Use of Ultrasound for Early Identification of Patients at Risk of Swallowing Disorders Acquired in the ICU (EIDAR)

Swallowing disorders (SD) are particularly common after extubation in the ICU and may be associated with an increased risk of lung disease, increased length of hospital stay, and a higher risk of early reintubation. In contrast, early detection of SDs has been shown to be associated with a decrease in these complications. Thus, there is a need for rapid and reliable assessment of SDs in ICU patients before the withdrawal of mechanical ventilation.

Videofluoroscopy (VFS) and nasofibroscopy (NF) are the gold standard examinations for diagnosing SD. However, these two examinations are not feasible in intubated patients.

In this context, ultrasound appears to be a promising alternative to identify patients at risk of SD after extubation. This examination can be performed at the intubated patient's bedside and can be used evaluate the mobility of the structures involved in swallowing. Many studies have already shown the interest of ultrasound in the evaluation of SD but none has focused on intubated patients under respiratory assistance.

The objective of the present study is to evaluate the value of ultrasound in identifying patients at risk of presenting SD after extubation.

This monocentric study will take place in the Intensive Care Unit (ICU) of the Dijon University Hospital. The duration of participation in this research will be equal to the length of stay in the ICU. During their stay, patients will undergo ultrasound and nasofibroscopy. Information on the characteristics of the ICU stay will be collected at discharge.

Study Overview

• Status: Recruiting
• Conditions: Patient Under Mechanical Ventilation
• Intervention / Treatment: Other: Ultrasound; Other: nasofibroscopie

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jose Arturo PINEDA MASEGOSA; Phone Number: +33 03 80 29 37 51; Email: josearturo.pinedamasegosa@chu-dijon.fr

Study Locations

• France
  • Dijon, France
    • Recruiting
    • CHU Dijon Bourgogne
    • Contact: Jose Arturo PINEDA MASEGOSA; Email: josearturo.pinedamasegosa@chu-dijon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patient:

• Major (≥18)
• On mechanical ventilation for at least 48 hours
• Affiliated to national health insurance

Exclusion Criteria:

Patient:

• Under legal protection (curatorship, guardianship, safeguard of justice)
• Pregnant, parturient or breastfeeding woman
• Refusal to participate by the patient or their proxy (or an immediate family member)
• Cognitive disorders incompatible with the understanding of instructions
• Previously diagnosed swallowing disorders
• With a neurological condition at the origin of the SD (stroke, ALS...)
• Treated for a lesion of the aerodigestive tract (by surgery, radiotherapy or radio-chemotherapy)
• presence of wounds or dressings on the areas to be evaluated that prevent ultrasound measurements
• Patient for whom a decision to limit or stop life support treatments has been taken collegially within the intensive care unit

• With one or more contraindications to performing NF:

  • Anatomical features not compatible with NF: mainly deviation of the nasal septum.
  • Risk of significant otorhinolaryngological bleeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patient under mechanical ventilation for at least 48 hours	Other: Ultrasound; performed within 3 hours prior to extubation; Other: nasofibroscopie; performed within 3 to 24 hours after extubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of swallowing disorders	assessed by the Penetration-Aspiration Scale (PAS)	Within 3 to 24 hours of extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence (PAS score >2 for at least one of the food textures) or absence of SD evaluated by FEES		within 3 to 24 hours following extubation
Presence (PAS score > 2 for thick liquids) or absence of severe SD, evaluated by FEES		Within 3 to 24 hours following extubation
Relationship between the presence or absence of SD and global muscle strength	Assessed by the MRC scale measurement before extubation	Within 3 hours prior to extubation
Relationship between the presence or absence of SD and muscle mass evaluated by ultrasound	Thickness of the right QF and cross-sectional area of the right RF muscle at rest	Within 3 hours prior to extubation
Relationship between the presence or absence of SD and cough strength before extubation	Evaluated by measuring the Peak Expiratory Flow (PEF) on the ventilator	Before extubation
Concordance between the assessement of parameters measured during the FEES procedure by the otolaryngologist	Kappa for qualitative variables	Within 3 to 24 hours following extubation
Feasibility of the ultrasound examination	Proportion of ultrasounds performed (number of ultrasounds performed / number of eligible extubated patients) Identification of the reasons for not performing the ultrasound (e.g., physiotherapist unavailability, patient refusal) Proportion of uninterpretable ultrasounds (number of uninterpretable ultrasounds/number of ultrasounds performed) Identification of the reasons for uninterpretability of the ultrasound Mean time taken to perform the ultrasonographic assessment	Within 3 hours prior to extubation
Presence (PAS score > 2 for water) or absence of mild SD, evaluated by FEES		Within 3 to 24 hours following extubation
Concordance between the assessement of parameters measured during the FEES procedure by the otolaryngologist	ICC for quantitative variables	Within 3 to 24 hours following extubation
Concordance between the assessement of parameters measured during the FEES procedure by the intensivist	kappa for qualitative variables	Within 3 to 24 hours following extubation
Concordance between the assessement of parameters measured during the FEES procedure by the intensivist	ICC for quantitative variables	Within 3 to 24 hours following extubation

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 19, 2023
• First Submitted That Met QC Criteria: June 19, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders; Physical Phenomena; Radiation; Radiation, Nonionizing; Ultrasonic Waves; Sound; High-Energy Shock Waves
• Other Study ID Numbers: PINEDA APPARA 2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No