[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625506":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":34,"responsibleParty":60,"collaborators":11,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":11,"enrollmentInfo":73,"targetDuration":11,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":92,"whyStopped":11,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Lung collapse and overdistention crossing point PEEP","EXPERIMENTAL",null,[13],"Other: Change in PEEP",{"label":15,"type":10,"description":11,"interventionNames":16},"Low lung collapse PEEP",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Low lung overdistention PEEP",[13],[21],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"Change in PEEP","Patients will undergo a decremental PEEP trial to determine the crossing-point PEEP. Secondly, three PEEP levels (low collapse PEEP, low overdistention PEEP and crossing point between lung collapse and overdistention PEEP) will be compared in a randomized order with 30-minute steps",[15,18,9],[26],{"name":27,"affiliation":5,"role":28},"Domenico Luca Grieco, MD","PRINCIPAL_INVESTIGATOR",[30],{"name":27,"role":31,"phone":32,"phoneExt":11,"email":33},"CONTACT","+393397681623","dlgrieco@outlook.it",[35],{"facility":36,"status":11,"city":37,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Fondazione Policlinico Universitario A.Gemelli IRCCS","Rome","00168","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],12.51133,41.89193,{"lat":45,"lon":44},[48,49,51,54,56,58],{"name":27,"role":31,"phone":32,"phoneExt":11,"email":33},{"name":50,"role":28,"phone":11,"phoneExt":11,"email":11},"Massimo Antonelli, MD",{"name":52,"role":53,"phone":11,"phoneExt":11,"email":11},"Tommaso Rosà, MD","SUB_INVESTIGATOR",{"name":55,"role":53,"phone":11,"phoneExt":11,"email":11},"Antonio Maria Dell'Anna, MD",{"name":57,"role":53,"phone":11,"phoneExt":11,"email":11},"Simone Carelli, MD",{"name":59,"role":53,"phone":11,"phoneExt":11,"email":11},"Filippo Bongiovanni, MD",{"type":28,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"GRIECO DOMENICO LUCA","Medical Doctor, Principal Investigator","100625506","hemodynamic-effects-of-lung-collapse-and-overdistension-during-ards-100625506",false,"NCT07423520","HemodynamIc eFfects of Lung Collapse and overdIstension During ARDS","HemodynamIc eFfects of Lung Collapse and overdIstension in Patients With Moderate-to-seVEre Acute Respiratory Distress Syndrome: the HI-FIVE Physiologic Study","HI-FIVE","Inclusion Criteria:\n\n* acute respiratory failure with onset \\\u003C 1 week from a predisposing risk factor, such as pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, or shock;\n* bilateral opacities on chest radiography and computed tomography or bilateral B lines and\u002For consolidations on lung ultrasound not fully explained by effusions, atelectasis, or nodules\u002Fmasses;\n* pulmonary edema not exclusively or primarily attributable to cardiogenic pulmonary edema\u002Ffluid overload, and hypoxemia\u002Fgas exchange abnormalities not primarily attributable to atelectasis;\n* PaO2\u002FFiO2 ratio ≤ 200 during invasive controlled mechanical ventilation;\n\nExclusion Criteria:\n\n* age \\\u003C18 years;\n* pregnancy;\n* signs of barotrauma or documented pneumothorax;\n* severe tachycardia (HR \\> 120 bpm) and severe lacticaemia (lac \\> 4 mmol\u002FL)\n* pre-existing decompensated heart failure (NYHA class 3-4 and\u002For documented left ventricular ejection fraction \\\u003C 35%);\n* contraindications to EIT placing (open chest wounds, presence of cardiac pacemaker);\n* intubation as a result of an acute exacerbation of chronic pulmonary disease;\n* contraindications to esophageal balloon placement (high bleeding risk, esophageal varices).","ALL","18 Years",{"count":74,"type":75},20,"ESTIMATED","INTERVENTIONAL",[78],"NA","The management ARDS relies on ventilatory strategies aimed at limiting ventilator-induced lung injury (VILI). The setting of PEEP is still subject of debate, as randomized clinical trials comparing standardized higher versus lower PEEP strategies failed to demonstrate a clear survival advantage. Only few studies explored the hemodynamic effects of various PEEP levels depending on lung recruitability. Furthermore, the role of PEEP-mediated lung collapse and overdistention on patients' hemodynamics has yet to be elucidated. In this physiologic study, the association between EIT-measured lung collapse and overdistention and cardiac function will be explored, accounting for the individual potential for lung recruitment, partitioned respiratory mechanics and cardiac preload responsiveness. Three PEEP levels will be tested in a randomized, crossover fashion: PEEP corresponding to the crossing point between lung collapse and overdistention, PEEP associated with low lung collapse, PEEP associated with low lung overdistention.",[81,82],"ARDS","AHRF",[81,82,84,85,86,87,88,89,90,91],"acute respiratory distress syndrome","PEEP","collapse","overdistention","hemodynamics","heart-lung interactions","mechanical ventilation","randomized crossover trial","NOT_YET_RECRUITING","2026-02-14",{"date":95,"type":96},"2026-02-20","ACTUAL",{"date":98,"type":75},"2026-02-28",{"date":100,"type":75},"2027-05-01",{"name":5,"class":6},1]