[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sedation-complication\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sedation-complication":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,44,77,108,142,171,196,220,249],{"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":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100517176","phase-2-volatile-sedation-for-patients-with-the-acute-respiratory-distress-syndrome-100517176",false,"NCT06014138","Volatile Sedation for Patients With the Acute Respiratory Distress Syndrome","Effect of Volatile Sedation on Spontaneous Breathing During Mechanical Ventilation for Patients With the Acute Respiratory Distress Syndrome","ISO-DRIVE","Inclusion Criteria:\n\n* Adult patients admitted to the Intensive Care Unit (ICU)\n* ARDS\n* Invasive mechanical ventilation (IMV)\n* Spontaneous breathing in pressures support mode (PSV) for less than or equal to 48 hours\n* Sedated with intravenous sedation (ie. propofol and \u002F or midazolam and fentanyl or alternate short acting opioid)\n* Anticipated to remain on IMV and PSV and with a stable sedation score for a further 24 hours without planned sedation interruption \u002F spontaneous breathing trial or other significant change in the level of ventilator support\n* Not receiving \u002F anticipated to receive paralysis\n* In supine position\n\nExclusion Criteria:\n\n* Personal or family history of malignant hyperpyrexia\n* Known or suspected elevated intracranial pressure\n* High dose vasopressors (ie. Noradrenaline \\> 0.3mcg\u002Fkg\u002Fmin or equivalent)\n* Contra-indication to oesophageal balloon (i.e. oesophageal \u002F upper gastro-intestinal pathology)\n* Pregnancy\n* High dose oral sedatives (e.g. benzodiazepines) or opioids (e.g. oxycodone \u002F oral morphine) which may affect respiratory drive","ALL","17 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","This study will investigate how different types of routine sedation may affect patient's breathing whilst on a ventilator in the Intensive Care Unit (ICU). There are different approaches to sedation which may have advantages and disadvantages. During the study patients will receive both intravenous and inhaled volatile sedation (similar to anaesthetic 'gases' used for general anaesthesia) and the drive to breath, breathing efforts and function of the lung will be assessed.",[28,29,30],"Acute Respiratory Distress Syndrome","Mechanical Ventilation Complication","Sedation Complication","RECRUITING","2026-06-03",{"date":34,"type":35},"2026-06-04","ACTUAL",{"date":37,"type":35},"2023-11-01",{"date":39,"type":21},"2027-07-31",{"name":41,"class":42},"Guy's and St Thomas' NHS Foundation Trust","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":43},"100628013","phase-4-a-comparison-of-remimazolam-besylate-and-propofol-sedation-in-patients-undergoing-colonoscopic-polypectomy-100628013","NCT07456111","A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy","Bypro","Inclusion Criteria:\n\n* Patients both male and female\n* ages 18 to 60 years,\n* with one or more colonic polyps confirmed by colonoscopy and scheduled for a colonoscopy and polypectomy\n* The duration of the colonoscopy ranges from 30 to 50 minutes.\n* ASA status (American Society of Anaesthesiologists physical status) I-III.\n* BMI (Body mass index) 18.5-29.9 kg\u002Fm2.\n* Only patients who signed an informed consent waiver and consented to participate in the research study.\n\nExclusion Criteria:\n\n* Patients aged \\>60 years\n* ASA status IV-V,\n* BMI \\>29.9 kg\u002Fm2,\n* a high risk of vomiting, regurgitation and\u002For aspiration of gastric contents.\n* Patients with:\n* uncontrolled hypertension (systolic pressure \\>160 mmHg),\n* heart disease (cardiomyopathy, cardiac-rhythm disorder, left ventricular ejection fraction \\\u003C45%, stenosis or heart valve insufficiency and coronary heart disease)\n* lung disease (pneumonia, chronic obstructive pulmonary disease, asthma and pulmonary tumors),\n* kidney diseases (kidney failure, GF 30\u002F59 ml\u002Fmin\u002F1.73m2),\n* liver diseases,\n* coagulation disorders\n* lymphatic tissue diseases\n* extended malignant disease.\n* History of allergy on nutritional allergens including soy bean, benzodiazepines, propofol or opioids.