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

NCT05922085 | Recruiting

• 1 other identifier: PINEDA APPARA 2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patient Under Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• rate of swallowing disorders

  assessed by the Penetration-Aspiration Scale (PAS)

  Within 3 to 24 hours of extubation

Secondary Outcomes (11)

• 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

  Within 3 hours prior to extubation

• Relationship between the presence or absence of SD and muscle mass evaluated by ultrasound

  Within 3 hours prior to extubation

• Relationship between the presence or absence of SD and cough strength before extubation

  Before extubation

Study Arms (1)

patient under mechanical ventilation for at least 48 hours

EXPERIMENTAL

Other: Ultrasound; Other: nasofibroscopie

Interventions

Ultrasound OTHER

performed within 3 hours prior to extubation

patient under mechanical ventilation for at least 48 hours

nasofibroscopie OTHER

performed within 3 to 24 hours after extubation

patient under mechanical ventilation for at least 48 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, France

RECRUITING

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Central Study Contacts

Jose Arturo PINEDA MASEGOSA

CONTACT

03 80 29 37 51; josearturo.pinedamasegosa@chu-dijon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 28, 2023
• Study Start: November 9, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

FR (1)