New ultrasound method for diagnosing swallowing disorders in ICU patients with tracheostomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on patients in the intensive care unit (ICU) who have undergone tracheostomy and are at risk for swallowing disorders (SD). It aims to develop a new ultrasound scoring system to assess swallowing function, which could provide a non-invasive and precise alternative to traditional diagnostic methods like videofluoroscopy and FEES. The study will involve systematic bedside screening and ultrasound imaging to evaluate the anatomical and functional aspects of swallowing, ultimately aiming to improve targeted rehabilitation strategies for affected patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Groupement Hospitalier Nord Dauphiné, CH Bourgoin-Jallieu
  Lyon, Lyon, France Recruiting
• Hôpital Forcilles
  Férolles-Attilly, France Recruiting
• Ch de Béthune
  Beuvry, Beuvry, France Not yet recruiting
• CHU Dijon Bourgogne
  Dijon, Bourgogne-Franche-Comté, France Not yet recruiting

Study contacts

• Principal investigator: DIAZ LOPEZ Carlos, PhD st — Hopital Forcilles
• Study coordinator: LE NEINDRE Aymeric, PhD
• Email: aleneindre@cognacq-jay.fr
• Phone: +33160646093

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.