\n* Patients who currently use analgesic medications or other psycho-pharmaceuticals.\n* History of illicit drug use.\n* Children, pregnant and nursing women.\n* Alcohol dependency.\n* Patients involved in other clinical research studies,\n* patients who refused to take part in the research or have not signed the written informed consent form.","18 Years","60 Years",{"count":54,"type":21},90,[56],"PHASE4","The goal of this prospective, randomized, controlled study is to compare remimazolam besilat\u002Fsufentanyl and propofol\u002Fsufentanyl in patients during colonoscopic polypectomies procedures.\n\nPatients undergoing colonoscopic polypectomies in procedural sedation using remimazolam besylate\u002Fsufentanyl are circulatory and respiratory as or more stable when compared with propofol\u002Fsufentanyl sedation.",[59,30],"Colonic Polyp",[61,62,63,64,65,66,67],"Remimazolam besylate","Propofol","Procedural sedation","Polypectomy","Circulatory stability","Respiratory stability","Respiratory depression","2026-03-03",{"date":70,"type":35},"2026-03-06",{"date":72,"type":35},"2025-01-01",{"date":74,"type":21},"2028-12-30",{"name":76,"class":42},"Clinical Hospital Centre Zagreb",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100467831","pharmacokinetics-pharmacodynamics-of-morphine-with-or-without-midazolam-administered-by-continuous-infusion-in-neonatal-intensive-care-100467831","NCT05371886","Pharmacokinetics-pharmacodynamics of Morphine With or Without Midazolam Administered by Continuous Infusion in Neonatal Intensive Care","Inclusion Criteria:\n\n* Neonates \\\u003C 45 weeks of corrected gestational age\n* Hospitalized in a Neonatal Intensive Care Unit\n* Undergoing mechanical ventilation\n* Patients that receive morphine alone or morphine and midazolam as continuous infusion\n* Affiliated to a social security system\n\nExclusion Criteria:\n\n* Current weight \\\u003C 600g\n* Neonates under palliative care\n* Therapeutic hypothermia for perinatal anoxia\n* Neonates who underwent a surgical procedure during the past 72 hours\n* Neonates receiving concomitantly a paralytic or another drug for sedation or analgesia other than morphine or midazolam (except for paracetamol\u002Facetaminophen)\n* Parents refusing that their child participate","20 Weeks","45 Weeks",{"count":86,"type":21},180,[88],"NA","This study aims to describe a dose-effect relationship of morphine alone and morphine and midazolam administered as continuous infusion in neonates hospitalized in Neonatal intensive care unit and undergoing mechanical ventilation, through PKPD modelling.",[30,91],"Mechanical Ventilation in Neonates",[93,94,95,96,97],"morphine, midazolam","pharmacokinetics","pharmacodynamics","analgesia","neonates","2025-11-14",{"date":100,"type":35},"2025-11-17",{"date":102,"type":35},"2023-04-01",{"date":104,"type":21},"2027-05-01",{"name":106,"class":42},"Centre Hospitalier Intercommunal Creteil",5,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":127,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":43},"100424030","phase-3-goal-directed-sedation-in-mechanically-ventilated-infants-and-children-100424030","NCT04801589","Goal-Directed Sedation in Mechanically Ventilated Infants and Children","Maximizing Efficacy of Goal-Directed Sedation to Reduce Neurological Dysfunction in Mechanically Ventilated Infants and Children Study","mini-MENDS","Inclusion Criteria:\n\n* Patients will be eligible for enrollment if they are 1) aged 44 weeks post-menstrual age and up to 11 years, 2) planned admission to the pediatric ICU at Monroe Carell Jr. Children's Hospital at Vanderbilt (MCJCHV), and 3) requiring mechanical ventilation (MV) and sedation. Pre-pubescent children (\\\u003C11 years) are typically different from older children who often behave physiologically more similar to adults. Pre-pubescent children are more likely to be admitted to the PICU and are undergoing a steeper curve of neurocognitive maturation. Therefore, these patients may be at greatest risk for worse brain dysfunction.\n\nExclusion Criteria: Patients will be excluded (i.e., not approached for consent) if any one is present:\n\n1. Receiving continuous sedation for \\> 72 hours prior to screening.