[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614516":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":26,"responsibleParty":46,"collaborators":25,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":25,"enrollmentInfo":59,"targetDuration":25,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":29,"whyStopped":25,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Policlinico Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Device: Nasogastric tube placement and elicitation of Hering-Breuer reflex",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"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).",[9,15],null,[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico","RECRUITING","Milan","Michigan","20122","Italy","IT",{"type":36,"coordinates":37},"Point",[38,39],12.59836,42.78235,{"lat":39,"lon":38},[42],{"name":28,"role":43,"phone":44,"phoneExt":25,"email":45},"CONTACT","+39 0255033285","alessio.caccioppola@policlinico.mi.it",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Giacomo Grasselli","Head of department of Anestesia and Intensive care unit","100614516","the-hering-breuer-reflex-in-bilateral-lung-transplant-patients-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":60,"type":61},22,"ESTIMATED","INTERVENTIONAL",[64],"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.",[67],"Hering-Breuer Reflex",[69,70],"Hering-Breuer reflex","Bilateral Lung Transplant","2025-12-01",{"date":73,"type":74},"2025-12-12","ACTUAL",{"date":76,"type":74},"2025-10-07",{"date":78,"type":61},"2026-06",{"name":5,"class":6},1]