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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• rate of swallowing disorders [Срок оценки: Within 3 to 24 hours of extubation]

Вторичные конечные точки (11)

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

Критерии участия

Критерии включения

Patient:

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• Chu Dijon Bourgogne — Dijon

Публикации

• 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

Идентификаторы

NCT: NCT05922085 · PINEDA APPARA 2022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