[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518638":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":41,"studyPopulation":42,"armGroups":43,"interventions":53,"overallOfficials":37,"centralContacts":59,"locations":69,"responsibleParty":100,"collaborators":37,"id":102,"slug":37,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":110,"maxAge":37,"enrollmentInfo":111,"targetDuration":37,"studyType":114,"phases":37,"briefSummary":115,"conditions":116,"keywords":37,"overallStatus":72,"whyStopped":37,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Hopital Forcilles","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Prevalence of Tapia's syndrome","The main objective of this study is to determine the prevalence of Tapia syndrome in patients admitted to the weaning unit after prolonged orotracheal intubation in intensive care. The orotracheal intubation is defined as an intubation longer than 48 hours.","through study completion, an average of 2 years",[14,17,20,24,28,31,34],{"measure":15,"description":16,"timeFrame":12},"Lingual involvment","yes\u002Fno\u002Fmeasure of lingual deviation in mm and width of each half of tongue in mm with MEEI software)",{"measure":18,"description":19,"timeFrame":12},"Soft palate involvement","yes\u002Fno",{"measure":21,"description":22,"timeFrame":23},"Determining the factors associated with Tapia syndrome","Determining the factors associated with Tapia syndrome : number of prone sessions, duration of intubation (day), duration of mechanical ventilation (day), tracheostomy duration (day), Cormack-Lehane's class, time to tracheostomy cannula removal (day), the time to resume oral feeding (day), number of days in the ICU, number of days in weaning unit, the number of pulmonary infections during the intubation and tracheostomy period, sex, the size of the intubation probe in mm","The day of inclusion",{"measure":25,"description":26,"timeFrame":27},"Dysphonia","GRBAS, maximum time of phonation (s), base frequency (Hz), jitter (%), harmonic noise ratio (dB), vocal range (dB), vocal tessitura (dB)","After initial swallowing test, maximum 1 week",{"measure":29,"description":30,"timeFrame":12},"Dysphagia","Functional oral intake scale (Level 1-Nothing by mouth to Level 7-Total oral diet with no restrictions)",{"measure":32,"description":33,"timeFrame":27},"Nasofibroscopy","immobility of one or both vocal cords on nasofibroscopy",{"measure":35,"description":36,"timeFrame":27},"Ultrasound","hyoid-mandibular distance at rest and during swallowing in cm), tongue thickness at rest in cm, geniohyoidien thickness in mm and area in mm2, echogenicity (Heckmatt score), vallecula stasis (yes\u002Fno), stasis in the piriform sinuses (yes\u002Fno)",null,{"allocation":37,"interventionModel":37,"interventionModelDescription":37,"primaryPurpose":37,"observationalModel":39,"timePerspective":40,"maskingInfo":37},"COHORT","PROSPECTIVE","The main aim of this study was to determine the prevalence of Tapia syndrome in patients admitted to weaning unit after prolonged (\\>48h) orotracheal intubation in the ICU.\n\nThe secondary objectives are to:\n\n* Describe the clinical semiology of Tapia syndrome : lingual involvement, soft palate involvement, impairment of phonation and swallowing ;\n* Describe the paraclinical features of Tapia syndrome: recurrent involvement, laryngeal and lingual involvement;\n* Identify factors associated with Tapia's syndrome","Patients who were intubated during more than 48 hours in ICU then tracheostomized and hospitalized in weaning unit.",[44,49],{"label":45,"type":37,"description":46,"interventionNames":47},"\"Non Tapia group\"","Patients without Tapia's syndrome",[48],"Diagnostic Test: Diagnosis of Tapia's Syndrome",{"label":50,"type":37,"description":51,"interventionNames":52},"\"Tapia group\"","Patient with Tapia's syndrome",[48],[54],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":37},"DIAGNOSTIC_TEST","Diagnosis of Tapia's Syndrome","The diagnostic includes :\n\n* Lingual clinical examination\n* Nasofibroscopy\n* Ultrasonography",[45,50],[60,65],{"name":61,"role":62,"phone":63,"phoneExt":37,"email":64},"Estelle ROBIN, SLT","CONTACT","01.60.64.62.41","erobin@cognacq-jay.fr",{"name":66,"role":62,"phone":67,"phoneExt":37,"email":68},"Aymeric LE NEINDRE, Dr","01.60.64.60.93","aleneindre@cognacq-jay.fr",[70],{"facility":71,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Hôpital Forcilles","RECRUITING","Férolles-Attilly","Seine-et-Marne","77150","France","FR",{"type":79,"coordinates":80},"Point",[81,82],2.63088,48.73184,{"lat":82,"lon":81},[85,88,91,94,96,98],{"name":61,"role":62,"phone":86,"phoneExt":37,"email":87},"+33160646241","erobin@cogancq-jay.fr",{"name":89,"role":62,"phone":90,"phoneExt":37,"email":68},"Aymeric LE NEINDRE, PhD","+33160646093",{"name":92,"role":93,"phone":37,"phoneExt":37,"email":37},"Agnès PEREIRA, SLT","PRINCIPAL_INVESTIGATOR",{"name":95,"role":93,"phone":37,"phoneExt":37,"email":37},"Magalie BOUCHOUX, SLT",{"name":97,"role":93,"phone":37,"phoneExt":37,"email":37},"Jean-Baptiste PERETOUT, MD",{"name":99,"role":93,"phone":37,"phoneExt":37,"email":37},"Gérald CHOUKROUN, MD",{"type":101,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100518638",false,"NCT06033144","Prevalence of Tapia's Syndrome in Weaning Unit","Prevalence of Tapia's Syndrome in Weaning Unit and Associated Factors After Orotracheal Intubation in the ICU","PRESTIO","Inclusion Criteria:\n\n* Hospitalized in weaning unit\n* Duration of orotracheal intubation in the ICU greater than 48 hours;\n* Glasgow score greater than or equal to 13 ;\n* Patient at least 18 years of age at the time of inclusion;\n* Affiliation with a social security system or beneficiary of such a system ;\n* Oral, free, informed and express consent of the patient.\n\nExclusion Criteria:\n\n* Known history of ENT or neurological pathologies (stroke, head trauma, neurodegenerative disease, brain tumor, ENT cancer);\n* Known tumors in the vicinity of the X-nerve pathway;\n* Ortner's syndrome (left recurrent nerve compression through the left atrium in mitral stenosis);\n* Left lung cancer with subaortic lesion;\n* History of cervical adenopathy compressing the X nerve;\n* Presence of a cervical or cerebral abscess;\n* 24-hour ventilated patient;\n* Refusal of the patient or designated trusted person to participate in the study;\n* Person subject to a safeguard of justice measure ;","ALL","18 Years",{"count":112,"type":113},247,"ESTIMATED","OBSERVATIONAL","Tapia syndrome is a rare and poorly understood pathology. It is defined by a concomitant attack of the recurrent (branch of X) and hypoglossal (XII) nerves of peripheral or central origin. It is characterized by the paralysis of a vocal cord and the ipsilateral half of tongue. This damage is most often unilateral but it can also be bilateral. It results in dysphonia and swallowing disorders.\n\nTapia syndrome is a rare and poorly understood pathology. To date, less than 100 cases have been described in the literature. Previous works are mainly case reports and literature reviews. No prevalence study has been performed to date. Furthermore, disagreements persist regarding the semiology. Indeed, the involvement of the soft palate is not always described.",[117],"Tapia's Syndrome","2025-09-09",{"date":120,"type":121},"2025-09-15","ACTUAL",{"date":123,"type":121},"2023-04-07",{"date":125,"type":113},"2027-04-07",{"name":5,"class":6},1]