EICHORCondition: Deglutition Disorders · Sponsor: Hopital Forcilles
Interested? Contact the study team ↓
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
Swallowing Disorders (SD) is commonly observed in intensive care unit (ICU) patients. Disruption to the upper airway by way of a tracheostomy may lead to physiological and/or biomechanical changes to the swallow, thereby increasing dysphagia risk. SD is independently associated with adverse outcomes including respiratory complications, nutritional compromise, and even death. Experts recommend a systematic bedside screening. Most algorithms include the water swallow test followed by expert comprehensive swallowing assessments of screening positive patients. However, the clinical examination lacks precision. Complementary examinations, such as videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing (FEES), are irradiating or invasive, consume numerous resources and are difficult to access. No current consensus exists on how to best approach to evaluate ICU patients at risk. In this context, US imaging has garnered increased interest for assessing swallowing disorders. Recognised for its non-invasive nature and its ability to overcome conventional constraints, this approach, enabling both qualitative and quantitative analysis of multiple structures, would enhance the precision in targeting structures for rehabilitation. The researchers intend to create an ultrasound diagnostic model for difficult-to-wean trahceostomised patients. Additionally, they aim to evaluate the reliability and accuracy of this model. During an nineteen-months period, we will enrolled one …
This description comes directly from the study's public registry record.
LE NEINDRE Aymeric, PhD · +33160646093 · aleneindre@cognacq-jay.fr
DIAZ LOPEZ Carlos, PhD st · +33160646130 · cdiaz.physio@gmail.com
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
Inclusion Criteria: * Patients admitted to ICU and tracheostomised for difficult-to-wean reasons ; * Patients with a medical indication for nasofibroscopy ; * Medical prescription for physiotherapy assessment ; * Ultrasound operator available ; * Patient at least 18 years old at the time of inclusion; * Oral, free, informed and express patient consent Exclusion Criteria: * Patient with total laryngectomy; * History of swallowing disorders prior to critical care admission; * History of central nervous system disorders (stroke, Parkinson's disease, etc.) * Patient admitted to intensive care following central neurological injury; * Patient with spinal cord injury above C5 ; * Patient's refusal to participate in the study ; * Known pregnancy ; * Cognitive impairment incompatible with understanding instructions; * Patient under guardianship; * Patient with limited care.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Ch de Béthune | Beuvry, Beuvry, France | Not Yet Recruiting |
| CHU Dijon Bourgogne | Dijon, Bourgogne-Franche-Comté, France | Not Yet Recruiting |
| Groupement Hospitalier Nord Dauphiné, CH Bourgoin-Jallieu | Lyon, Lyon, France | Recruiting |
| Hôpital Forcilles | Férolles-Attilly, France | Recruiting |
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice. By subscribing you agree to our Terms of Use and Privacy Policy.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06630013