[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564340":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":10,"centralContacts":24,"locations":10,"responsibleParty":30,"collaborators":10,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":36,"acronym":37,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":10,"enrollmentInfo":41,"targetDuration":44,"studyType":45,"phases":10,"briefSummary":46,"conditions":47,"keywords":49,"overallStatus":54,"whyStopped":10,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":10},{"fullName":5,"class":6},"Humanitas Clinical and Research Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1",null,"Patients receiving a fluid challenge",[13,14],"Other: fluid challenge","Diagnostic Test: end-expiratory occlusion test",[16,20],{"type":6,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"fluid challenge","The study protocol is started during a period of intraoperative hemodynamic stability, as previously defined (i.e. change in mean arterial pressure of less than 10% during 5 minutes \\[32, 33\\]). The study protocol is was the following: 1) a set of measurements was recorded (T0) at a baseline 2) (T1) after one minute the EEOT is then performed by stopping the mechanical ventilation for 30 seconds (T2 - end of the EEOT test); 3) (T3) a FC of overall 6 mL\u002FKg of crystalloid solution is infused over 10 minutes (T4 end of the FC). The attending anesthetist is allowed to interrupt the protocol at any stage for either hemodynamic instability or any other adverse effects requiring urgent treatment.\n\nThe protocol is entirely intraoperative and data collections ends after FC administration. No follow-up is needed.\n\nThe mentioned timepoints T0 - T1 - T2, corresponding to intrapeortive data recording points are also the endpoints of the study. At each specific timepoint, a marker is added to the M",[9],{"type":21,"name":22,"description":18,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","end-expiratory occlusion test",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Antonio Messina, PhD","CONTACT","+390282241","antonio.messina@humanitas.it",{"type":31,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100564340","hemodynamic-response-to-the-end-expiratory-occlusion-test-to-titrate-fluid-challenge-in-operating-room-100564340",false,"NCT06627907","Hemodynamic Response to the End-expiratory Occlusion Test to Titrate Fluid Challenge in Operating Room.","FC_EEOT","Inclusion Criteria:\n\n1. Adult patients aged ≥ 18 years\n2. Scheduled for elective supine abdominal laparotomic or neuro surgery, requiring invasive arterial monitoring and continuous hemodynamic monitoring\n3. All the patients must be able to sign an informed consent at the admission\n\nExclusion Criteria:\n\n1. Any recurrent cardiac arrhythmias\n2. Reduced left (ejection fraction \\\u003C30%) or right (systolic peak velocity of tricuspid annular motion \\\u003C0.17 m\u002Fs) ventricular systolic function\n3. Urgent \u002F Emergent surgery\n4. Liver surgery\n5. Laparoscopic surgery","ALL","18 Years",{"count":42,"type":43},300,"ESTIMATED","1 Day","OBSERVATIONAL","Personalzing intraoperative anesthetic fluid management may help in preventing fluid accumulation and related complications.\n\nFluids are gine as boluses in operating room (the so-called FC). The response to the FC is due to several physiological conditions related to the \"preload dependency\" (i.e. the intrinsic ability of the heart of increasing the stroke volume - SV - in response to fluid administration).\n\nThe minimal volume required to appropriately \"challenge\" the cardiovascular system is 4 ml\u002Fkg of fluid, but higher volumes (up to 6 ml\u002Fkg may be needed).\n\nPredicting the response to FC administration may be possible by applying a physiological test (called functional hemodynamic test), such as the end-expiratory occlusion test, consisting in interrupping the mechanical ventilation and hence promoting venous return and consequente SV changes. The percentage of SV increase associated to EEOT may predict fluid responsiveness to the FC (patients responders will increase SV to a bigger extent, as compared to non-responders)",[48],"Fluid Responsiveness Predictability",[50,51,52,53],"Fluid challenge","End-expiratory occlusion test","FLuid responsiveness","Surgery","NOT_YET_RECRUITING","2024-10-03",{"date":57,"type":58},"2024-10-08","ACTUAL",{"date":60,"type":43},"2024-11-01",{"date":62,"type":43},"2026-09-01",{"name":5,"class":6}]