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

NCT06630013 | Recruiting DMC

• 1 other identifier: 2024-A00285-42
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 4

Brief Summary

Swallowing Disorders (SD) is commonly observed in intensive care unit (ICU) patients. Disruption to the upper airway by way of a tracheostomy may lead to physiological and/or biomechanical changes to the swallow, thereby increasing dysphagia risk. SD is independently associated with adverse outcomes including respiratory complications, nutritional compromise, and even death. Experts recommend a systematic bedside screening. Most algorithms include the water swallow test followed by expert comprehensive swallowing assessments of screening positive patients. However, the clinical examination lacks precision. Complementary examinations, such as videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing (FEES), are irradiating or invasive, consume numerous resources and are difficult to access. No current consensus exists on how to best approach to evaluate ICU patients at risk. In this context, US imaging has garnered increased interest for assessing swallowing disorders. Recognised for its non-invasive nature and its ability to overcome conventional constraints, this approach, enabling both qualitative and quantitative analysis of multiple structures, would enhance the precision in targeting structures for rehabilitation. The researchers intend to create an ultrasound diagnostic model for difficult-to-wean trahceostomised patients. Additionally, they aim to evaluate the reliability and accuracy of this model. During an nineteen-months period, we will enrolled one hundred and nineteen difficult-to-wean tracheostomised patients at Forcilles's Hospital, Universitary Hospital of Dijon, Béthune Hospital and Bourgon Jallieu Hospital. All patients will have a FEES evaluation. The ultrasonographer will be blinded to the patient's status and prior clinical or imaging assessments. Ultrasound assessment will focus on evaluating the movements or morphology of structures such as the tongue, laryngeal movement, or suprahyoid muscles. A global ultrasound diagnostic model will be developed after selecting variables in logistic multivariable regression. Its sensitivity and specificity and prediction value will be estimated. The constructed model will be transformed in an easy-to-use scoring system. The study anticipates establishing an association between ultrasound markers and swallowing disorders, aiming to enhance early detection for tailored management strategies, providing a non-invasive alternative to videofluoroscopy or FEES.

Conditions

Deglutition Disorders

Outcome Measures

Primary Outcomes (1)

• Swallowing disorders prediction model development

  Selection of the most contributive ultrasound measures in the swallowing disorders diagnostic predictive model. The morphology and/or movement of the tongue, hyoid bone and suprahyoid muscles measured by ultrasound on swallowing disorder diagnosis

  The day of FEES evaluation during two hour time-frame

Secondary Outcomes (3)

• Accuracy and reliability of tongue morphologic and kinematics characteristics on swallowing disorder diagnosis

  The day of FEES evaluation during two hour time-frame

• Accuracy and reliability of hyoid movement on swallowing disorder diagnosis

  The day of FEES evaluation during two hour time-frame

• Accuracy and reliability of suprahyoid muscles characteristics on swallowing disorder diagnosis

  The day of FEES evaluation during two hour time-frame

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll one hundred and nineteen difficult-to-wean tracheostomised patients at Critical Care services of Forcilles's Hospital, Universitary Hospital of Dijon, Béthune Hospital and Bourgon Jallieu Hospital.

You may qualify if:

• 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 ;
• Oral, free, informed and express patient consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital Forcilles: lead

Study Sites (4)

Ch de Béthune

Beuvry, Beuvry, 62660, France

NOT YET RECRUITING

CHU Dijon Bourgogne

Dijon, Bourgogne-Franche-Comté, 21231, France

NOT YET RECRUITING

Groupement Hospitalier Nord Dauphiné, CH Bourgoin-Jallieu

Lyon, Lyon, 38302, France

RECRUITING

Hôpital Forcilles

Férolles-Attilly, 77150, France

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• DIAZ LOPEZ Carlos, PhD st

  Hopital Forcilles

  PRINCIPAL INVESTIGATOR

• LE NEINDRE Aymeric, PhD

  Hopital Forcilles

  STUDY DIRECTOR

• Medina i Mirapeix Francesc, PR

  Universidad de Murcia

  STUDY DIRECTOR

Central Study Contacts

LE NEINDRE Aymeric, PhD

CONTACT

+33160646093; aleneindre@cognacq-jay.fr

DIAZ LOPEZ Carlos, PhD st

CONTACT

+33160646130; cdiaz.physio@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start: July 9, 2024
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

FR (4)