[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intensive-care-unit-icu-patients\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intensive-care-unit-icu-patients":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,44,78,102,127,160],{"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":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100602873","pulmonary-microbiota-changes-and-clinical-outcomes-in-neurosurgical-icu-patients-with-artificial-airways-100602873",false,"NCT07129174","Pulmonary Microbiota Changes and Clinical Outcomes in Neurosurgical ICU Patients With Artificial Airways","Association Between Changes in Pulmonary Microbiota and Clinical Outcomes in Neurosurgical ICU Patients With Artificial Airways: A Prospective Observational Cohort Study","Inclusion Criteria:\n\n* Patients must meet all of the following conditions to be eligible for inclusion:\n\n  1. First admission to the Intensive Care Unit (ICU).\n  2. Assessed by an ICU specialist as expected to require artificial airway support (e.g., mechanical ventilation) for more than 24 hours.\n  3. Neurosurgical patients. Postoperative neurosurgical patients are defined in this study as those who have undergone surgery for: brain tumors, Subarachnoid hemorrhage, Traumatic brain injury\n\nExclusion Criteria:\n\n* Patients meeting any of the following criteria will be excluded:\n\n  1. Age under 18 years\n  2. Pregnancy\n  3. Pre-existing spinal cord injury\n  4. History of chronic pulmonary diseases, including: Chronic bronchitis, Chronic obstructive pulmonary disease (COPD), Bronchial asthma, Bronchiectasis, Interstitial lung disease, Pleural effusion\n  5. Pre-existing immunosuppressive conditions, including: Systemic immunomodulatory therapy, Chemotherapy, HIV infection, Other congenital or acquired immunodeficiency disorders\n  6. Receipt of systemic antimicrobial therapy within the past 3 months\n  7. Diagnosis of primary lung cancer or lung metastases from other tumors\n  8. History of partial lung resection for any reason","ALL","18 Years",{"count":19,"type":20},220,"ESTIMATED","28 Days","OBSERVATIONAL","After neurosurgery, many patients need to stay in the intensive care unit (ICU) and use a breathing machine (mechanical ventilation) because of issues like decreased consciousness, weak breathing, or poor airway protection. During this period, the natural balance of bacteria in the lungs-known as the lung microbiota-can be disturbed by surgery, antibiotics, and airway procedures. This may reduce healthy bacteria and allow harmful bacteria to grow, increasing the risk of lung infections such as ventilator-associated pneumonia (VAP).\n\nThis study will follow 220 postoperative neurosurgical ICU patients at three centers: Beijing Tiantan Hospital, Beijing Shijitan Hospital, and Beijing Anzhen Hospital from August 2025 to August 2026. These patients will include those undergoing surgery for brain tumors, brain hemorrhage, or traumatic brain injury. Airway secretion samples (tracheal aspirates) will be collected shortly after surgery and at several subsequent time points to assess how lung bacteria change over time while patients are using a breathing machine.\n\nUsing advanced laboratory methods, the investigators will measure both the amount and types of bacteria in the lungs. The aim is to determine how these changes are related to patient outcomes, such as the occurrence of lung infections.\n\nThe results of this study may contribute to earlier detection of lung infections and the development of personalized treatment plans to improve recovery in ICU patients after neurosurgery.",[25,26,27],"Ventilator-Associated Pneumonia (VAP)","Intensive Care Unit (ICU) Patients","Microbiome Dysbiosis",[25,29,30],"Intensive care unit (ICU)","Pulmonary Microbiota","RECRUITING","2026-05-19",{"date":34,"type":35},"2026-05-22","ACTUAL",{"date":37,"type":35},"2025-08-30",{"date":39,"type":20},"2026-08-30",{"name":41,"class":42},"Jian-Xin Zhou","OTHER",3,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100626896","evaluation-of-the-clinical-and-prognostic-value-of-non-invasive-analysis-of-mandibular-movements-mm-as-a-marker-of-inspiratory-effort-in-the-spontaneously-breathing-intensive-care-patient-100626896","NCT07441590","Evaluation of the Clinical and Prognostic Value of Non-invasive Analysis of Mandibular Movements (MM) as a