[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614516":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":17,"armGroups":25,"interventions":37,"overallOfficials":17,"centralContacts":17,"locations":43,"responsibleParty":63,"collaborators":17,"id":67,"slug":17,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":17,"enrollmentInfo":75,"targetDuration":17,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":46,"whyStopped":17,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Policlinico Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"THBR\u002FTSPONT ratio","Comparison of the ratio between the diaphragm electrical activation time after a high-volume breath aimed at eliciting the HBR (THBR) and a spontaneous breath (TSPONT), i.e., the THBR\u002FTSPONT ratio, between patients who underwent bilateral lung transplantation and those who underwent non-thoracic surgery.","At the enrollment",[14],{"measure":15,"description":16,"timeFrame":12},"The variation of the THBR\u002FTSPONT ratio as a function of PEEP","Variation of the THBR\u002FTSPONT ratio calculated at two different PEEP levels (8 and 12 cmH₂O) in patients who underwent bilateral lung transplantation and in those who underwent non-thoracic surgery.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"NON_RANDOMIZED","PARALLEL","The study will be conducted on two groups of subjects:\n\n* Patients admitted to the Intensive Care Unit for post-operative care following bilateral lung transplantation (Group 1);\n* Patients admitted to the Intensive Care Unit for post-operative care or monitoring after non-thoracic surgery (Group 2 - control group)","BASIC_SCIENCE",{"masking":24,"maskingDescription":17,"whoMasked":17},"NONE",[26,32],{"label":27,"type":28,"description":29,"interventionNames":30},"Bilateral Lung Transplant patients","EXPERIMENTAL","This group include patients admitted to the Intensive Care Unit for post-operative care following bilateral lung transplantation during the weaning phase from mechanical ventilation. The following patients will be excluded: minors, those undergoing retransplantation, single-lung transplantation or urgent lung transplantation; patients with respiratory system compliance \\\u003C 30 mL\u002FcmH2O; haemodynamically unstable patients and those at increased risk of bleeding due to nasogastric tube placement.",[31],"Device: Nasogastric tube placement and elicitation of Hering-Breuer reflex",{"label":33,"type":34,"description":35,"interventionNames":36},"Non-thoracic surgery patients","ACTIVE_COMPARATOR","This group include patients admitted to the Intensive Care Unit for post-operative care or monitoring after non-thoracic surgery. The following patients will be excluded: minors, those who had undergone previous lung transplant or thoracic surgery; patients with respiratory system compliance \\\u003C 30 mL\u002FcmH2O; haemodynamically unstable patients; those at increased risk of bleeding due to nasogastric tube placement and patients with contraindications to nasogastric tube placement.",[31],[38],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":17},"DEVICE","Nasogastric tube placement and elicitation of Hering-Breuer reflex","Enrolled patients will have a nasogastric tube placed, through which diaphragmatic electrical activity will be measured. Patients will be ventilated in pressure support mode with an expansion breath delivered at a maximum pressure of approximately 30 cmH2O in order to elicit the Hering-Breuer Reflex. Diaphragmatic electrical activity, timing, volumes and pressures will then be analyzed before and after the expansion breath over a 10 minute period, testing two levels of PEEP (8 and 12 cmH2O).",[27,33],[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico","RECRUITING","Milan","Michigan","20122","Italy","IT",{"type":53,"coordinates":54},"Point",[55,56],12.59836,42.78235,{"lat":56,"lon":55},[59],{"name":45,"role":60,"phone":61,"phoneExt":17,"email":62},"CONTACT","+39 0255033285","alessio.caccioppola@policlinico.mi.it",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Giacomo Grasselli","Head of department of Anestesia and Intensive care unit","100614516",false,"NCT07280611","The Hering-Breuer Reflex in Bilateral Lung Transplant Patients","HB-DLTX","Inclusion Criteria:\n\n* Age \\>18 years;\n* Both sexes;\n* For group 1: patients admitted to the Intensive Care Unit after undergoing bilateral lung transplantation, during respiratory weaning;\n* For group 2: patients admitted to the Intensive Care Unit for support or monitoring after non-thoracic surgery, who will arrive intubated.