[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530378":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":36,"centralContacts":40,"locations":44,"responsibleParty":46,"collaborators":44,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":44,"enrollmentInfo":57,"targetDuration":44,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":70,"whyStopped":44,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":44},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"plated balloon tracheostomy cannulas","EXPERIMENTAL","4 interfaces are tested: cap, ventilator, filter and phonation valve",[13,14],"Device: low pressure tracheostomy cannulas","Device: plated balloon tracheostomy cannulas",{"label":16,"type":17,"description":11,"interventionNames":18},"low pressure balloon tracheotomy cannulas","ACTIVE_COMPARATOR",[13,14],[20,29],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","low pressure tracheostomy cannulas","The tracheostomy tube is changed according to the randomization sequence, a filter is connected for 5 minutes; then baseline data will be assessed. The tracheostomy tube is then connected to the four interfaces for 30 minutes each. Parameters is measured after each 30-minute period. The cuff of the tracheostomy tube will be deflated using a syringe when the interface is a filter, phonation valve, or cap. In contrast, the cuff will be inflated when the interface is the ventilator.\n\nThe cuff is inflated with a manometer for the low-pressure balloon tracheostomy tube and with the minimum and sufficient amount of injectable water for the plated balloon tracheostomy tube to avoid overpressure",[16,9],[26,27,28],"non fenestrated TRACOE® twist","TRACOE tracheostomy tubes with low-pressure cuff","low wall thickness and a good fit of the inner cannula in the outer cannula",{"type":21,"name":9,"description":23,"armGroupLabels":30,"otherNames":31},[16,9],[32,33,34,35],"Bivona® TTS™ Tracheostomy Tubes","silicone tube TTS™ cuff","tubes are coated with a SuperSlick®","soft, confort and flexible tube",[37],{"name":38,"affiliation":5,"role":39},"Julie Delemazure","PRINCIPAL_INVESTIGATOR",[41],{"name":38,"role":42,"phone":43,"phoneExt":44,"email":45},"CONTACT","+33 1 84 82 75 72",null,"julie.delemazure@aphp.fr",{"type":47,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100530378","impact-of-the-nature-and-interface-of-the-tracheostomy-cannula-on-dyspnea-in-patients-weaning-from-artificial-ventilation-in-weaning-unit-100530378",false,"NCT06185998","Impact of the Nature and Interface of the Tracheostomy Cannula on Dyspnea in Patients Weaning From Artificial Ventilation in Weaning Unit","DYSTRACH","Inclusion Criteria:\n\n* Patient aged 18 years or older\n* Patient admitted to SRPR with respiratory and hemodynamic stability\n* Patient with a tracheostomy tube\n* Deflated balloon for more than 6 hours per day\n* Able to tolerate at least 1 hour on cap and phonation valve (deflated balloon)\n* Able to remain at least 3 consecutive hours without ventilation\n* Patient with at least one non-zero dyspnea numerical rating scale (NRS) score in the 72 hours preceding inclusion\n* Able to respond to self-administered questionnaires on dyspnea\n* Patients affiliated with a social security system or beneficiaries of such a system (excluding State Medical Assistance)\n* Patients who have given their informed consent\n* No significant expected changes in the administration of anxiolytic and analgesic treatments with anti-dyspneic properties within 2 days\n\nExclusion Criteria:\n\n* Pregnant women (verified by a blood or urine test during hospitalization for all women of childbearing age)\n* Patients deprived of liberty or under legal protection (guardianship or curatorship)\n* Patients unable to consent to the research\n* Contraindication to the use of a 7 mm tracheostomy tube\n* Patient presenting the combination of major swallowing disorders and excessive salivary secretion making the deflation of the tracheostomy tube balloon","ALL","18 Years",{"count":58,"type":59},76,"ESTIMATED","INTERVENTIONAL",[62],"NA","This trial aims to assess dyspnea intensity in tracheostomized patients undergoing prolonged artificial ventilation weaning. The primary outcome is dyspnea measured by the Visual Analogue Scale (VAS-Dyspnea). A comparison between low-pressure balloon tracheostomy cannula and plated balloon cannula and four interfaces (Cap, ventilator, phonation valve, or filter) are tested. The secondary outcomes including Multidimensional Dyspnea Profile, pain, anxiety VAS, and tolerance under different interfaces. The multicenter, cross-over study involves 76 patients over 25 months, each serving as their own control. Cap is always evaluated first but the order of the three interfaces (ventilator, phonation valve, or filter) and type of cannula are chosen by randomization. The study is conducted in three weaning centers (SRPR units) at Pitié-Salpêtrière, Bligny, and Forcilles.",[65],"Prolonged Weaning",[67,68,69],"prolonged weaning","tracheostomy","dyspnea","NOT_YET_RECRUITING","2024-07-18",{"date":73,"type":74},"2024-07-19","ACTUAL",{"date":76,"type":59},"2024-09",{"date":78,"type":59},"2026-10",{"name":5,"class":6}]