Marker of Inspiratory Effort in the Spontaneously Breathing Intensive Care Patient","MM-ICU","Inclusion Criteria:\n\n* Adult patients (≥ 18 years)\n* Admitted to the Intensive Care Unit for acute respiratory failure\n* On invasive mechanical ventilation for more than 24 hours with:\n\n  * A respiratory rate ≤ 35 breaths\u002Fminute;\n  * Adequate oxygenation, defined as either an oxygen saturation of at least 90% (obtained during ventilation with a fraction of inspired oxygen \\[FiO2\\] ≤ 40% and a positive end-expiratory pressure \\[PEEP\\] ≤ 8 cm of water) or an arterial partial pressure of oxygen (PaO2) (measured in mmHg) \u002F FiO2 ratio \\> 150 (obtained during ventilation with a PEEP ≤ 8 cm of water);\n  * Respiratory muscle capacity allowing for an effective cough;\n  * A state of wakefulness, defined as a Richmond Agitation and Sedation Scale (RASS) score of -2 to +1;\n  * No use of continuous sedation;\n  * No use of vasopressors (or use of minimal doses).\n* At high risk of weaning failure defined by at least one of the following criteria (5):\n\n  * Age \\> 65 years\n  * A cardiac comorbidity among: systolic dysfunction (ejection fraction ≤45%), permanent atrial fibrillation, or a history of cardiogenic pulmonary edema or myocardial ischemia\n  * A respiratory comorbidity among: COPD, restrictive lung disease, or obesity hypoventilation syndrome\n* Written informed consent obtained from the patient, or in case of incapacity, from the next of kin\u002Ftrusted person\n* Patient covered by social security\n\nExclusion Criteria:\n\n* Absolute contraindication to NIV (patient refusal, undrained pneumothorax, intractable vomiting, upper airway obstruction, upper gastrointestinal bleeding, severe craniofacial trauma)\n* Absolute contraindication to nasogastric tube placement (upper gastrointestinal bleeding, epistaxis, skull base trauma)\n* Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant woman, parturient woman, breastfeeding mother, person deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8, persons admitted to a health or social establishment for purposes other than research, minors, person subject to a legal protection measure or unable to express their consent).",{"count":52,"type":20},50,"INTERVENTIONAL",[55],"NA","Evaluate the performance for measuring inspiratory effort of non-invasive mandibular movement analysis compared to the reference technique oesophageal pressure (PES) variation, in ventilated and spontaneously breathing Intensive Care Unity (ICU) patients, during weaning from mechanical ventilation and within 48 hours after extubation.\n\nThe investigators hypothesis is that the assessment of respiratory effort by MM analysis could represent a non-invasive and reliable alternative to the measurement of PES in critically ill patients.",[58,26,59],"Acute Respiratory Failure (ARF)","Invasive Mechanical Ventilation",[61,62,63,64,65,66],"intensive care unit","acute respiratory failure","invasive mechanical ventilation","weaning from mechanical ventilation","ventilatory control","Breathing efforts","NOT_YET_RECRUITING","2026-02-23",{"date":70,"type":35},"2026-03-02",{"date":72,"type":20},"2026-02",{"date":74,"type":20},"2027-04",{"name":76,"class":42},"University Hospital, Grenoble",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":88,"studyType":22,"phases":4,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100621664","post-intensive-care-syndrome-and-associated-symptom-burden-among-danish-icu-survivors-100621664","NCT07373561","Post-Intensive Care Syndrome and Associated Symptom Burden Among Danish ICU Survivors","Post-Intensive Care Syndrome and Associated Symptom Burden Among Danish ICU Survivors: An Inception Cohort Study (PICAS-DK)","PICAS-DK","Inclusion Criteria:\n\n* Adult patients ≥ 18 years of age\n* Admitted to the intensive care unit for ≥48 hours\n* Acutely admitted to the intensive care unit\n\nExclusion Criteria:\n\n* Patients with limited treatment\n* Foreign patients\n* Pregnant women\n* Patient with impaired cognitive function (e.g. dementia, intellectual disability)\n* Patient without Danish citizenship\n* Patient with limited proficiency in the Danish language",{"count":87,"type":20},800,"12 Months","The study aims to estimate the prevalence of post-intensive care syndrome (PICS) 12 months after ICU admission among adult ICU survivors in Denmark and to describe how this prevalence is distributed across the physical, cognitive, and mental health domains. By conducting follow-up assessments at 3, 6, and 12 months post-discharge, the study further seeks to determine the prevalence of PICS at each time point, characterise its temporal trajectory, and explore patients' symptom burden over time.