\n\nExclusion Criteria:\n\nFor group 1, patients meeting at least one of the following criteria will be excluded:\n\n* Re-transplantation or single-lung transplantation;\n* Urgent lung transplantation;\n* Post-transplant respiratory system compliance \\\u003C 30 mL\u002FcmH₂O;\n* Hemodynamic instability (defined as the presence of one or more of the following: plasma lactate \\> 4 mmol\u002FL, need for vasoactive support with norepinephrine and\u002For epinephrine at a dose \\> 0.05 mcg\u002Fkg\u002Fmin, systolic arterial pressure \\\u003C 80 mmHg);\n* Increased risk of bleeding related to the placement of a nasogastric tube due to coagulopathy or severe thrombocytopenia (INR \\> 2 and platelets \\\u003C 70,000);\n* Pregnancy\n\nFor group 2, patients presenting with one or more of the following criteria will be excluded:\n\n* Postoperative respiratory system compliance \\\u003C 30 mL\u002FcmH₂O;\n* Hemodynamic instability (defined as the presence of one or more of the following: plasma lactate \\> 4 mmol\u002FL, need for vasoactive support with norepinephrine and\u002For epinephrine at a dose \\> 0.05 mcg\u002Fkg\u002Fmin, systolic arterial pressure \\\u003C 80 mmHg);\n* Contraindications to nasogastric tube placement (gastroesophageal surgery within the last 3 months, gastroesophageal bleeding in the previous 30 days, esophageal varices, facial trauma);\n* Increased risk of bleeding related to the placement of a nasogastric tube due to coagulopathy or severe thrombocytopenia (INR \\> 2 and platelets \\\u003C 70,000);\n* History of lung transplantation or major thoracic surgery;\n* Pregnancy.","ALL","18 Years",{"count":76,"type":77},22,"ESTIMATED","INTERVENTIONAL",[80],"NA","The goal of this clinical trial (non-pharmacologic, single-center) is to determine whether the Hering-Breuer inflation reflex is preserved-and how it is modulated by end-expiratory pressure-in adult intensive-care patients who have undergone bilateral lung transplantation.\n\nThe study will enroll men and women ≥ 18 years admitted to the ICU during the early weaning phase and will include a comparison group of intubated ICU patients after major non-thoracic surgery.\n\nThe main questions it aims to answer are:\n\n* Is the Hering-Breuer reflex (measured as the ratio THBR\u002FTSPONT) absent or attenuated in double-lung-transplant recipients?\n* Does changing the level of positive end-expiratory pressure (PEEP 8 vs 12 cmH₂O) influence the reflex?\n\nComparison group: Researchers will compare the transplant arm (post-bilateral lung transplantation) with the control arm (post-operative, non-thoracic surgery patients) to see whether loss or blunting of the reflex-and its response to PEEP-differs between the two cohorts.\n\nParticipants will:\n\n* Have a nasogastric catheter with embedded electrodes positioned to record the electrical activity of the diaphragm (EAdi).\n* Be ventilated in pressure-support mode at two preset PEEP levels (8 cmH₂O and 12 cmH₂O) during the weaning phase.\n* Receive one standardized high-volume insufflation at \\~30 cmH₂O in each PEEP condition to elicit the reflex, while EAdi, airway pressures, inspiratory\u002Fexpiratory times, and tidal volumes are recorded for 10 minutes per level.",[83],"Hering-Breuer Reflex",[85,86],"Hering-Breuer reflex","Bilateral Lung Transplant","2025-12-01",{"date":89,"type":90},"2025-12-12","ACTUAL",{"date":92,"type":90},"2025-10-07",{"date":94,"type":77},"2026-06",{"name":5,"class":6},1]