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Diagnostic Accuracy of Aerodigestive Ultrasound for Predicting Swallowing Disorders

NCT04800783 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2023-10-11

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Swallowing ultrasound

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.

Sponsors & Collaborators

  • Hopital Forcilles

    lead OTHER

Principal Investigators

  • Carlos Diaz Lopez, PT · Hôpital Forcilles-Fondation Cognacq-Jay

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-05
Primary Completion
2023-04-04
Completion
2023-04-04

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04800783 on ClinicalTrials.gov