Diagnostic Accuracy of Aerodigestive Ultrasound for Predicting Swallowing Disorders

NCT04800783 | Completed DMC

• 1 other identifier: 2020-A02942-37
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Swallowing disorders management requires an accurate recognition of implicated anatomical structures and pathways. The usual clinical assessment of swallowing disorders lacks reliability and accuracy. The gold standard remains the videofluoroscopy. However, this imaging technique lacks reliability and standardisation. Moreover, videofluoroscopy is not easily available, time and material consuming and exposes patients to ionisation. Ultrasound imaging, which can be performed at the patient's bedside, is a non-invasive tool. It allows the evaluation of the main structures involved in all the swallowing pathways and may be a promising tool to assess the swallowing disorders. An ultrasound predictive model has never been developed to diagnose swallowing disorders. The investigators aim to develop an ultrasound predictive model to diagnose swallowing disorders, and assess its reliability and accuracy. One hundred outpatients at risk of swallowing disorders (neck cancer, neurological diseases, previous ICU stay) will be enrolled in the Dysphagia Diagnostic Unit at the Forcilles' Hospital, during a 2-year period. All patients will undergo a clinical examination by a speech-language therapist, and a videofluoroscopy imaging in order to diagnose swallowing disorders. Then, an ultrasound examination will be performed by the ultrasonographer. The ultrasonographer will be blinded from the patient's status and previous clinical and imaging assessments. Severity of the swallowing disorder will be assessed by the Dysphagia Outcome and Severity Scale. The tongue kinetics and thickness, the laryngeal movement and the suprahyoid muscles thickness and echogenicity will be assessed by ultrasonography. Inter- and intra-reliability of ultrasound examination will be calculated. The threshold of each ultrasound measurement allowing the swallowing disorders will be estimated using the ROC curve analysis. Sensitivity and specificity of each ultrasound measurement will be estimated. A global ultrasound predictive model will be developed after selecting variables in logistic multivariable regression. Diagnostic accuracy of the global predictive model will also be assessed. The investigators hope a high reliability and accuracy of the ultrasound predictive model in the swallowing disorders diagnostic. As ultrasonography is easy-to-perform, rapidly available, non-invasive and inexpensive, it may be a valuable alternative to videofluoroscopy in swallowing disorder diagnostic.

Conditions

Deglutition Disorders

Keywords

Swallowing disorders; Ultrasonography; Outpatients; Laryngeal; Tongue; Validation study

Outcome Measures

Primary Outcomes (1)

• Swallowing ultrasound predictive model development

  Selection of the most contributive ultrasound measures in the swallowing disorders diagnostic predictive model.

  Through study completion, an average of 2 years

Secondary Outcomes (5)

• Accuracy and reliability of ultrasound measure of hyoid bone movement

  Through study completion, an average of 2 years

• Accuracy and reliability of ultrasound measure of the tongue kinetics

  Through study completion, an average of 2 years

• Accuracy and reliability of ultrasound measure of the digastric muscles

  Through study completion, an average of 2 years

• Accuracy and reliability of ultrasound assessment of the geniohyoid muscle

  Through study completion, an average of 2 years

• Inter and intra-operator reliability assessment of the swallowing ultrasound assessment

  Through tweenty first inclusion completion, an average of 15 weeks

Study Arms (1)

Swallowing disorders cohort

OTHER

All included patients will undergo an ultrasound assessment of the oral and laryngeal structures involved in the swallowing process.

Diagnostic Test: Swallowing ultrasound

Interventions

Swallowing ultrasound DIAGNOSTIC_TEST

Ultrasound assessment of the tongue movement and thickening, the geniohyoid and suprahyoid muscles echogenicity, thickness and thickening, the hyoid bone elevation, and the number of swallowing trial.

Swallowing disorders cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients refered to swallowing assessment at the Forcilles' hospital;
• Medical indication to perform a videofluoroscopy;
• Ultrasonographer available;
• Age \> 18 years old;
• Membership of a social insurance sheme;
• Patient provides consent.

You may not qualify if:

• Previous laryngectomy surgery;
• Refusal to participate in the study;
• Known pregnancy;
• Person subject to judicial health protection;
• Cognitive disorder incompatible with the understanding of instructions;
• Patient under guardianship or curatorship.

Sponsors & Collaborators

• Hopital Forcilles: lead

Study Sites (1)

Hôpital Forcilles

Férolles-Attilly, Île-de-France Region, 77150, France

Location

MeSH Terms

Conditions

Deglutition Disorders; Laryngeal Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Carlos Diaz Lopez, PT

  Hôpital Forcilles-Fondation Cognacq-Jay

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective interventional study including consecutive patients

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 16, 2021
• Study Start: March 5, 2021
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Data requesters must provide supporting documentation (e.g: research proposals) to the principal investigator. Request will be reviewed by the research committee of the sponsor.

Locations

FR (1)