[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intensive-care-unit-acquired-weakness\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intensive-care-unit-acquired-weakness":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,45,78,109,130,161,192,218,248,271,294],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100639593","application-of-the-concept-of-proprioceptive-neuromuscular-facilitation-in-trunk-control-in-patients-admitted-to-the-icu-100639593",false,"NCT07584564","Application of the Concept of Proprioceptive Neuromuscular Facilitation in Trunk Control in Patients Admitted to the ICU.","Effects of Applying the Concept of Proprioceptive Neuromuscular Facilitation in Trunk Control in Patients Admitted to the ICU: A Randomized Clinical Trial.","PNF","Inclusion Criteria:\n\n* Over 18 years of age\n* ICU stay greater than or equal 48 hours;\n* RASS scale score greater than or equal to -2 and less than or equal to 1;\n* TCT score less than or equal to 12 points on the \"balance in sitting position\" score less than or equal to 2 on item 3 \"sitting without support\".\n\nExclusion Criteria:\n\n* Patients in a coma, with spinal cord instability, metastases, and bone lesions;\n* Neuromuscular or neurological diseases\n* Discharge from the general ICU before SBL\n* Proportional care phase 3;\n* Readmissions to the general ICU;","ALL","18 Years",{"count":20,"type":21},58,"ESTIMATED","INTERVENTIONAL",[24],"NA","Muscle weakness acquired in the ICU (FAUTI) is related to the functional decline of patients admitted to an Intensive Care Unit (ICU). For better follow-up, scales such as (Chelsea Critical Care Physical Assessment) CPAx and (Medical Research Council) MRC help to identify early the muscle and functional impairment of these patients. Early mobilization aims to minimize these effects and therefore the search to reach the highest mobility milestone is constant bedside sitting (BSS) is an important milestone in recovery, associated with better functional results when there is good trunk control, as the coordinated activation of muscles in this region is essential for stabilization and reaching higher postures. The physiotherapeutic approach focused on the components of the activities and on the patient's participation is crucial, with the therapeutic option of Proprioceptive Neuromuscular Facilitation (PNF). To evaluate the effect of exercises based on the PNF concept through the Test Control Trunk (TCT) on the trunk balance of patients admitted to the ICU. This is a randomized, crossover clinical trial, carried out at the Pedro Ernesto University Hospital from June 2026 to June 2027. Adults hospitalized for more than 48 hours who meet the inclusion criteria will be screened. and clinical evaluation. The study consists of two blocks of pre- and post-crossover evaluations, conducted by the same blind evaluator. Patients will undergo assessments on the first day of BSS, including assessment of the trunk with TCT and assessment of diaphragm mobility and thickness by ultrasound, before and after intervention (PNF or conventional exercises). Between assessments, there will be a 3-hour rest period.",[27],"Intensive Care Unit Acquired Weakness",[29,30,31],"Postural Balance","Proprioceptive Neuromuscular Facilitation","Diaphragm","NOT_YET_RECRUITING","2026-05-18",{"date":35,"type":36},"2026-05-22","ACTUAL",{"date":38,"type":21},"2026-06-01",{"date":40,"type":21},"2028-12-31",{"name":42,"class":43},"Universidade Federal do Rio de Janeiro","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":44},"100460739","locomotor-muscle-oxygenation-and-activation-during-acute-interval-compared-to-constant-load-bed-cycling-exercise-100460739","NCT05279547","Locomotor Muscle Oxygenation and Activation During Acute Interval Compared to Constant-load Bed-cycling Exercise","Locomotor Muscle Oxygenation and Activation During Acute Interval Compared to Constant-load Bed-cycling Exercise: A Pilot Study","Inclusion Criteria:\n\n* Full cooperatively adult patients indicated by the Adequacy Score of standardized 5 questions (SQ5) = 5\u002F5\n* Patients mechanically ventilated for longer than 48 hours during the same ICU admission\n* Patients are expected to remain in the ICU for more than an additional 48 hours starting from study enrollment\n* Patients able to perform active cycling for \\> 10 consecutive minutes\n\nExclusion Criteria:\n\n* Pre-existing functional limitations\n* Low limb injuries or conditions that would preclude in-bed cycling such as a body habitus unable to fit the bike\n* Extreme obesity (body mass index \\>35 kg\u002Fm2)\n* Neurologically unstable\n* Acute surgery\n* Palliative goals of care\n* Temperature \\> 40 °C\n* An anticipated fatal outcome\n* Evidence of coronary ischaemia, for example, chest pain or electrocardiogram changes\n* Resting heart rate \\\u003C40 or \\>120 beats per minute\n* Mean arterial pressure \\\u003C60 or \\>120 mmHg\n* Peripheral capillary oxygen saturation \\\u003C 90%\n* Wounds, trauma or surgery of leg precluding cycle ergometry\n* Wounds, trauma or surgery of pelvis precluding cycle ergometry\n* Wounds, trauma or surgery of lumbar spine precluding cycle ergometry\n* Coagulation