NCT05922085 Use of Ultrasound for Early Identification of Patients at Risk of Swallowing Disorders Acquired in the ICU
| NCT ID | NCT05922085 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire Dijon |
| Condition | Patient Under Mechanical Ventilation |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-11-09 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-11-09 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05922085 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Patient Under Mechanical Ventilation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05922085 currently recruiting?
Yes, NCT05922085 is actively recruiting participants. Contact the research team at josearturo.pinedamasegosa@chu-dijon.fr for enrollment information.
Where is the NCT05922085 trial being conducted?
This trial is being conducted at Dijon, France.
Who is sponsoring the NCT05922085 clinical trial?
NCT05922085 is sponsored by Centre Hospitalier Universitaire Dijon. The trial plans to enroll 100 participants.