[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"postoperative-delirium-and-postoperative-cognitive-decline\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:postoperative-delirium-and-postoperative-cognitive-decline":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100636623","paro-agitation-study-100636623",false,"NCT07568093","PARO-agitation-study","Postoperative Agitation, Anxiety and Pain With the Use of the Robotic Tool PARO - A Prospective Randomised Study","Patient inclusion criteria:\n\n* ≥18 years of age\n* Elective visceral surgery\n* german-speaking\n* Patient is capable of giving informed consent\n\nPatient exclusion criteria:\n\n* Known dementia\n* Known immunodeficiency\n* Anacusia\n* Acute damage to the central nervous system\n* A preoperative systemic infection\n* Pre-existing severe immunosuppression or colonization with multidrug-resistant organisms (methicillin resistant Staphylococcus aureus (MRSA), quadruple multidrug-resistant Gram-negative pathogens (MRGN), Candida auris, vancomycin-resistant enterococci (VRE), and linezolid-resistant enterococci (LRE))\n* Postoperative systemic infection\n* Drug dependence\n* Known chronic pain syndrome","ALL","18 Years",{"count":19,"type":20},300,"ESTIMATED","INTERVENTIONAL",[23],"NA","Postoperative agitation is a common and serious complication in visceral and transplant surgery, associated with prolonged hospital stays and an increased risk of self-harm. Therefore, it is important to find an approach to improve the management of postoperative agitation and to reduce its duration and severity. The medical device \"PARO\" is a robotic seal that enables patient-robot-interaction. Patients respond to the device through verbal communication and motor responses, as well as facial expressions and gestures. The seal detects human interaction through audiovisual recognition, tactile sensors, and the integration of artificial intelligence. The aim of the study is to observe the use of \"PARO\" in patients undergoing elective visceral surgery and to analyze the occurence of agitation.\n\nA decrease in the incidence of postoperative agitation is to be expected in a cohort of patients undergoing visceral surgery who use PARO compared to a group of patients undergoing visceral surgery who do not use PARO.\n\nTo monitor the occurrence of postoperative agitation, a standardized screening will be conducted twice daily for three days using the Richmond Agitation-Sedation Scale (RASS). To assess postoperative pain, anxiety and delirium, the Numerical Pain Scale (NRS), the State-Trait-Anxiety-Inventory (STAI) and a delirium screening tool (3D-CAM\u002FCAM-ICU) are used by a trained study team. The occurrence of other neuropsychiatric symptoms and postoperative surgical complications will also be assessed.\n\nAdditionally, the interaction between PARO and the patients is analyzed regarding movements, reactions to haptic and auditory stimuli, and the frequency of interaction. Our approach involves quantitatively monitoring these metrics to collect sensor data from the robot and video recordings of the patients to identify facial expression and posture patterns. The use and acceptance of the robot on clinical wards by various professional groups are evaluated. The focus is particularly on nursing staff, who have the most interactions with patients. The project is complemented by a hygiene study examining how successfully the hygiene protocol is integrated into clinical routines and what challenges the use of PARO poses in an intensive care unit. The aim is also to examine the workflow and time-related aspects of its usage. The study will be submitted as a clinical trial of the medical device within its intended use, without any additional invasive or burdensome procedures, in accordance with the provisions of Section 15 of the Medical Practitioners Act (MBO).",[26,27,28,29],"Agitation","POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE","Anxiety After Surgery","Postoperative Pain",[31],"Agitation, postoperative Delirium, Anxiety","RECRUITING","2026-04-28",{"date":35,"type":36},"2026-05-05","ACTUAL",{"date":38,"type":36},"2025-12-15",{"date":40,"type":20},"2027-05",{"name":42,"class":43},"Hannover Medical School","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100570610","predicting-postoperative-delirium-with-heart-rate-variability-obtained-by-analgesia-nociception-index-100570610","NCT06709482","Predicting Postoperative Delirium With Heart Rate Variability Obtained by Analgesia Nociception Index","Predicting Postoperative Delirium With Heart Rate Variability Obtained by Analgesia Nociception Index - A Prospective Clinical Pilot Study","DANI","Inclusion Criteria:\n\n1. \\> 50 years of age\n2. Scheduled for elective moderate to major risk traumatology or orthopedic surgery (excluding spine surgery) and anticipated duration of general anaesthesia ≥ 60 minutes.