[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596169":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":41,"locations":47,"responsibleParty":62,"collaborators":65,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":45,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":91,"overallStatus":97,"whyStopped":45,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University Hospital Bergmannsheil Bochum","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Flow-Controlled Ventilation","EXPERIMENTAL","Individualized flow-controlled ventilation (FCV) with a compliance-guided positive end-expiratory pressure (PEEP), a compliance-guided driving pressure (ΔP) resulting in a liberal tidal volume, and adjustment of airway flows and respiratory rates being required for normocapnia.",[13],"Other: Individualized flow-controlled ventilation strategy",{"label":15,"type":16,"description":17,"interventionNames":18},"Pressure-Controlled Ventilation via Biphasic Positive Airway Pressure Ventilation","ACTIVE_COMPARATOR","Conventional pressure-controlled ventilation via application of Biphasic Positive Airway Pressure (BIPAP) ventilation with a compliance-guided positive end-expiratory pressure (PEEP), a driving pressure (ΔP) for a tidal volume of 6-8 ml\u002Fkg predicted body weight, and adjustment of respiratory rates being required for normocapnia but no adjustment\u002Fcontrol of airway flows.",[19],"Other: Pressure-controlled ventilation strategy via the application of Biphasic Positive Airway Pressure ventilation",[21,27],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Individualized flow-controlled ventilation strategy","1. Compliance-guided PEEP trial: An incremental PEEP trial from 5 to 15 cmH2O in 2 cmH2O steps with a constant driving pressure (ΔP) will be performed. At the first PEEP level, the tidal volume is set to 6-8 ml\u002Fkg PBW. The best PEEP level is defined as the one with the highest dynamic compliance. Participants are ventilated with this PEEP level + 1-2 cmH2O for a reduction of lung de-recruitment and atelectrauma.\n2. Compliance-guided driving pressure (ΔP) trial: In the FCV group, an additional incremental ΔP trial in 1 cmH2O steps is initiated after the PEEP trial. This trial evaluates if the tidal volume increases (over-)proportional to the dynamic compliance on the previous ΔP level when the ΔP is increased by 1 cmH2O. In the FCV group, participants are ventilated with a ΔP consistent with the highest dynamic compliance ± 1-2 cmH2O. The compliance-guided PEEP and ΔP trials are repeated every 8 hours in order to account for changes in overall lung compliance.",[9],[26],"FCV",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Pressure-controlled ventilation strategy via the application of Biphasic Positive Airway Pressure ventilation","1. Compliance-guided PEEP trial: An incremental PEEP trial from 5 to 15 cmH2O in 2 cmH2O steps with a constant driving pressure (ΔP)will be performed. At the first PEEP level, the tidal volume is set to 6-8 ml\u002Fkg PBW. The best PEEP level is defined as the one with the highest dynamic compliance. Participants are ventilated with this PEEP level + 1-2 cmH2O for a reduction of lung de-recruitment and atelectrauma.\n2. The driving pressure (ΔP) is set to achieve a tidal volume of 6-8 ml\u002Fkg predicted body weight.\n\nThe compliance-guided PEEP trial is repeated every 8 hours in order to account for changes in overall lung compliance.",[15],[32],"PCV via BIPAP",[34,38],{"name":35,"affiliation":36,"role":37},"Peter K. Zahn, Prof. Dr. med., M.D.","Ruhr University Bochum, BG University Hospital Bergmannsheil, Department of Anesthesiology, Intensive Care and Pain Medicine","STUDY_DIRECTOR",{"name":39,"affiliation":36,"role":40},"Simon Becker, Jun.-Prof. Dr. med., M.D.","PRINCIPAL_INVESTIGATOR",[42],{"name":39,"role":43,"phone":44,"phoneExt":45,"email":46},"CONTACT","+49 234 - 302 6917",null,"simon.becker@rub.de",[48],{"facility":49,"status":45,"city":50,"state":45,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"BG University Hospital Bergmannsheil, Ruhr University Bochum","Bochum","44789","Germany","DE",{"type":55,"coordinates":56},"Point",[57,58],7.21648,51.48165,{"lat":58,"lon":57},[61],{"name":39,"role":43,"phone":44,"phoneExt":45,"email":46},{"type":40,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"Simon Becker","Jun.