\n2. Rapidly resolving respiratory failure at screening, with planned immediate liberation from MV.\n3. Severe developmental delay at baseline defined as a score of ≥ 4 (severe disability) on the Pediatric Cerebral Performance Category (PCPC) Scale, referencing cognitive status prior to critical illness.\n4. Clinically significant 2nd or 3rd degree heart block or bradycardia \\\u003C 60 beats per minute.\n5. Benzodiazepine dependency with ongoing medical requirement of continuous benzodiazepine (infusion).\n6. Inability to co-enroll with another study.\n7. Expected death or care plan for withdrawal of support measures within 24 hours of enrollment.\n8. Bilateral vision loss.\n9. Deafness that will preclude delirium evaluation.\n10. Inability to understand English that will preclude delirium evaluation. The inability to understand English in verbal participants will not result in exclusion when the research staff is proficient and\u002For translation services are actively available in that particular language.\n11. Documented allergy to either dexmedetomidine or midazolam.\n12. Medical requirement of continuous (infusion) neuromuscular blockade administration that is planned ongoing for at least 48 hours at time of screening.\n13. Inability to start the informed consent process within the 72 hours from the time that all inclusion criteria were met (possible reasons):\n\n    1. Attending physician refusal\n    2. 72-hour period of eligibility was exceeded before the patient was enrolled\n    3. Legal Authorized Decision Maker (e.g. legal guardian\u002Fpower of attorney) refusal\n    4. Legal Authorized Decision Maker (e.g. legal guardian\u002Fpower of attorney) unavailable\n    5. Legal Authorized Decision Maker (e.g. legal guardian\u002Fpower of attorney) is non-English speaking and available research staff is not proficient and\u002For translation services are not available in that particular language.\n14. Adjusted dosing weight is \\> 50 kg at time of screening.","44 Weeks","11 Years",{"count":119,"type":21},372,[25],"Ventilated pediatric patients are frequently over-sedated and the majority suffer from delirium, a form of acute brain dysfunction that is an independent predictor of increased risk of dying, length of stay, and costs. Universally prescribed sedative medications-the GABA-ergic benzodiazepines-worsen this brain organ dysfunction and independently prolong duration of ventilation and ICU stay, and the available alternative sedation regimen using dexmedetomidine, an alpha-2 agonist, has been shown to be superior to benzodiazepines in adults, and may mechanistically impact outcomes through positive effects on innate immunity, bacterial clearance, apoptosis, cognition and delirium. The mini-MENDS trial will compare dexmedetomidine and midazolam, and determine the best sedative medication to reduce delirium and improve duration of ventilation, and functional, psychiatric, and cognitive recovery in our most vulnerable patients-survivors of pediatric critical illness.",[123,124,30,125,126],"Delirium","Critical Illness","Executive Dysfunction","Post Traumatic Stress Disorder",[128,129,130,131,132],"pediatrics","critical care","agitation","sedation","delirium","2025-09-23",{"date":135,"type":35},"2025-09-29",{"date":137,"type":35},"2021-05-10",{"date":139,"type":21},"2026-09-16",{"name":141,"class":42},"Vanderbilt University Medical Center",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":150,"targetDuration":152,"studyType":153,"phases":4,"briefSummary":154,"conditions":155,"keywords":156,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":170},"100567413","multiparameter-monitoring-system-for-sedation-inthe-icu-100567413","NCT06667869","multipaRameter mOnitoring systeM for sedAtion iNThe ICu","Sistema de monitorización multiparámetros Para sedación de Pacientes críticos en UCI (ROMANTIC: multipaRameter mOnitoring systeM for sedAtion iNThe ICu)","ROMANTIC","Inclusion Criteria:\n\n* Patients admitted to adult critical care units\n* Individuals over 18 years old\n* Requiring sedation for more than 24 hours\n* Patients needing mechanical ventilation for more than 24 hours\n\nExclusion Criteria:\n\n* Patients with neurological pathology as the cause of mechanical ventilation (including recovered cardiocirculatory arrest, fulminant liver failure, and neurocritical conditions, except subdural hematomas or subarachnoid hemorrhages).