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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire Dijon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Major (≥18)

On mechanical ventilation for at least 48 hours

Affiliated to national health insurance

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Ultrasound

    Other intervention

    performed within 3 hours prior to extubation

  • nasofibroscopie

    Other intervention

    performed within 3 to 24 hours after extubation

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: patient under mechanical ventilation for at least 48 hoursExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

rate of swallowing disorders

assessed by the Penetration-Aspiration Scale (PAS)

Time frame
Within 3 to 24 hours of extubation

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

Assessed by the MRC scale measurement before extubation

Time frame
Within 3 hours prior to extubation
4

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

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

Time frame
Within 3 hours prior to extubation

Other outcomes

Sponsors and contacts

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