\n\nExclusion Criteria:\n\n1. Delirium before surgery.\n2. Patients with emergency surgery\n3. Contraindication to general anesthesia\n4. ASA ≥ 4.\n5. Terminal disease.\n6. h\u002Fo documented dementia, MoCA Score \\\u003C18\n7. h\u002Fo atrial fibrillation\n8. h\u002Fo Parkinson´s disease \u002F Multiple system atrophy \u002F Pure autonomic failure\n9. h\u002Fo autonomic dysfunction (neurogenic autonomic dysfunction)\n10. h\u002Fo stroke\u002Fintracerebral hemorrhage\n11. Cerebral neoplasia\n12. h\u002Fo chronic central nervous disorder (e.g. multiple sclerosis)\n13. Major Depression\n14. Language, vision, or hearing impairments that may compromise delirium or cognitive assessments.\n15. h\u002Fo malignant hyperthermia\n16. h\u002Fo structural muscle disease\n17. h\u002Fo substance abuse\n18. h\u002Fo polyneuropathy\n19. h\u002Fo psychiatric disease\n20. h\u002Fo or current substance use disorder (DSM V)",true,"50 Years",{"count":56,"type":20},150,"OBSERVATIONAL","The aim of this pilot study is to establish a correlation between perioperative heart rate variability (HRV) as an expression of the shift in the balance of the autonomic nervous system and the occurrence of postoperative inflammation and delirium. The main question it aims to answer is: Do patient with increased sympathetic nervous system activity develop postoperative delirium (POD) more often than patients with increased parasympathetic tone?",[27,60,61],"Heart Rate Variability","Biomarkers",[63,64,65],"postoperative delirium","inflammation","heart rate variability","NOT_YET_RECRUITING","2025-03-06",{"date":69,"type":36},"2025-03-07",{"date":71,"type":20},"2025-03-01",{"date":73,"type":20},"2026-12-01",{"name":75,"class":43},"Medical University Innsbruck",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":53,"sex":16,"minAge":84,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100501251","investigate-the-association-between-viral-neurotoxic-infection-and-postoperative-delirium-and-postoperative-cognitive-decline-100501251","NCT05806827","INVESTIGATE THE ASSOCIATION BETWEEN VIRAL NEUROTOXIC INFECTION AND POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE","CONNECTED - INVESTIGATE THE ASSOCIATION BETWEEN VIRAL NEUROTOXIC INFECTION AND POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE","CONNECTED","The recruitment's inclusion criteria will select patients:\n\n* Aged ≥ 65 years\n* Undergoing elective surgical procedures, scheduled to last longer than one hour.\n* Under general anaesthesia, including the procedures using mechanical ventilation, total intravenous anaesthesia (TIVA) or balanced anaesthesia.\n* Planned inpatient length of stay in the hospital ≥ 2 days\n* With and without preoperative exposure to the following neurotoxic viruses: SARS-CoV-2 (COVID-19), Herpes simplex virus (HS), Cytomegalovirus (CMV), and Epstein Barr virus (EBV).\n\nExclusion Criteria:\n\n* Patients aged less than 65 years old.\n* Undergoing non elective surgical procedures.\n* Undergoing surgical procedures lasting less than one hour.\n* Undergoing surgical procedures entailing the impairment of the verbal production, such as brain surgery, maxillofacial surgery and otorhinolaryngology operations. The surgical procedures excluded are the ones affecting the speech and cognitive functions and the surgeries with specific risks of postoperative cognitive impairment (such as cardiac surgery and carotid surgery).\n* Undergoing surgical procedures implying local anaesthesia.\n* Undergoing surgical procedures that do not imply the insertion of an airway device (such as endotracheal tube or laryngeal mask) or the protracted mechanical ventilation.\n* Undergoing surgery procedures with planned mechanical ventilation after surgery \u002F re-intubation.