\n* Pregnancy\n* Presence of psychiatric or intellectual disability prior to hospitalization\n* Drug dependency\n* History of chronic liver damage with hepatic encephalopathy\n* Second period of mechanical ventilation during hospitalization\n* Early limitation of therapeutic effort\n* Patients under 18 years old",{"count":151,"type":21},80,"2 Weeks","OBSERVATIONAL","The administration of sedation in Intensive Care Units (ICU) is a vital and complex task, essential for the well-being of critically ill patients. Proper dosing is crucial, as both under-dosing and overdosing have adverse consequences for patients, including risks such as accidental extubation, ventilator disconnections, delirium, prolonged ventilation, ICU stays, and even increased mortality.\n\nMonitoring sedation levels is essential to maintain a balance in sedative administration. Clinical scales (RASS\u002FSAS) are currently used as the reference method, but they have limitations. These scales may be inadequate when the patient is unresponsive or when neuromuscular blockers are used. An alternative is electroencephalography (EEG)-based monitors, though they also have limitations in accurately representing the level of hypnosis.\n\nThe proposal is to develop an advanced multiparameter system called ROMANTIC, which utilizes machine learning algorithms to monitor sedation status continuously. The aim is for this system to surpass current techniques and provide a more accurate determination of sedation levels. ROMANTIC would incorporate a variety of variables, demographic, pharmacological, hemodynamic, respiratory, and EEG data, to predict sedation status in three categories: under-dosing, appropriate dosing, and overdosing.\n\nWith ROMANTIC, clinical staff (users) are expected to be able to determine sedation levels more quickly and accurately, reducing patients' wake-up times and possibly decreasing the incidence of delirium. In the long term, this could result in fewer ICU bed days, less time on mechanical ventilation, cost savings, and reduced complications.\n\nAt the end of the project, the goal is to have a prototype model or software that allows non-specialized staff (users) to quickly determine sedation levels in the ICU. This machine learning-based model targets hospitals with ICUs and mechanical ventilation to offer more efficient and cost-effective clinical care. ROMANTIC seeks to innovate in sedation monitoring, providing a more advanced and precise tool for the care of critically ill patients (beneficiaries) in the ICU.",[30],[157,158,123,159,160],"Intensive Care Unit","Machine Learning","Mechanical ventilation","Monitoring","2025-06-04",{"date":163,"type":35},"2025-06-08",{"date":165,"type":35},"2025-02-14",{"date":167,"type":21},"2026-12-15",{"name":169,"class":42},"Pontificia Universidad Catolica de Chile",2,{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":178,"minAge":179,"maxAge":51,"enrollmentInfo":180,"targetDuration":4,"studyType":153,"phases":4,"briefSummary":182,"conditions":183,"keywords":184,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":43},"100513746","validation-of-a-processed-eeg-device-for-monitoring-sedation-in-picu-100513746","NCT05969483","Validation of a Processed EEG Device for Monitoring Sedation in PICU","Validation of a Processed EEG Device (pEEG, Masimo Sedline®) as a Monitoring Tool for the Analgosedation Level in Mechanically Ventilated Critically Ill Children","Inclusion Criteria:\n\n\\- sedated and ventilated patients admitted in PICU\n\nExclusion Criteria:\n\n* skin lesions\n* significant traumatic lesions in the area where the Masimo Sedline® sensor need to be applied.","FEMALE","1 Day",{"count":181,"type":21},150,"The goal of this prospective observational study is to validate pEEG as a monitoring tool for the analgosedation level in mechanically-ventilated critically ill children, receiving or not-receiving NMBAs. The main question aims to answer is to measure the strength of agreement between pEEG score and Comfort Behavioural Scale (CBS) (goal standard).