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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHopital Forcilles

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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 ;

Disqualifiers

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;

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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

Time frame
The day of FEES evaluation during two hour time-frame

Secondary outcomes

1

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

Ultrasound evaluation of tongue thickness and movement at rest et during swallow

Time frame
The day of FEES evaluation during two hour time-frame
2

Accuracy and reliability of hyoid movement on swallowing disorder diagnosis

Hyoid bone displacement will be recorded during swallowing and measured by assessing the distance between the hyoid and mandible at rest and at maximum approach.

Time frame
The day of FEES evaluation during two hour time-frame
3

Accuracy and reliability of suprahyoid muscles characteristics on swallowing disorder diagnosis

Linear transducer will be used to obtain a coronal plane of suprahyoid muscles. Suprahyoid muscles cross sectional area will be recorded and measured in square centimeters.

Time frame
The day of FEES evaluation during two hour time-frame

Other outcomes

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