\n\nResearch question\n\n* What is the prevalence of PICS and its specific components (physical, cognitive, and mental health domains) among ICU survivors 12 months after ICU admission?\n* How do the components of PICS evolve during the follow-up period (trajectory)?\n* What risk factors are associated with the development of PICS in ICU survivors?\n* Are there differences in PICS prevalence based on demographic or clinical characteristics (e.g., age, comorbidities, ICU length of stay)?\n\nThe hypothesis is that the prevalence of post-intensive care syndrome (PICS) in a Danish cohort of adult ICU survivors at 12 months will be approximately one third, defined as impairment in at least one of the three PICS domains (physical, cognitive, or mental health), measured using validated instruments with pre-specified cut-offs.",[91,92,26],"Post-Intensive Care Syndrome (PICS)","Symptom Burden","2026-01-28",{"date":95,"type":35},"2026-01-30",{"date":97,"type":20},"2026-06-01",{"date":99,"type":20},"2028-09-30",{"name":101,"class":42},"Zealand University Hospital",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":53,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":77},"100605211","pets-enhancing-therapeutics-in-intensive-care-units-100605211","NCT07159568","Pets Enhancing Therapeutics in Intensive Care Units","Visits by Pet Dogs to Patients Admitted to Intensive Care at the Clermont-Ferrand University Hospital: Feasibility Study","PET-ICU","Inclusion Criteria:\n\n* Adult patient aged 18 years or older,\n* Admitted to one of the participating ICUs at Clermont-Ferrand University Hospital (Estaing Adult ICU, Montpied Medical-Surgical ICU, or Montpied Neuro-ICU) with an expected ICU stay of 48 hours or more,\n* Owner of a companion dog, with family members or relatives able to bring the dog to the ICU.\n\nExclusion Criteria:\n\nPatient-related exclusion criteria:\n\n* Refusal by the patient or by their family\u002Frelatives to participate,\n* Lack of affiliation with the French national health insurance system (Sécurité Sociale),\n* Patient deprived of liberty or under legal protection (guardianship, curatorship, or judicial safeguard),\n* Pregnant or breastfeeding patient,\n* Agitated patient, defined as a Richmond Agitation-Sedation Scale (RASS) score \\> 0 (monitored every four hours according to current standard practice),\n* Patient with immunosuppression, defined as: blood neutrophil count \\\u003C 0.5 G\u002FL, ongoing or recent (within the past month) treatment for solid or hematologic cancer (e.g., chemotherapy, radiotherapy, cell therapy), or receiving immunosuppressive drugs (including organ transplant recipients or corticosteroid therapy for more than two weeks),\n* Patient with known colonization by multidrug-resistant bacteria (as routinely assessed upon ICU admission and weekly thereafter),\n* Patient with one or more open wounds or injuries that cannot be covered with a dressing.\n\nDog-related exclusion criteria:\n\n* Dog belonging to category 1 or 2 breeds considered dangerous under current French regulations,\n* Dog that never leaves the home environment,\n* Dog with an incomplete vaccination status,\n* Dog with a known transmissible disease.",{"count":111,"type":20},21,[55],"Intensive Care Units (ICUs) are well known for their therapeutic and environmental aggressiveness. Current recommendations for the management of critically ill patients, including the \"ABCDEF bundle,\" emphasize family engagement and liberal visitation policies for relatives and loved ones, with the aim of improving patient well-being during their ICU stay.