\n\nParticipants will be monitored with pEEG and CBS evaluated during PICU admission. paralysis holiday) by a specialized PICU nurse and by a critical-care expert physician, blinded to each other.",[30],[131,185,186],"pediatric intensive care","monitoring","2025-01-27",{"date":189,"type":35},"2025-01-28",{"date":191,"type":35},"2022-10-01",{"date":193,"type":21},"2025-03",{"name":195,"class":42},"Azienda Ospedaliera di Padova",{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":22,"phases":207,"briefSummary":208,"conditions":209,"keywords":210,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":218,"locationsCount":170},"100575209","effect-of-goal-directed-analgesia-and-sedation-using-eeg-derived-qconqnox-in-icu-patients-100575209","NCT06769308","Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON\u002FqNOX in ICU Patients","Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON\u002FqNOX in ICU Patients Undergoing Mechanical Ventilation: a Randomized Controlled Trial","SED_ICU","Inclusion Criteria:\n\nAge 18-90 years Admission to the ICU for less than 24 hours Expected mechanical ventilation for \\>48 hours Ongoing sedation\n\nExclusion Criteria:\n\nMechanical ventilation (MV) for less than 48 hours Patient or next of kin refusal to participate BMI \\> 35 Cerebrovascular disease Scheduled surgery Neuromuscular disease Presence of craniofacial trauma that prevents the placement of electrodes","90 Years",{"count":206,"type":21},174,[88],"Sedation and analgesia are fundamental tools for managing critical patients who require mechanical ventilation. However, recent scientific literature highlights that excessive sedation in these patients can increase the duration of mechanical ventilation and extend the overall length of stay in intensive care, as well as expose them to a higher risk of hypotension, venous thrombosis, and nosocomial pneumonia. The titration of sedation and analgesia in intensive care, on the other hand, is currently based primarily on clinical parameters (such as the onset of delirium, asynchronies with the ventilator, for example), which can lead to treatments not proportionate to the patient's needs.\n\nThe present study aims to evaluate the application, in an intensive care setting, of the Conox® system, a device already widely used in monitoring the anesthetic plan in the operating room. This tool would allow, through the processing of an EEG trace, the assessment of the level of sedation (qCON) and the probable algic response (qNOX), thus providing valuable information for the fine-tuning of the analgo-sedative plan.",[30,29],[211],"ICU, sedation, analgesia, mechanical ventilation","2025-01-09",{"date":214,"type":35},"2025-01-10",{"date":216,"type":35},"2024-01-01",{"date":39,"type":21},{"name":219,"class":42},"Università degli Studi di Ferrara",{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":22,"phases":228,"briefSummary":229,"conditions":230,"keywords":234,"overallStatus":239,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":43},"100551367","position-intervention-to-reduce-hypoxemia-in-sedation-patients-100551367","NCT06459167","Position Intervention to Reduce Hypoxemia in Sedation Patients","Inclusion Criteria:\n\n1. Patients with 18 years or older\n2. Without obvious cardiovascular or pulmonary dysfunction\n3. Scheduled to undergo procedure or surgery with sedation\n4. Signed the informed consent form\n\nExclusion Criteria:\n\n1. Preexisting bradycardia (heart rate \\\u003C50 beats\u002Fmin), hypotension (systolic blood pressure \\\u003C 80mmHg), or hypoxemia (SpO2 \\\u003C 90%);\n2. Requiring supplemental chronic or intermittent oxygen therapy because of preexisting diseases\n3. Preexisting diseases which unable to tolerate reduced SpO2 or Partial pressure of carbon dioxide in artery (PaCO2) diseases, such as severe cardiovascular and cerebrovascular diseases, intracranial hypertension or severe lung diseases;\n4. Coagulation disorders or a tendency of nose bleeding;\n5. Patients whose body position cannot be altered;\n6. Participated in other intervention clinical studies in the past 3 months;\n7. Other conditions deemed unsuitable for inclusion by the researcher;\n8. Patients and guardians refused to participate in this trial.",{"count":227,"type":21},1752,[88],"Hypoxemia