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

Construction and Evaluation of a New Ultrasound Score for the Diagnosis of Swallowing Disorders in Difficult-to-wean Tracheostomised Patients

This study is testing a new ultrasound method to see if it can help doctors better diagnose swallowing problems in ICU patients with tracheostomy.

Quick facts

• Study type: Observational
• Enrollment: 114 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hopital Forcilles (Academic / other)
• Locations: 4 sites (Beuvry, Beuvry and 3 other locations)
• Trial ID: NCT06630013 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include ICU patients who are tracheostomised for difficult-to-wean reasons and require physiotherapy assessment.

Not a fit: Patients with total laryngectomy or pre-existing swallowing disorders prior to ICU admission may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate and less invasive assessments of swallowing disorders, improving patient outcomes and rehabilitation strategies.

How similar studies have performed: While ultrasound imaging for swallowing assessment is gaining interest, this specific approach in ICU patients is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Beuvry, Beuvry and 3 other locations

• Ch de Béthune — Beuvry, Beuvry, France (Not_yet_recruiting)
• CHU Dijon Bourgogne — Dijon, Bourgogne-Franche-Comté, France (Not_yet_recruiting)
• Groupement Hospitalier Nord Dauphiné, CH Bourgoin-Jallieu — Lyon, Lyon, France (Recruiting)
• Hôpital Forcilles — Férolles-Attilly, France (Recruiting)

Study contacts

• Principal investigator: DIAZ LOPEZ Carlos, PhD st — Hopital Forcilles
• Study coordinator: LE NEINDRE Aymeric, PhD

Conditions Deglutition Disorders