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

N/ARecruitingNCT05922085

Centre Hospitalier Universitaire Dijon100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

100

Conditions

Patient Under Mechanical Ventilation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

rate of swallowing disorders

assessed by the Penetration-Aspiration Scale (PAS)

Time frame: Within 3 to 24 hours of extubation

Secondary Outcomes

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

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

Time frame: Within 3 to 24 hours following extubation

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

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

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

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

Time frame: Before extubation

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

Kappa for qualitative variables

Time frame: Within 3 to 24 hours following extubation

Feasibility of the ultrasound examination

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

Time frame: Within 3 hours prior to extubation

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

Time frame: Within 3 to 24 hours following extubation

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

ICC for quantitative variables

Time frame: Within 3 to 24 hours following extubation

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

kappa for qualitative variables

Time frame: Within 3 to 24 hours following extubation

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

ICC for quantitative variables

Time frame: Within 3 to 24 hours following extubation

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts