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

Overview

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.

Interventions

• Other Ultrasound
  performed within 3 hours prior to extubation
• Other nasofibroscopie
  performed within 3 to 24 hours after extubation

Primary outcome measures

• rate of swallowing disorders [Time frame: Within 3 to 24 hours of extubation]

Secondary outcome measures (11)

• Presence (PAS score >2 for at least one of the food textures) or absence of SD evaluated by FEES [Time frame: within 3 to 24 hours following extubation]
• Presence (PAS score > 2 for thick liquids) or absence of severe SD, evaluated by FEES [Time frame: Within 3 to 24 hours following extubation]
• Relationship between the presence or absence of SD and global muscle strength [Time frame: Within 3 hours prior to extubation]
• Relationship between the presence or absence of SD and muscle mass evaluated by ultrasound [Time frame: Within 3 hours prior to extubation]
• Relationship between the presence or absence of SD and cough strength before extubation [Time frame: Before extubation]
• Concordance between the assessement of parameters measured during the FEES procedure by the otolaryngologist [Time frame: Within 3 to 24 hours following extubation]
• Feasibility of the ultrasound examination [Time frame: Within 3 hours prior to extubation]
• Presence (PAS score > 2 for water) or absence of mild SD, evaluated by FEES [Time frame: Within 3 to 24 hours following extubation]
• Concordance between the assessement of parameters measured during the FEES procedure by the otolaryngologist [Time frame: Within 3 to 24 hours following extubation]
• Concordance between the assessement of parameters measured during the FEES procedure by the intensivist [Time frame: Within 3 to 24 hours following extubation]
• Concordance between the assessement of parameters measured during the FEES procedure by the intensivist [Time frame: Within 3 to 24 hours following extubation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

France · 1 center

• Chu Dijon Bourgogne — Dijon

Publications

• Pineda JA, Diaz C, Plasse C, Ruiz de la Fuente JM, Duvillard C, Bozorg-Grayeli A, Pennecot C, Labruyere M, Andreu P, Roudaut JB, Taha A, Morariu-Patrichi A, Jacquier M, Sow AK, Fournel I, Quenot JP. Use of ultrasound for early detection of ICU patients at risk of acquiring swallowing disorders: EIDAR, a prospective diagnostic study protocol. BMJ Open. 2026 Jun 11;16(6):e117547. doi: 10.1136/bmjope PMID 42276803

Identifiers

NCT: NCT05922085 · PINEDA APPARA 2022

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