Using ultrasound to identify ICU patients at risk of swallowing disorders
Use of Ultrasound for Early Identification of Patients at Risk of Swallowing Disorders Acquired in the ICU
This study is testing if using ultrasound can help doctors quickly find out which ICU patients on ventilators are at risk for swallowing problems before they are taken off the machine.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Dijon) |
| Trial ID | NCT05922085 on ClinicalTrials.gov |
What this trial studies
This study aims to utilize ultrasound technology for the early detection of swallowing disorders in patients who have been on mechanical ventilation for at least 48 hours in the ICU. Swallowing disorders are common after extubation and can lead to serious complications, including lung disease and prolonged hospital stays. By assessing the mobility of swallowing structures at the bedside, the study seeks to provide a rapid and reliable method for identifying patients at risk before they are extubated. This approach could potentially replace more invasive diagnostic methods that are not feasible for intubated patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients who have been on mechanical ventilation for at least 48 hours.
Not a fit: Patients with pre-existing swallowing disorders or neurological conditions that could affect swallowing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier identification and management of swallowing disorders, reducing complications and improving patient outcomes in the ICU.
How similar studies have performed: While ultrasound has shown promise in evaluating swallowing disorders, this specific application in intubated ICU patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dijon
- Chu Dijon Bourgogne — Dijon, France (Recruiting)
Study contacts
- Study coordinator: Jose Arturo PINEDA MASEGOSA
- Email: josearturo.pinedamasegosa@chu-dijon.fr
- Phone: 03 80 29 37 51
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.