was defined as an SpO2 of \\\u003C 90% for any duration. Failure to treat promptly can lead to hypoxemia, which may increase the risks of arrhythmia, nausea and vomiting, and cognitive dysfunction. Studies have shown that body position has a direct impact on respiratory function. In special environments, including outside the operating room where emergency airway management for critically ill and injured patients is needed, or in areas with limited medical resources like remote areas, adopting simple interventions by changing position to maintain patients' respiratory function can be more economical, convenient and safe.",[231,30,232,233],"Hypoxemia","Emergencies","Airway Remodeling",[235,236,131,237,238],"position","hypoxemia","emergency","upper airway","NOT_YET_RECRUITING","2024-06-10",{"date":242,"type":35},"2024-06-14",{"date":244,"type":21},"2024-06-20",{"date":246,"type":21},"2026-06-30",{"name":248,"class":42},"First Affiliated Hospital of Zhejiang University",{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":257,"sex":17,"minAge":51,"maxAge":258,"enrollmentInfo":259,"targetDuration":261,"studyType":153,"phases":4,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":43},"100498046","safe-brain-initiative-operationalizing-precision-anaesthesia-100498046","NCT05765162","Safe Brain Initiative, Operationalizing Precision Anaesthesia","Safe Brain Initiative - Dedicated to Advancing Anaesthesia and Perioperative Personalised Care Towards Precision Anaesthesia Care. A Continuous Quality Improvement Initiative.","SBI","Inclusion Criteria:\n\n• All patients from age ≥18\n\nExclusion Criteria:\n\n• All patients from age \\\u003C18",true,"100 Years",{"count":260,"type":21},15000,"5 Years","Perioperatively, patients experience an unnecessarily high level of side effects associated with their treatment. These side effects include nausea, severe pain, anxiety, and stress. Moreover, many patients develop postoperative delirium (POD) and neurocognitive dysfunctions, often resulting in long-term cognitive impairment, decreased quality of life, and increased mortality. However, physicians, nurses and their institutions do not receive structured feedback regarding these aspects of each patient's well-being. They may therefore be unable to engage in the essential cause-and-effect learning necessary to evaluate and consecutively reduce such side effects.\n\nEffective guidelines conform prevention is the proven key to shielding our patients from adverse Outcomes. The Safe Brain Initiative's high-quality routine data-for-action is a sword and accelerator for moving towards patient-centred, precision care. Thus, establishing a foundation for value-based and patient-centred healthcare development.\n\nHowever, a turnkey real-world solution is challenging to develop and implement and requires substantial resources. As a result, such solutions are usually beyond the scope of a single institution. The SBI platform provides high-quality, real-world data to bridge this gap. It allows monitoring and in-depth analysis of cause and effect in the day-to-day routine of individuals, departments, and institutions.\n\nThe SBI's approach is continuously improved and updated. An organization called the SBI Global Society oversees the quality and precision of science through experts in the field. At SBI Hospitals and Flagship centres, Masterclasses are conducted and can be attended alongside clinical immersions.\n\nSBI Solutions manages, develops, and provides technical and service support for the Safe Brain Initiative. Its service guarantees the professional and GDPR conform management of data handling and storage as well as the user-friendly functionality of the SBI-Dashboard solutions.",[264,265,266,267,268,269,270,271,272,273,30,274,275,276,277,278,279],"Neurocognitive Disorders","Post Operative Delirium","Pain","Nausea","Vomiting","Wellbeing","Shivering","Anxiety","Stress","Agitation,Psychomotor","Thirst","Satisfaction, Patient","Temperature Change, Body","Fasting","Sore-throat","Hearing and Vision Loss","2024-06-05",{"date":282,"type":35},"2024-06-07",{"date":284,"type":35},"2021-12-01",{"date":286,"type":21},"2026-01-01",{"name":288,"class":42},"University of Southern Denmark"]