\n* Patients with language barriers.\n* Patients under legal guardianship and with pre-existing cognitive dysfunction (MoCA \\\u003C 21 points).\n* Patients not giving the informed consent.","65 Years",{"count":86,"type":20},1685,"In the last two decades, viral infections have increased dramatically : the 2003 severe acute respiratory syndrome coronavirus outbreak, the 2009 swine flu pandemic, the 2012 Middle East respiratory syndrome coronavirus outbreak, the 2013-2016 Ebola virus disease epidemic in West Africa and the 2015 Zika virus disease epidemic and not least the COVID-19 pandemic.\n\nAt the same time, neurological disorders are a major and increasing global health challenge, which accounts for a substantial portion of the disease burden worldwide . In Europe, more than half of the population (approx. 60% ) suffers from a neurological disease, ranking number three among all disease groups . The figures are higher in the population with more than 65 years.\n\nBased on Eurostat annual publication \"Aging Europe\", in 2020 people over 65 represented 20.6% of the European Union population, and the projections show that the share of people over 65 is expected to strongly increase until 2058, reaching 30.3% of the EU population.\n\nFurthermore, while in civil aviation, the mortality rate is estimated around 0,00525% (Eurocontrol, 2022), the perioperative mortality rate in Europe is about 4% (Pearse et al., 2012). Clearly, the patients undergoing surgery already have a higher mortality risk depending on their initial medical conditions. However, the medical field can without doubts benefit from an improved risks assessment approach derived from the civil aviation.\n\nAgainst this backdrop, the project aims at:\n\ni) researching the correlation between a neurotoxic viruses' infection and the increased risk, in terms of frequency or severity, of developing a cognitive disfunction such as the postoperative cognitive dysfunction (POCD), by conducting an observational clinical trial on selected neurotoxic viruses (SARS-CoV-2, Herpes simplex virus, Cytomegalovirus and Epstein Barr virus).\n\nii) developing a theoretical model for monitoring the implications of general anaesthesia in elder patients aged ≥ 65 years iii) designing a risk assessment mechanism, based on the best practices developed in the aerospace sector, for patients with neurotoxic infection and POCD, that can be furtherly scalable in other medical contexts.\n\niv) building an AI-based platform, following the example of the NSQIP risk calculator for cardiovascular postoperative complications, both for data collection and data processing, able to return an estimate of the risk of perioperative-related cognitive complications in elder patients undergoing major elective surgeries.\n\nObservational Clinical Trial The clinical trial will recruit a sample of 1685 patients in eight centres (about 250 patients per centre, considering also the drop-out rate) to be finalised in 24 months.\n\nThe primary end point of the clinical trial is to evaluate if patients undergoing general anaesthesia for elective major surgeries lasting longer than 1 hour that have an history of COVID-19 (not an active SARS-CoV-2 infection) do have a higher risk to develop postoperative cognitive dysfunction (POCD)\u002Fdelayed neurocognitive recovery (DNC) at 3 months and 6 months follow up after surgery.\n\nSecondary end point include:\n\n1. \\- Relationship between POCD\u002FDNC with preoperative exposure to other neurotropic viruses: Herpes simplex virus (HS), Cytomegalovirus (CMV), and Epstein Barr virus (EBV).\n2. \\- Development -on the basis of collected data- of a software dedicated to calculating in the preoperative phase the risk for early postoperative delirium or POCD\u002FPNDs.\n3. \\- Development of a conceptual model of \"perioperative safety management\": as in civil aviation traffic control, increasing the patients' perception of healthcare safety and quality.\n4. \\- Delivery of training to healthcare practitioners concerning the preoperative evaluation of POD risk and the identification of patients at risk.",[27],"2023-03-28",{"date":91,"type":36},"2023-04-10",{"date":93,"type":20},"2024-03-01",{"date":95,"type":20},"2027-06-01",{"name":97,"class":43},"University of Roma La Sapienza"]