently in the ICU with a tracheostomy due to difficulty weaning off support, and have a medical need for a swallowing assessment. During the study, all participants will undergo a swallowing assessment using a method called Fiberoptic Endoscopic Evaluation of Swallowing (FEES), while an ultrasound examination will be performed to look at the movement of swallowing-related structures. The goal is to create a simple scoring system based on ultrasound findings that can help detect swallowing issues early and guide treatment, ultimately improving care for these patients.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients admitted to ICU and tracheostomised for difficult-to-wean reasons ;
  • Patients with a medical indication for nasofibroscopy ;
  • Medical prescription for physiotherapy assessment ;
  • Ultrasound operator available ;
  • Patient at least 18 years old at the time of inclusion;
  • Oral, free, informed and express patient consent
  • Exclusion Criteria:
  • Patient with total laryngectomy;
  • History of swallowing disorders prior to critical care admission;
  • History of central nervous system disorders (stroke, Parkinson's disease, etc.)
  • Patient admitted to intensive care following central neurological injury;
  • Patient with spinal cord injury above C5 ;
  • Patient's refusal to participate in the study ;
  • Known pregnancy ;
  • Cognitive impairment incompatible with understanding instructions;
  • Patient under guardianship;
  • Patient with limited care.

About Hopital Forcilles

Hopital Forcilles is a leading clinical research institution dedicated to advancing medical knowledge and improving patient care through innovative clinical trials. With a strong emphasis on patient safety and ethical standards, the hospital collaborates with a diverse network of healthcare professionals and researchers to conduct rigorous studies across various therapeutic areas. By integrating cutting-edge technologies and methodologies, Hopital Forcilles aims to contribute significantly to the development of new treatments and therapies, ultimately enhancing health outcomes for communities both locally and globally.

Locations

Beuvry, , France

Férolles Attilly, , France

Dijon, Bourgogne, France

Lyon, , France

Patients applied

0 patients applied

Trial Officials

DIAZ LOPEZ Carlos, PhD st

Principal Investigator

Hopital Forcilles

LE NEINDRE Aymeric, PhD

Study Director

Hopital Forcilles

Medina i Mirapeix Francesc, PR

Study Director

Universidad de Murcia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported