[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"inhalational-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:inhalational-injury":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"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":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31],"Burn Injury","Inhalational Injury","Pulmonary Complications","Ventilator-induced Lung Injury (VILI)",[33,34,35,36,37],"Flow-controlled ventilation","Pressure-controlled ventilation","Mechanical Power","Dissipated Energy","Ventilator-induced lung injury","NOT_YET_RECRUITING","2025-06-18",{"date":41,"type":42},"2025-06-27","ACTUAL",{"date":44,"type":22},"2025-07",{"date":46,"type":22},"2028-06",{"name":48,"class":49},"University Hospital Bergmannsheil Bochum","OTHER"]