[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100477083":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":33,"locations":43,"responsibleParty":169,"collaborators":24,"id":172,"slug":173,"hasResults":174,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":24,"eligibilityCriteria":177,"healthyVolunteers":174,"sex":178,"minAge":179,"maxAge":180,"enrollmentInfo":181,"targetDuration":24,"studyType":184,"phases":185,"briefSummary":187,"conditions":188,"keywords":24,"overallStatus":46,"whyStopped":24,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Personalized ventilation","EXPERIMENTAL","If a patient is assigned to the intervention group, ventilator settings will be adjusted based on the lung morphology (focal or non focal) results of the lung ultrasound.",[13],"Other: Personalized ventilation",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard care","ACTIVE_COMPARATOR","Patients assigned to the control group will be ventilated according to the current standard of care.",[19],"Other: Standard care",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"Patients who are randomized for personalized ventilation with FOCAL ARDS will receive the following ventilator settings:\n\n* Positive end-expiratory pressure (PEEP) ≤ 9 cm water (H2O)\n* Tidal volume: 6 to 8 mL\u002Fkg predicted body weight (PBW)\n* Daily prone positioning\n\nLUS will be repeated every 48-72 hours in supine position for the focal ARDS patients to assess whether they have developed non-focal ARDS during admission. In that case, patients will from then on be treated according non-focal personalized treatment protocol.\n\nPatients who are randomized for personalized ventilation with Non-FOCAL ARDS will receive the following ventilator settings:\n\n* PEEP ≥ 15 cm H2O\n* Tidal volume: 4 to 6 mL\u002Fkg PBW\n* Daily recruitment maneuver",[9],null,{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Patient who are randomized in the control group will receive standard care\n\n* Tidal volume: 6 mL\u002Fkg PBW\n* PEEP and FiO2 according to the low PEEP and high fraction of inspired oxygen (FiO2) table of the AlVEOLI study\n* Prone positioning if the Partial Pressure of Oxygen (PaO2) \u002FFiO2 ratio is \\\u003C 150 mmHg",[15],[29],{"name":30,"affiliation":31,"role":32},"Lieuwe DJ Bos, Dr.","Amsterdam UMC, location AMC","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Jante S Sinnige, M.D.","CONTACT","+31637405311","j.s.sinnige@amsterdamumc.nl",{"name":40,"role":36,"phone":41,"phoneExt":24,"email":42},"Marry R Smit, Dr.","+3120 5666339","m.r.smit@amsterdamumc.nl",[44,59,72,83,96,109,123,133,148,156],{"facility":45,"status":46,"city":47,"state":24,"zip":24,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Chu-Brugmann","RECRUITING","Brussels","Belgium","BE",{"type":51,"coordinates":52},"Point",[53,54],4.34878,50.85045,{"lat":54,"lon":53},[57],{"name":58,"role":36,"phone":24,"phoneExt":24,"email":24},"Charalampos Pierrakos, Dr.",{"facility":60,"status":46,"city":61,"state":24,"zip":24,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Bispebjerg Hospital","Copenhagen","Denmark","DK",{"type":51,"coordinates":65},[66,67],12.56553,55.67594,{"lat":67,"lon":66},[70],{"name":71,"role":36,"phone":24,"phoneExt":24,"email":24},"Theis Skovsgaard Itenov, Dr.",{"facility":73,"status":46,"city":74,"state":24,"zip":24,"country":62,"countryCode":63,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Nordsjaellands Hospital","Hillerød",{"type":51,"coordinates":76},[77,78],12.30081,55.92791,{"lat":78,"lon":77},[81],{"name":82,"role":36,"phone":24,"phoneExt":24,"email":24},"Lars Hein, Drs.",{"facility":84,"status":46,"city":85,"state":24,"zip":24,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Evaggelismos Hospital","Athens","Greece","GR",{"type":51,"coordinates":89},[90,91],23.72784,37.98376,{"lat":91,"lon":90},[94],{"name":95,"role":36,"phone":24,"phoneExt":24,"email":24},"Eleni Ischaki, Dr.",{"facility":97,"status":46,"city":98,"state":24,"zip":24,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Galway University Hospitals","Galway","Ireland","IE",{"type":51,"coordinates":102},[103,104],-9.05095,53.27245,{"lat":104,"lon":103},[107],{"name":108,"role":36,"phone":24,"phoneExt":24,"email":24},"John