\n\nIn France, half of all households own a pet. This close relationship between humans and animals explains why animals have long been involved in medical care. The earliest known use of animals in medicine dates back to the 9th century in Belgium, where they were used to assist individuals with mental illness. More recently, companion animal-assisted interventions have attracted growing interest due to their potential diagnostic and\u002For therapeutic value, as they may enhance the patient experience during hospitalization. The feasibility, safety, and potential benefits of pet visitation policies have mainly been assessed in conventional hospital wards, but remain understudied in the ICU setting. In France, to our knowledge, only three hospitals have allowed pet visits in the ICU, and these occurred outside of any research protocol.\n\nThe study primary objective is to assess the feasibility of companion dog visits in three medical-surgical ICUs.",[26,115],"Dog Therapy",[117],"dog therapy","2025-09-05",{"date":120,"type":35},"2025-09-08",{"date":122,"type":20},"2025-09-15",{"date":124,"type":20},"2027-10-15",{"name":126,"class":42},"University Hospital, Clermont-Ferrand",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":134,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":137,"conditions":138,"keywords":145,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":77},"100589962","effectiveness-of-ventilation-modes-in-intensive-care-a-comparison-of-mandatory-minute-ventilation-and-synchronized-intermittant-mandatory-ventilation-using-bioelectrical-impedance-tomography-100589962","NCT06961227","Effectiveness of Ventilation Modes in Intensive Care: A Comparison of Mandatory Minute Ventilation and Synchronized Intermittant Mandatory Ventilation Using Bioelectrical Impedance Tomography","Comparative Analysis of Ventilation Distribution in Intensive Care: Mandatory Minute Ventilation Versus Synchronized Intermittent Mandatory Ventilation Using Electrical Impedance Tomography\"","Inclusion Criteria:\n\n* Age ≥ 18 years\n\nIntubated and receiving invasive mechanical ventilation\n\nHemodynamically stable (no vasopressor support)\n\nFiO₂ ≤ 60%\n\nPEEP ≤ 8 cmH₂O\n\nNot receiving neuromuscular blocking agents\n\nAble to tolerate switching between SIMV and MMV modes\n\nExclusion Criteria:\n\nPregnant or breastfeeding patients\n\nPatients with neuromuscular diseases affecting respiratory drive\n\nUnstable hemodynamics or ongoing need for vasopressors\n\nPatients requiring high PEEP (\\>8 cmH₂O)\n\nPatients with DNR (do not resuscitate) status\n\nParticipation in another interventional study\n\n\\-",true,{"count":136,"type":20},25,"Synchronized Intermittent Mandatory Ventilation (SIMV) is a commonly used ventilatory mode available in many modern ventilators, frequently applied in intensive care units for patients requiring invasive mechanical ventilation. SIMV delivers a preset tidal volume or pressure at a predetermined respiratory rate and synchronizes with the patient's spontaneous breathing efforts, thereby enhancing patient-ventilator interaction and contributing to rehabilitation.\n\nMandatory Minute Ventilation (MMV) is a hybrid mode combining features of SIMV and Pressure Support Ventilation (PSV), guaranteeing a preset minute ventilation (tidal volume × respiratory rate). It synchronizes support based on the patient's spontaneous efforts and compensates in cases of insufficient minute ventilation.\n\nElectrical Impedance Tomography (EIT) is a non-invasive, radiation-free imaging technique that enables real-time monitoring of pulmonary ventilation and perfusion by applying alternating electrical currents through surface electrodes. EIT has demonstrated strong correlation with findings from computed tomography, nitrogen washout, PET, and SPECT imaging modalities.\n\nThis study aims to evaluate the effectiveness of MMV compared to SIMV in mechanically ventilated, hemodynamically stable adult patients (\\>18 years old) in the intensive care unit. Patients must not require vasopressors, have a FiO₂ ≤ 60%, PEEP ≤ 8 cmH₂O, or receive neuromuscular blocking agents.\n\nPatients will be monitored under both SIMV and MMV modes, separated by a 12-hour interval. To minimize carry-over effects, a one-hour washout period will be implemented before data collection with EIT. Key parameters including PO₂\u002FFiO₂ ratio, PaCO₂, and EtCO₂ will be assessed. The sequence of ventilatory mode application will follow a crossover study design.",[139,140,141,142,26,143,144],"Ventilation Modes","Mechanical Ventilation","Critical Illness","Respiratory Support","Mechanical Ventilation Dependence","Evaluation of Mechanical Ventilation Modes (SIMV and MMV) in Adult Intensive Care Unit Patients Using Electrical Impedance