[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547645":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":33,"locations":43,"responsibleParty":63,"collaborators":24,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":24,"enrollmentInfo":75,"targetDuration":24,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":46,"whyStopped":24,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Charles University, Czech Republic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"72-hour HME exchange interval group","EXPERIMENTAL","Intervention group: daily care will be provided according to the local standards, with an HME exchange interval every 72 hours",[13],"Other: 72-hour HME exchange interval group",{"label":15,"type":16,"description":17,"interventionNames":18},"24-hour HME exchange interval group","ACTIVE_COMPARATOR","Control group: daily care will be provided according to the local standards, with an HME exchange interval every 24 hours",[19],"Other: 24-hour HME exchange interval group",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"All patients in the experimental arm will receive the usual best medical and nursing care with respect to VAP prevention. A dual-limb ventilator circuit with a closed suction system will be used. Bronchodilation or inhalational antibiotics, when ordered, will be delivered by a meshed nebuliser, a part of the ventilatory support circuit and will not be removed between treatments. A closed-circuit suction device will be used, and the frequency of suctioning will be monitored, including the sputum consistency and blood on suctioning. HME filter resistance by estimating the pressure drop over HME using the ventilatory circuit's auxiliary force (Paux) and flow. Temperature and humidity in the ventilator circuit will be measured. HME filters will be exchanged every 72 hours. At the exchange point, both outlets of the HME filter will be swabbed.",[9],null,{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"All patients in the control arm will receive the usual best medical and nursing care with respect to VAP prevention. A dual-limb ventilator circuit with a closed suction system will be used. Bronchodilation or inhalational antibiotics, when ordered, will be delivered by a meshed nebuliser, a part of the ventilatory support circuit and will not be removed between treatments. A closed-circuit suction device will be used, and the frequency of suctioning will be monitored, including the sputum consistency and blood on suctioning. HME filter resistance by estimating the pressure drop over HME using the ventilatory circuit's auxiliary force (Paux) and flow. Temperature and humidity in the ventilator circuit will be measured. HME filters will be exchanged every 24 hours. At the exchange point, both outlets of the HME filter will be swabbed.",[15],[29],{"name":30,"affiliation":31,"role":32},"Kateřina Jiroutková","3rd Faculty of Medicine, Charles University and FNKV, Prague","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Šárka Línková","CONTACT","+420 723 638 719","sarka.franta@seznam.cz",{"name":40,"role":36,"phone":41,"phoneExt":24,"email":42},"Adéla Jiroudkova","+420 602 145 168","adela.jiroudkova@ruk.cuni.cz",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":24,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"3rd Faculty of Medicine and FNKV","RECRUITING","Prague","Česká Republika","110 00","Czechia",{"type":52,"coordinates":53},"Point",[54,55],14.42076,50.08804,{"lat":55,"lon":54},[58,59],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},{"name":60,"role":36,"phone":61,"phoneExt":24,"email":62},"Kateřina Jiroutková, MD","+420 724 259 492","katka.nova@post.cz",{"type":32,"investigatorFullName":30,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Kateřina Jiroutková, MD, PhD, DESAIC, Charles University, Czech Republic, Principal Investigator","100547645","efficiency-and-safety-of-the-prolonged-use-of-heat-and-moisture-exchangers-in-icu-100547645",false,"NCT06410664","Efficiency and Safety of the Prolonged Use of Heat and Moisture Exchangers in ICU","Safety and Efficiency of the Prolonged (72-hour) Use of a Single Heat and Moisture Exchanger in Adult Mechanically Ventilated Critically Ill and Its Impact on the Lower Respiratory Tract Pathogenic Microbial Colonisation Rate (FILTRex Trial); a Single-centre, Randomised, Controlled Trial","FILTRex","Inclusion Criteria:\n\n1. Age ≥18 years\n2. In-patient in ICU and expected to stay \\> 3 days\n3. Mechanical ventilation or imminent need of it; predicted length of mechanical ventilation ≥ 72h\n4. Clinical Pulmonary Infection score (CPIS) less than six at the baseline 5 No history and symptoms of aspiration at the baseline\n\nExclusion Criteria:\n\n1. Suspected pulmonary infection on admission and in the first 48 hours of mechanical ventilation\n2. Pregnancy\n3. Acute respiratory distress syndrome\n4. Body temperature \\\u003C 32°C\n5. Airway bleeding or other contraindications for the use of HME\n6. An early decision of treatment withdrawal","ALL","18 Years",{"count":76,"type":77},120,"ESTIMATED","INTERVENTIONAL",[80],"NA","FILTRex is a single-centre, controlled, randomised, prospective, non-inferiority clinical trial to compare the efficiency and safety of prolonged (72-hours) versus standard (24-hours) duration of use for Heat and Moisture Exchange (HME) filters in adult mechanically ventilated critically ill patients",[83],"VAP - Ventilator Associated Pneumonia",[85,86,87,88],"pneumonia","Heat and Moisture Exchange (HME) filter","VAP bundle in ICU","endotracheal tube occlusion","2024-07-25",{"date":91,"type":92},"2024-07-26","ACTUAL",{"date":94,"type":92},"2024-05-01",{"date":96,"type":77},"2026-06",{"name":5,"class":6},1]