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NCT Number: NCT05922085

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

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.

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Key information

Conditions

Patient Under Mechanical Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Dijon Bourgogne

Dijon, France

Location status: Recruiting

Location contact

Jose Arturo PINEDA MASEGOSA

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasound

Other

performed within 3 hours prior to extubation

nasofibroscopie

Other

performed within 3 to 24 hours after extubation

Primary outcomes

  1. rate of swallowing disorders

    Time frame: Within 3 to 24 hours of extubation

    assessed by the Penetration-Aspiration Scale (PAS)

Secondary outcomes

  1. 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

  2. Presence (PAS score > 2 for thick liquids) or absence of severe SD, evaluated by FEES

    Time frame: Within 3 to 24 hours following extubation

  3. Relationship between the presence or absence of SD and global muscle strength

    Time frame: Within 3 hours prior to extubation

    Assessed by the MRC scale measurement before extubation

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

    Time frame: Within 3 hours prior to extubation

    Thickness of the right QF and cross-sectional area of the right RF muscle at rest

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

    Time frame: Before extubation

    Evaluated by measuring the Peak Expiratory Flow (PEF) on the ventilator

  6. Concordance between the assessement of parameters measured during the FEES procedure by the otolaryngologist

    Time frame: Within 3 to 24 hours following extubation

    Kappa for qualitative variables

  7. Feasibility of the ultrasound examination

    Time frame: Within 3 hours prior to extubation

    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

  8. Presence (PAS score > 2 for water) or absence of mild SD, evaluated by FEES

    Time frame: Within 3 to 24 hours following extubation

  9. Concordance between the assessement of parameters measured during the FEES procedure by the otolaryngologist

    Time frame: Within 3 to 24 hours following extubation

    ICC for quantitative variables

  10. Concordance between the assessement of parameters measured during the FEES procedure by the intensivist

    Time frame: Within 3 to 24 hours following extubation

    kappa for qualitative variables

  11. Concordance between the assessement of parameters measured during the FEES procedure by the intensivist

    Time frame: Within 3 to 24 hours following extubation

    ICC for quantitative variables

Study contacts

Contact information is provided by the study sponsor or research team.

Jose Arturo PINEDA MASEGOSA

CONTACT

[email protected]

03 80 29 37 51 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: EIDAR

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 28, 2023
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.