Tomography",[140,146,147,148,149,150],"SIMV","MMV","Electrical Impedance Tomography","EIT","Intensive Care Unit","2025-04-29",{"date":153,"type":35},"2025-05-07",{"date":155,"type":35},"2025-03-10",{"date":157,"type":20},"2025-10-31",{"name":159,"class":42},"Harran University",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":167,"targetDuration":169,"studyType":22,"phases":4,"briefSummary":170,"conditions":171,"keywords":176,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":214},"100569686","muscle-and-subcutaneous-tissue-variation-by-ultrasound-and-impedance-linked-to-fluid-balance-in-icu-patients-100569686","NCT06697470","Muscle and Subcutaneous Tissue Variation by Ultrasound and Impedance Linked to Fluid Balance in ICU Patients","Cross-sectional Study on the Variation of Muscle Thickness and Subcutaneous Tissues by Ultrasound and Bioelectrical Impedance in Association with the Fluid Balance of Patients in Intensive Care","Inclusion Criteria:\n\n* Adults aged over 18 years.\n* Patients present and admitted to the ICU at Epicura Hornu Hospital between October 14, 2024, and November 15, 2024 (to be updated).\n* Informed consent to participate in the study has been signed by the patient or their legal representative.\n\nExclusion Criteria :\n\n* Patients in post-operative or other surveillance with an expected ICU stay of less than 48 hours.\n* Patients for whom a decision to withdraw therapy has been made prior to inclusion.\n* Presence of skin conditions (e.g., wounds or ulcers) that hinder ultrasound measurements or the application of skin electrodes.\n* Pregnancy.\n* Presence of an implanted pacemaker or defibrillator.",{"count":168,"type":20},40,"5 Days","This cross-sectional study aims to investigate the relationship between variations in muscle thickness and subcutaneous tissue, measured by ultrasound, and fluid compartments, evaluated using bioelectrical impedance analysis (BIA), in critically ill patients in the intensive care unit (ICU). Critically ill patients frequently experience muscle wasting and tissue edema due to a combination of inflammation, immobilization, and aggressive fluid resuscitation protocols designed to counteract hemodynamic instability.\n\nUltrasound is widely used to monitor muscle thickness because it is fast, non-invasive, and repeatable. However, muscle thickness measurements during the first days of ICU admission may be influenced by fluid overload, which causes edema and might lead to an overestimation of actual muscle mass. Bioelectrical impedance analysis (BIA) is a complementary tool that assesses both intra- and extracellular fluid compartments. This study aims to correlate daily fluid balance with changes in muscle thickness and subcutaneous tissue measured by ultrasound, and to determine if BIA can accurately reflect fluid status and potentially identify edema in these patients.\n\nFurthermore, at ICU discharge, patients' muscle strength will be assessed using both the MRC-sum score (0-60) and handgrip strength (using a Jamar dynamometer), to investigate whether the presence of edema at discharge correlates with muscle strength deficits. Data collection will occur daily, tracking fluid balance, clinical parameters, and body weight, alongside ultrasound and BIA measurements in a standardized position. The study will help clarify the interactions between fluid management, muscle mass changes, and clinical outcomes in critically ill patients, providing valuable insight into early rehabilitation strategies.",[172,173,174,175,141,26],"Weakness Acquired in the ICU","Muscle Wasting","Edema","Fluid Overload",[177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204],"Muscle thickness","Subcutaneous tissue","Ultrasound","Bioelectrical impedance analysis","BIA","Fluid balance","ICU (intensive care unit)","Muscle strength","MRC-sum score","Grip strength","Edema assessment","Critical care","Skeletal muscle","Hydration status","Muscle echogenicity","ICU-acquired weakness","Fluid compartments","Extracellular water","Intracellular water","Body composition","Bedside ultrasound","Fluid management","Early mobilization","Volume overload","Tissue edema","Body water compartments","Length of ICU stay","Muscle quality","2024-11-17",{"date":207,"type":35},"2024-11-20",{"date":209,"type":35},"2024-10-21",{"date":211,"type":20},"2024-11-15",{"name":213,"class":42},"Dr F Duprez",2]