disorder (international normalised ratio \\> 1.8, or platelets \\\u003C 50,000 mcL)\n* Intracranial pressure \\>20 mm Hg\n* Femoral access other than femoral central line\n* Acute deep vein thrombosis\n* Pulmonary embolism\n* \\>20 mcg\u002Fmin of noradrenaline\n* inotropic or vasopressor support comparable to a dose of noradrenaline \\>20mcg\u002Fmin\n* Fraction of inspired oxygen \\> 55%\n* Arterial partial pressure of oxygen (PaO2) \\\u003C65 torr (\\\u003C8.66 kPa)\n* Positive end-expiratory pressure \\> 10 cmH2O\n* Respiratory rate \\> 30 breaths per minutes with adequate ventilatory support\n* Minute ventilation \\>150 mL\u002Fkg body weight",{"count":53,"type":21},100,[24],"Up to 60% of patients admitted to the Intensive Care Unit (ICU) with a prolonged stay in the ICU develop complications such as intensive care unit acquired weakness (ICUAW) characterized by limb and respiratory muscle weakness. ICUAW is associated with worse prognosis, longer ICU stay and increased morbidity and mortality.\n\nPhysical therapy (PT) interventions in the intensive care unit (ICU), can improve patients' outcomes.\n\nHowever, improvements in muscle function achieved with standard physical activity interventions aiming at early mobilization are highly variable due to lack of consistency in definition of the interventions, lack of consideration for the complexity of exercise dose and\u002For insufficient stimulation of muscles during interventions. It has been suggested that modifying early mobilization and exercise protocols towards shorter intervals consisting of higher intensity exercises might result in more optimal stimulation of muscles.\n\nIn the present study the researchers therefore aim to simultaneously assess (by non-invasive technologies) locomotor muscle oxygenation and activation along with the measurements of the load imposed on respiration and circulation during two different training modalities i.e., moderate intensity continuous bed-cycling (endurance training) vs high-intensity alternated by lower intensity periods of bed-cycling (interval training).",[27,57],"Critical Illness",[59,60,61,62,63,64,65,66,67],"ICU acquired muscle weakness","Quadriceps muscle","Near-infrared spectroscopy","Oxygenation","EMG","Early-mobilization","Bed-cycling","Interval exercise","Continuous exercise","RECRUITING","2026-03-16",{"date":71,"type":36},"2026-03-18",{"date":73,"type":36},"2023-02-01",{"date":75,"type":21},"2028-12",{"name":77,"class":43},"KU Leuven",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":5},"100438477","clinical-effectiveness-of-the-picu-up-multifaceted-early-mobility-intervention-for-critically-ill-children-100438477","NCT04989790","Clinical Effectiveness of the \"PICU Up!\" Multifaceted Early Mobility Intervention for Critically Ill Children","Clinical Effectiveness of the \"PICU Up!\" Multifaceted Early Mobility Intervention for Critically Ill Children: A Pragmatic, Stepped-wedge Trial","PICU Up!","Inclusion Criteria:\n\n* Invasive mechanical ventilation via oral or nasal endotracheal tube ≥ 48 hours at 7 a.m. on PICU Day 3\n\nExclusion Criteria:\n\n* Active or anticipated withdrawal of life support within 48 hours\n* Open chest or open abdomen\n* Current use of Extracorporeal Membrane Oxygenation (ECMO)",{"count":87,"type":21},1440,[24],"While mortality in U.S. pediatric intensive care units (PICUs) is improving, surviving children frequently develop persistent physical, cognitive, and psychological impairments. Over half of critically ill children experience potentially preventable PICU-acquired morbidities, with mechanically ventilated children being at greatest risk. In critically ill adults, randomized trials have shown that progressive mobility, started early (within 3 days of initiating mechanical ventilation), decreases muscle weakness and the duration of mechanical ventilation. However, similar randomized studies have not been conducted in the PICU. The investigator's prior studies revealed that less than 10 percent of critically ill children at the highest risk of functional decline are evaluated by a physical or occupational therapist within 3 days of PICU admission. Given the interplay of sedation, delirium, sleep, and immobility in the PICU, single-component interventions, such as sedation protocolization, have not consistently shown benefit for decreasing mechanical ventilation duration. Thus, the investigators developed the first pediatric-specific, interprofessional intervention (PICU Up!) to integrate goal-directed sedation, delirium prevention, sleep promotion, and family engagement into daily PICU care in order to facilitate early and progressive mobility. The investigators have demonstrated the safety and feasibility of this pragmatic, multifaceted strategy in both single-site and multicenter pilot studies. Hence, the next phase of the investigators research is to evaluate the clinical effectiveness and delivery of the PICU Up! intervention across a range of PICU patients and health systems. The investigators propose a pragmatic, stepped-wedge, cluster randomized controlled trial that will include 10 academic and community hospitals in the United States, with the following