[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100477083":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":33,"locations":43,"responsibleParty":162,"collaborators":24,"id":165,"slug":24,"hasResults":166,"nctId":167,"briefTitle":168,"officialTitle":168,"acronym":24,"eligibilityCriteria":169,"healthyVolunteers":166,"sex":170,"minAge":171,"maxAge":172,"enrollmentInfo":173,"targetDuration":24,"studyType":176,"phases":177,"briefSummary":179,"conditions":180,"keywords":24,"overallStatus":46,"whyStopped":24,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},{"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",[44,58,70,81,93,105,118,128,142,150],{"facility":45,"status":46,"city":47,"state":24,"zip":24,"country":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Chu-Brugmann","RECRUITING","Brussels","Belgium",{"type":50,"coordinates":51},"Point",[52,53],4.34878,50.85045,{"lat":53,"lon":52},[56],{"name":57,"role":36,"phone":24,"phoneExt":24,"email":24},"Charalampos Pierrakos, Dr.",{"facility":59,"status":46,"city":60,"state":24,"zip":24,"country":61,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Bispebjerg Hospital","Copenhagen","Denmark",{"type":50,"coordinates":63},[64,65],12.56553,55.67594,{"lat":65,"lon":64},[68],{"name":69,"role":36,"phone":24,"phoneExt":24,"email":24},"Theis Skovsgaard Itenov, Dr.",{"facility":71,"status":46,"city":72,"state":24,"zip":24,"country":61,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Nordsjaellands Hospital","Hillerød",{"type":50,"coordinates":74},[75,76],12.30081,55.92791,{"lat":76,"lon":75},[79],{"name":80,"role":36,"phone":24,"phoneExt":24,"email":24},"Lars Hein, Drs.",{"facility":82,"status":46,"city":83,"state":24,"zip":24,"country":84,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Evaggelismos Hospital","Athens","Greece",{"type":50,"coordinates":86},[87,88],23.72784,37.98376,{"lat":88,"lon":87},[91],{"name":92,"role":36,"phone":24,"phoneExt":24,"email":24},"Eleni Ischaki, Dr.",{"facility":94,"status":46,"city":95,"state":24,"zip":24,"country":96,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Galway University Hospitals","Galway","Ireland",{"type":50,"coordinates":98},[99,100],-9.05095,53.27245,{"lat":100,"lon":99},[103],{"name":104,"role":36,"phone":24,"phoneExt":24,"email":24},"John Laffey, Prof.",{"facility":106,"status":46,"city":107,"state":108,"zip":24,"country":109,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Ospedale Generale Regionale F. Miulli","Acquaviva delle Fonti","Bari","Italy",{"type":50,"coordinates":111},[112,113],16.8433,40.89704,{"lat":113,"lon":112},[116],{"name":117,"role":36,"phone":24,"phoneExt":24,"email":24},"Marco Pezzuto, Drs.",{"facility":119,"status":46,"city":108,"state":24,"zip":24,"country":109,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari",{"type":50,"coordinates":121},[122,123],16.86982,41.12066,{"lat":123,"lon":122},[126],{"name":127,"role":36,"phone":24,"phoneExt":24,"email":24},"Claudio Zimatore, Drs.",{"facility":129,"status":46,"city":130,"state":131,"zip":132,"country":133,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Amsterdam UMC, location VUmc","Amsterdam","North Holland","1081HV","Netherlands",{"type":50,"coordinates":135},[136,137],4.88969,52.37403,{"lat":137,"lon":136},[140],{"name":141,"role":36,"phone":24,"phoneExt":24,"email":24},"Pieter Roel Tuinman, Dr.",{"facility":31,"status":46,"city":130,"state":131,"zip":143,"country":133,"cosmosGeoPoint":144,"geoPoint":146,"contacts":147},"1105 AZ",{"type":50,"coordinates":145},[136,137],{"lat":137,"lon":136},[148],{"name":149,"role":36,"phone":24,"phoneExt":24,"email":38},"Jante Sinnige, MD",{"facility":151,"status":46,"city":152,"state":24,"zip":24,"country":153,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Centralny Szpital Kliniczny MSWiA","Warsaw","Poland",{"type":50,"coordinates":155},[156,157],21.01178,52.22977,{"lat":157,"lon":156},[160],{"name":161,"role":36,"phone":24,"phoneExt":24,"email":24},"Konstanty Szuldrzynski, Prof.",{"type":32,"investigatorFullName":163,"investigatorTitle":164,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Prof. Dr. Marcus J. Schultz","Principal Investigator","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":174,"type":175},538,"ESTIMATED","INTERVENTIONAL",[178],"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.",[181,182,183],"ARDS, Human","Lung Ultrasound","Mechanical Ventilation","2026-05-22",{"date":186,"type":187},"2026-05-27","ACTUAL",{"date":189,"type":187},"2022-08-09",{"date":191,"type":175},"2027-11-01",{"name":5,"class":6},10]