[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ASST Sette Laghi\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100583040","three-different-ghdt--goal-hemodynamic-directed-therapy-strategies-for-intraoperative-fluid-management-optimization-during-major-abdominal-surgery-a-randomized-controlled-trial-100583040",false,"NCT06871150","Three Different GHDT ( Goal Hemodynamic Directed Therapy) Strategies for Intraoperative Fluid Management Optimization During Major Abdominal Surgery: A Randomized Controlled Trial","Surgical Management and Advanced Real Time Technologies for Fluid Optimization in Major Abdominal Surgery: A Randomized Controlled Trial","SMART FLUID","Inclusion Criteria:\n\n* Age ≥ 65 years.\n* ASA physical status II-III-IV.\n* Patients undergoing elective major abdominal oncological surgery.\n* Revised Cardiac Index Score ≥ 2.\n* Plan to perform the procedure with invasive arterial monitoring.\n* Expected surgical time greater than 120 minutes.\n\nExclusion Criteria:\n\n* Emergency or urgent surgeries.\n* Severe chronic renal failure (creatinine clearance \\\u003C 30 ml\u002Fmin).\n* Chronic heart failure (NYHA Class IV).\n* Pregnant women.\n* Contraindications to pulse contour hemodynamic monitoring.\n* Liver surgery.\n* Patient refusal.","ALL","65 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"NA","Major oncological surgery is among the most complex procedures, involving patients with a combination of high-risk factors that can significantly influence immediate postoperative outcomes and quality of life. The intraoperative hemodynamic management of these patients represents a crucial challenge: maintaining cardiovascular stability and fluid balance during the surgery is associated with reduced complications, including acute kidney injury, myocardial ischemia, and sepsis. Literature has shown that intraoperative fluid administration guided by specific algorithms can reduce complications and improve patient outcomes.\n\nIn recent years, innovations in artificial intelligence (AI) have profoundly changed how hemodynamic variables are managed during surgery. AI enables real-time clinical data processing and offers the possibility to predict imminent hypotension episodes, allowing the medical team to intervene proactively. An example of such technologies is the Hypotension Prediction Index (HPI), which uses a machine learning algorithm to analyze hemodynamic data and predict the risk of hypotension with up to 80% accuracy, up to 10 minutes before it occurs. Therefore, softwares that integrate fluid administration volumes with parameters derived from pulse contour systems are used currently, enabling an analysis of the efficacy of administration of fluid boluses. For example, the Assisted Fluid Management (AFM) software helps the clinician in choosing the timing of fluid administration, determining its effectiveness in terms of fluid responsiveness. This allows to reduce complications related to improper intraoperative fluid management, such as organ damage, and optimize the use of fluids and vasopressor drugs.\n\nDespite the growing use of AI in surgery, the clinical and economic impact of such technologies is still under study. Advanced intraoperative hemodynamic management tools have been shown to reduce the duration of hypotensive episodes and improve hemodynamic stability. The clinical impact of such monitoring, in terms of complications and length of postoperative stay, could be crucial to recommend their use in high-risk patient cohorts. This aligns with medical literature showing that postoperative complications increase patient-related hospitalization costs. This study aims to explore the utility of combining a Goal-Directed Hemodynamic Therapy (GDHT) protocol with AI software in three different scenarios.\n\nThe primary objective of the study is to evaluate if there is a significant difference in intraoperative fluid administration volumes across three different protocols of GDHT supported by AI, in patients undergoing major abdominal oncological surgery.\n\nThe study's secondary objectives include:\n\n* Assess the rate of hypotensive episodes in terms of Time-Weighted Average Hypotension (TWAH) across the three groups.\n* Analyze the rate of postoperative complications and hospital mortality across the three groups.\n* Evaluate the total hospital stay duration and\u002For the number of days spent in intensive care across the three groups.\n\nThe study aims to provide evidence on the clinical efficacy of haemodynamic monitoring technologies currently present in daily practice. The results will allow us to define an optimization of intraoperative haemodynamic management, improving clinical outcomes and optimizing the use of healthcare resources.",[27],"Hemodynamic",[29],"GHDT, Hypotension prediction, Assisted Fluid Management","RECRUITING","2026-03-21",{"date":33,"type":34},"2026-03-25","ACTUAL",{"date":36,"type":21},"2026-03-02",{"date":38,"type":21},"2026-10-30",{"name":40,"class":41},"ASST Sette Laghi","OTHER",3,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100600798","comparison-of-loco-regional-analgesic-techniques-in-patients-undergoing-video-assisted-thoracoscopic-surgery-vats-100600798","NCT07102173","Comparison of Loco-regional Analgesic Techniques in Patients Undergoing Video Assisted Thoracoscopic Surgery (VATS)","Management Protocol for Comparison of Loco-regional Analgesic Techniques in Patients Undergoing Video Assisted Thoracoscopic Surgery (VATS)","PRoGEVATS","Inclusion Criteria:\n\n* Adult patients\n* Signed informed consent\n* Elective unilateral surgery\n\nExclusion Criteria:\n\n* Minor patients\n* BMI \\> 40\n* Unstable neurological disorders\n* Known allergy to acetaminophen and NSAIDs\n* Chronic renal failure (stage \\> 4, whith GFR between 29 and 15 mL\u002Fmin)\n* Patient refusal\n* Chronic use of NSAIDs and opioids in the 3 months prior to surgery\n* Contraindications to peripheral block (infection al the insertion site, allergy to local anesthetics, severe coagulation disorders)","18 Years",{"count":53,"type":21},72,[24],"This study aims to compare two loco-regional analgesic techniques:\n\n1. Intercostal nerve block: Performed by the surgeon intraoperatively before final lung re-expansion, involving the administration of 20 mL of 0.5% levobupivacaine using a 27G needle into the subpleural space of the thoracotomy access site and adjacent intercostal spaces.\n2. Ultrasound-guided ESPB: Performed by an anesthesiologist under surgical asepsis with the patient in a seated position. After identifying the target transverse process, a linear ultrasound probe is placed sagittally approximately 2 cm from the midline. The needle (22G, 50 mm) is inserted in-plane in a cranio-caudal direction until contacting the transverse process. After confirming proper injection by observing anesthetic spread between the erector spinae muscle and transverse process, a total of 30 mL of 0.375% ropivacaine is administered.\n\nThis protocol is intended for patients undergoing video-assisted thoracoscopic surgery (VATS) for pneumonectomies, lobectomies, wedge resections, and bullectomies.\n\nPrimary Endpoint:QoR Score at 24 hours (validated questionnaires. Secondary Endpoints: Intraoperative NOL, QoR at 48-72 hours, opioid consumption at 12-24-48 hours, NLR at 24 hours, CPSP incidence at 3 months.",[57],"Loco-regional Anesthesia",[59,60,61,62,63],"VATS","post-operative analgesia","loco-regional anesthesia","ESPB","Intercostal nerve block","NOT_YET_RECRUITING","2025-07-28",{"date":67,"type":34},"2025-08-03",{"date":69,"type":21},"2025-08-01",{"date":71,"type":21},"2026-04",{"name":40,"class":41},""]