[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581261":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":48,"collaborators":18,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":18,"enrollmentInfo":61,"targetDuration":18,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":74,"whyStopped":18,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Policlinico Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Automated endotracheal cuff controller","EXPERIMENTAL","The endotracheal tube cuff pressure will be continuously controlled by the Trachflush system, at pre-specifed pressure level of 25 cmH20.",[13],"Device: Automated endotracheal cuff controller",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group (analogic manometer)","NO_INTERVENTION","The endotracheal cuff will be inflated at 25 cmH20 manually by an analogic manometer. Every 8 hours analogic manometry will be performed to assess cuff pressure.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"DEVICE","The automated endotracheal tube cuff pressure controller will continously assess and maintain the endotracheal tube cuff pressure at pre-specifed pressure level of 25 cmH20.",[9],[25],{"name":26,"affiliation":27,"role":28},"Alberto Zanella, MD","Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","STUDY_CHAIR",[30],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Irene Zainaghi, PhD","CONTACT","+39 0255033275","irene.zainaghi@policlinico.mi.it",[36],{"facility":37,"status":18,"city":38,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":18},"Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico","Milan","20122","Italy","IT",{"type":43,"coordinates":44},"Point",[45,46],9.18951,45.46427,{"lat":46,"lon":45},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Giacomo Grasselli","Prof","100581261","tracheal-cuff-pressure-evaluation-study-100581261",false,"NCT06848010","TRacheal Cuff PRessure Evaluation Study","TRAC-PRES","Inclusion Criteria:\n\n* Required invasive mechanical ventilation expected to last for more than 24h\n* Signed informed consent\n\nExclusion Criteria:\n\n* Intubated from more than 6 hours at the time of screening\n* Pregnancy\n* Previous surgery involving the airways","ALL","18 Years",{"count":62,"type":63},54,"ESTIMATED","INTERVENTIONAL",[66],"NA","Randomized clinical trial in mechanically ventilate critically ill patients. The study will evaluated the efficacy of a continous endotracheal tube (ETT) cuff pressure controller (TRACH FLUSH group) compared to manual monitoring and inflation (STANDARD group).\n\nPatients intubated, from at least 24 hours and with a predicted duration of invasive mechanical ventilation longer than 72 hours, will be randomized to the use of TRACH FLUSH versus nurse operated analogic cuff pressure controller q8.\n\nHypotesis of the study is the superiority of the continuous cuff pressure controller in maintaining cuff pressure within the target value, thus decreasing the incidence of microaspiration events.\n\nAim of the study are 1) to compare the incidence of cuff pressure value detection outside the target range between the TRACH FLUSH and the STANDARD group, and 2) to compare the incidence of sputum samples positive for (amylase and\u002For pepsin), a surrogate for tracheal micro-aspiration event.",[69,70],"Pneumonia, Ventilator-Associated","Mechanical Ventilation",[72,73],"pressure cuff control","mechanical ventilation","NOT_YET_RECRUITING","2026-01-26",{"date":77,"type":78},"2026-01-28","ACTUAL",{"date":80,"type":63},"2026-02-15",{"date":82,"type":63},"2027-12-31",{"name":5,"class":6},1]