-Prof. Dr. med. Simon Becker, M.D.",[66],{"name":67,"class":6},"Ruhr University of Bochum","100596169","biphasic-positive-airway-pressure-ventilation-versus-flow-controlled-ventilation-in-burn-patients-100596169",false,"NCT07041957","Biphasic Positive Airway Pressure Ventilation Versus Flow-Controlled Ventilation in Burn Patients","Biphasic Positive Airway Pressure Ventilation Versus Flow-Controlled Ventilation in Burn Patients: A Monocentric, Randomized Controlled, Parallel Group Trial","BIFLOWBURN","Inclusion Criteria:\n\n* Body weight ≥ 40 kg\n* Invasive ventilation time ≤ 24 hours before admission to the burn ICU or indication for intubation and invasive ventilation within 48 hours after admission to the burn ICU\n* Estimated (further) invasive ventilation time ≥ 24 hours\n* Intervention start within 48 hours after admission to the burn ICU\n* Establishment of a central venous line and invasive blood pressure monitoring as part of the intensive care therapy before the intervention start\n* Signed informed consent from the participant, legal guardian, next of kin in incompetent patients, or an intensivist in charge and independent from the Trial Management Committee in incompetent patients without a representative of the patients will\n\nExclusion Criteria:\n\n* Participation in another interventional trial\n* Duration of invasive ventilation \\> 24 hours at the time point of admission to the burn ICU\n* Estimated (further) invasive ventilation time \\\u003C 24 hours\n* Patients being treated in the burn ICU for (suspected) severe skin reactions such as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)\n* Lack of consent from the participant, legal guardian, next of kin, or intensivist in charge to participate in the study","ALL","18 Years","80 Years",{"count":80,"type":81},24,"ESTIMATED","INTERVENTIONAL",[84],"NA","The goal of this clinical trial is to learn if the new ventilation mode flow-controlled ventilation (FCV) is a more protective mode of ventilation for adult patients after severe burn injury. The main question it aims to answer is:\n\nDoes FCV reduce the mechanical power (a key determinant of ventilator-induced lung injury) compared to conventional pressure-controlled ventilation (PCV) during ventilation of patients with burn injury?\n\nResearchers will compare FCV with PCV for up to 70 hours of ventilation to see if the mechanical power is reduced during ventilation of participants being in need of ventilation after severe burn injury.\n\nVentilation of participants will be controlled by either FCV or PCV. Group-specific ventilation will have the following characteristics:\n\n* FCV: Control of airway flows during inspiration and expiration, use of individualized lower and upper airway pressures and no fixed values for the volumes being inspired and expired (tidal volumes)\n* PCV: No control of airway flows during expiration, use of individualized lower airway pressures and upper airway pressures for a fixed tidal volume during each breath (6-8 ml\u002Fkg ideal body weight)\n\nIn total, at least 24 participants in need of ventilation after severe burn injury will be ventilated either with FCV (12 participants) or PCV (12 participants) for up to 70 hours.\n\nDuring ventilation mechanical power is computed according to certain ventilation parameters. Additionally, we evaluate organ functions of the cardiovascular systems, the lungs and other organs during and after the group-specific ventilation.",[87,88,89,90],"Burn Injury","Inhalational Injury","Pulmonary Complications","Ventilator-induced Lung Injury (VILI)",[92,93,94,95,96],"Flow-controlled ventilation","Pressure-controlled ventilation","Mechanical Power","Dissipated Energy","Ventilator-induced lung injury","NOT_YET_RECRUITING","2025-06-18",{"date":100,"type":101},"2025-06-27","ACTUAL",{"date":103,"type":81},"2025-07",{"date":105,"type":81},"2028-06",{"name":5,"class":6},1]