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

NCT ID: NCT05922085

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-09
• Study Completion Date: 2027-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

patient under mechanical ventilation for at least 48 hours

Group Type: EXPERIMENTAL

Ultrasound

Intervention Type: OTHER

performed within 3 hours prior to extubation

nasofibroscopie

Intervention Type: OTHER

performed within 24 to 36 hours after extubation

Interventions

Ultrasound

performed within 3 hours prior to extubation

Intervention Type: OTHER

nasofibroscopie

performed within 24 to 36 hours after extubation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patient:

• Major
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Dijon Bourgogne

Dijon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jose Arturo PINEDA MASEGOSA

Role: CONTACT

josearturo.pinedamasegosa@chu-dijon.fr

Facility Contacts

Jose Arturo PINEDA MASEGOSA

Role: primary

josearturo.pinedamasegosa@chu-dijon.fr

Other Identifiers

PINEDA APPARA 2022

Identifier Type: -

Identifier Source: org_study_id