Laffey, Prof.",{"facility":110,"status":46,"city":111,"state":112,"zip":24,"country":113,"countryCode":114,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Ospedale Generale Regionale F. Miulli","Acquaviva delle Fonti","Bari","Italy","IT",{"type":51,"coordinates":116},[117,118],16.8433,40.89704,{"lat":118,"lon":117},[121],{"name":122,"role":36,"phone":24,"phoneExt":24,"email":24},"Marco Pezzuto, Drs.",{"facility":124,"status":46,"city":112,"state":24,"zip":24,"country":113,"countryCode":114,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari",{"type":51,"coordinates":126},[127,128],16.86982,41.12066,{"lat":128,"lon":127},[131],{"name":132,"role":36,"phone":24,"phoneExt":24,"email":24},"Claudio Zimatore, Drs.",{"facility":134,"status":46,"city":135,"state":136,"zip":137,"country":138,"countryCode":139,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Amsterdam UMC, location VUmc","Amsterdam","North Holland","1081HV","Netherlands","NL",{"type":51,"coordinates":141},[142,143],4.88969,52.37403,{"lat":143,"lon":142},[146],{"name":147,"role":36,"phone":24,"phoneExt":24,"email":24},"Pieter Roel Tuinman, Dr.",{"facility":31,"status":46,"city":135,"state":136,"zip":149,"country":138,"countryCode":139,"cosmosGeoPoint":150,"geoPoint":152,"contacts":153},"1105 AZ",{"type":51,"coordinates":151},[142,143],{"lat":143,"lon":142},[154],{"name":155,"role":36,"phone":24,"phoneExt":24,"email":38},"Jante Sinnige, MD",{"facility":157,"status":46,"city":158,"state":24,"zip":24,"country":159,"countryCode":160,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Centralny Szpital Kliniczny MSWiA","Warsaw","Poland","PL",{"type":51,"coordinates":162},[163,164],21.01178,52.22977,{"lat":164,"lon":163},[167],{"name":168,"role":36,"phone":24,"phoneExt":24,"email":24},"Konstanty Szuldrzynski, Prof.",{"type":32,"investigatorFullName":170,"investigatorTitle":171,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Prof. Dr. Marcus J. Schultz","Principal Investigator","100477083","personalized-mechanical-ventilation-guided-by-ultrasound-in-patients-with-acute-respiratory-distress-syndrome-100477083",false,"NCT05492344","Personalized Mechanical Ventilation Guided by UltraSound in Patients With Acute Respiratory Distress Syndrome","Inclusion Criteria:\n\n* Admitted to a participating ICU,\n* invasively ventilated and\n* fulfil the Berlin criteria for moderate or severe ARDS.\n\nExclusion Criteria:\n\n* Age under 18,\n* participation in other interventional studies with conflicting endpoints,\n* conditions in which LUS is not feasible or possible (e.g. subcutaneous emphysema, morbid obesity or wounds),\n* mechanical ventilation for longer than 7 consecutive days in the past 30 days,\n* history of ARDS in the previous month,\n* body-mass index higher than 40 kg\u002Fm²,\n* intracranial hypertension,\n* broncho-pleural fistula,\n* chronic respiratory diseases requiring long-term oxygen therapy or respiratory support,\n* pulmonary fibrosis with a vital capacity \\\u003C 50% (severe or very severe),\n* previously randomized in the PEGASUS study\n* ECMO\n* patients who receive invasive ventilation in home setting due to a neurological disease\n* pregnant patients\n* patients who are moribund or facing end of life and\n* no informed consent.","ALL","18 Years","100 Years",{"count":182,"type":183},538,"ESTIMATED","INTERVENTIONAL",[186],"NA","Rationale Acute respiratory distress syndrome (ARDS) is a frequent cause of hypoxemic respiratory failure with a mortality rate of approximately 30%. The identification of ARDS phenotypes, based on focal or non-focal lung morphology, can be helpful to better target mechanical ventilation strategies of individual patients. Lung ultrasound (LUS) is a non-invasive tool that can accurately distinguish 'focal' from 'non-focal' lung morphology. The investigators hypothesize that LUS-guided personalized mechanical ventilation in ARDS patients will lead to a reduction in 90-day mortality compared to conventional mechanical ventilation.",[189,190,191],"ARDS, Human","Lung Ultrasound","Mechanical Ventilation","2026-05-22",{"date":194,"type":195},"2026-05-27","ACTUAL",{"date":197,"type":195},"2022-08-09",{"date":199,"type":183},"2027-11-01",{"name":5,"class":6},10]