[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510103":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":16,"studyPopulation":16,"armGroups":52,"interventions":59,"overallOfficials":16,"centralContacts":68,"locations":75,"responsibleParty":90,"collaborators":16,"id":92,"slug":16,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":16,"enrollmentInfo":100,"targetDuration":16,"studyType":103,"phases":104,"briefSummary":105,"conditions":106,"keywords":16,"overallStatus":78,"whyStopped":16,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Centre Hospitalier Universitaire Dijon","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"rate of swallowing disorders","assessed by the Penetration-Aspiration Scale (PAS)","Within 3 to 24 hours of extubation",[14,18,21,25,28,32,35,38,40,42,45],{"measure":15,"description":16,"timeFrame":17},"Presence (PAS score >2 for at least one of the food textures) or absence of SD evaluated by FEES",null,"within 3 to 24 hours following extubation",{"measure":19,"description":16,"timeFrame":20},"Presence (PAS score > 2 for thick liquids) or absence of severe SD, evaluated by FEES","Within 3 to 24 hours following extubation",{"measure":22,"description":23,"timeFrame":24},"Relationship between the presence or absence of SD and global muscle strength","Assessed by the MRC scale measurement before extubation","Within 3 hours prior to extubation",{"measure":26,"description":27,"timeFrame":24},"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",{"measure":29,"description":30,"timeFrame":31},"Relationship between the presence or absence of SD and cough strength before extubation","Evaluated by measuring the Peak Expiratory Flow (PEF) on the ventilator","Before extubation",{"measure":33,"description":34,"timeFrame":20},"Concordance between the assessement of parameters measured during the FEES procedure by the otolaryngologist","Kappa for qualitative variables",{"measure":36,"description":37,"timeFrame":24},"Feasibility of the ultrasound examination","Proportion of ultrasounds performed (number of ultrasounds performed \u002F 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\u002Fnumber of ultrasounds performed) Identification of the reasons for uninterpretability of the ultrasound Mean time taken to perform the ultrasonographic assessment",{"measure":39,"description":16,"timeFrame":20},"Presence (PAS score > 2 for water) or absence of mild SD, evaluated by FEES",{"measure":33,"description":41,"timeFrame":20},"ICC for quantitative variables",{"measure":43,"description":44,"timeFrame":20},"Concordance between the assessement of parameters measured during the FEES procedure by the intensivist","kappa for qualitative variables",{"measure":43,"description":41,"timeFrame":20},{"allocation":47,"interventionModel":48,"interventionModelDescription":16,"primaryPurpose":49,"observationalModel":16,"timePerspective":16,"maskingInfo":50},"NA","SINGLE_GROUP","PREVENTION",{"masking":51,"maskingDescription":16,"whoMasked":16},"NONE",[53],{"label":54,"type":55,"description":16,"interventionNames":56},"patient under mechanical ventilation for at least 48 hours","EXPERIMENTAL",[57,58],"Other: Ultrasound","Other: nasofibroscopie",[60,64],{"type":6,"name":61,"description":62,"armGroupLabels":63,"otherNames":16},"Ultrasound","performed within 3 hours prior to extubation",[54],{"type":6,"name":65,"description":66,"armGroupLabels":67,"otherNames":16},"nasofibroscopie","performed within 3 to 24 hours after extubation",[54],[69],{"name":70,"role":71,"phone":72,"phoneExt":73,"email":74},"Jose Arturo PINEDA MASEGOSA","CONTACT","03 80 29 37 51","+33","josearturo.pinedamasegosa@chu-dijon.fr",[76],{"facility":77,"status":78,"city":79,"state":16,"zip":16,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Chu Dijon Bourgogne","RECRUITING","Dijon","France","FR",{"type":83,"coordinates":84},"Point",[85,86],5.01391,47.31344,{"lat":86,"lon":85},[89],{"name":70,"role":71,"phone":16,"phoneExt":16,"email":74},{"type":91,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100510103",false,"NCT05922085","Use of Ultrasound for Early Identification of Patients at Risk of Swallowing Disorders Acquired in the ICU","EIDAR","Inclusion Criteria:\n\nPatient:\n\n* Major (≥18)\n* On mechanical ventilation for at least 48 hours\n* Affiliated to national health insurance\n\nExclusion Criteria:\n\nPatient:\n\n* Under legal protection (curatorship, guardianship, safeguard of justice)\n* Pregnant, parturient or breastfeeding woman\n* Refusal to participate by the patient or their proxy (or an immediate family member)\n* Cognitive disorders incompatible with the understanding of instructions\n* Previously diagnosed swallowing disorders\n* With a neurological condition at the origin of the SD (stroke, ALS...)\n* Treated for a lesion of the aerodigestive tract (by surgery, radiotherapy or radio-chemotherapy)\n* presence of wounds or dressings on the areas to be evaluated that prevent ultrasound measurements\n* Patient for whom a decision to limit or stop life support treatments has been taken collegially within the intensive care unit\n* With one or more contraindications to performing NF:\n\n  * Anatomical features not compatible with NF: mainly deviation of the nasal septum.\n  * Risk of significant otorhinolaryngological bleeding","ALL","18 Years",{"count":101,"type":102},100,"ESTIMATED","INTERVENTIONAL",[47],"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.\n\nVideofluoroscopy (VFS) and nasofibroscopy (NF) are the gold standard examinations for diagnosing SD. However, these two examinations are not feasible in intubated patients.\n\nIn 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.\n\nThe objective of the present study is to evaluate the value of ultrasound in identifying patients at risk of presenting SD after extubation.\n\nThis 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.",[107],"Patient Under Mechanical Ventilation","2026-05-06",{"date":110,"type":111},"2026-05-12","ACTUAL",{"date":113,"type":111},"2023-11-09",{"date":115,"type":102},"2027-06",{"name":5,"class":6},1]