Aims: 1) Evaluate if the PICU Up! intervention, delivered under real-world conditions, decreases mechanical ventilation duration (primary outcome) and improves delirium and functional status compared to usual care in critically ill children; and 2) Conduct a multi-stakeholder, mixed-methods process evaluation to identify key contextual factors associated with delivery of PICU Up!. If proven effective, the PICU Up! intervention has potential to profoundly change medical care in the PICU and substantially impact public health by improving outcomes for the growing number of pediatric survivors of critical illness.",[91,27,57,92],"Child","Hospital Acquired Pressure Ulcer",[94,95,96,97,98,99,100,101],"physical rehabilitation","post-intensive care syndrome","pediatric intensive care unit","sleep","sedation","delirium","physical therapy","occupational therapy",{"date":71,"type":36},{"date":104,"type":36},"2022-08-08",{"date":106,"type":21},"2026-09-30",{"name":108,"class":43},"Johns Hopkins University",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":44},"100569934","technology-assisted-early-mobilization-program-among-patients-in-the-intensive-care-units-100569934","NCT06700694","Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units","The Effect of Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged ≥ 18 years\n* Being mechanically ventilated ≥ 24 hours\n* Richmond Agitation-Sedation Scale (RASS): 0 to -1\n* No vision, hearing, or body movements restriction\n* With clear consciousness and ability to communicate in Chinese\n* Expected to stay in the ICU \\> 96 hours.\n\nExclusion Criteria:\n\n* Have developed delirium before enrollment (ICDSC \\> 4)\n* With acute physiology and chronic health evaluation (APACHE II) score \\> 25 after ICU admission within 24 hours\n* With muscle weakness caused by severe acute brain injury (e.g., traumatic brain injury or stroke), spinal coral injury, other neuromuscular conduction diseases, or long-term bedridden or hemiplegia.",{"count":117,"type":21},138,[24],"This single-blind, three-group parallel randomized controlled trial will involve 138 patients with critical illness, randomly assigned at a 1:1:1 ratio to the technology-assisted early mobilization group (46 patients), the systematic early mobilization group (46 patients), or the control group (46 patients). The technology-assisted early mobilization group will receive interventions within 72 hours of ventilator use. The interventions include protocol-oriented early mobilization program carried out by physiotherapist and researcher and technology-assisted in-bed activities primarily assisted by family members. The systematic early mobilization group will receive only the similar protocol-oriented early mobilization program within 72 hours of ventilator use. The control group will receive routine rehabilitation as usual. The primary outcomes include occurrence of intensive care unit-acquired weakness (ICUAW). Secondary outcomes include muscle strength, delirium, sleep status, clinical outcomes, activities of daily living, and quality of life. Measurements will be assessed on the day of enrollment, during the ICU stay, on the day of ICU discharge (or up to 28 days), on the day of hospital discharge, and six months after hospital discharge.",[27],"2026-03-05",{"date":123,"type":36},"2026-03-09",{"date":125,"type":36},"2025-03-04",{"date":127,"type":21},"2027-04",{"name":129,"class":43},"Hsiao-Yean Chiu",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":137,"targetDuration":139,"studyType":140,"phases":4,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":44},"100607683","functional-assessment-in-critically-ill-patients-100607683","NCT07191743","Functional Assessment in Critically Ill Patients","Assessment of Physical Function in Critically Ill Patients With the Chelsea Critical Care Assessment Tool (CPAX)","Inclusion Criteria: All adult patients admitted to the Pedro Ernesto University Hospital (HUPE) General ICU over 18 years of age and with an ICU stay greater than or equal to 48 hours will be included.\n\nExclusion Criteria:\n\n* Pregnancy\n* Inability to record the CPAx score within the first 48 hours of ICU admission or on the day of ICU discharge\n* ICU readmission\n* Known comorbidities causing generalized weakness, such as neuromuscular or neurological diseases",{"count":138,"type":21},186,"10 Days","OBSERVATIONAL","This longitudinal, prospective observational study aims to evaluate functional status in critically ill adult patients in the Intensive Care Unit using the Chelsea Critical Care Physical Assessment Tool (CPAx). The primary objective is to analyze CPAx score variation as a potential predictor of clinical outcomes, including mortality and duration of mechanical ventilation. Functional assessments will be performed at intensive care unit (ICU) admission and discharge to monitor changes in physical function and to predict adverse clinical outcomes.",[27,143],"Intensive Care Unit (ICU) Acquired Weakness (ICU - AW)",[145,146,147,148,149,150,151,152],"Critical Care","Intensive Care Units","Physical Therapy Department, Hospital","Muscle Weakness","Functional Status","Physical Functional Performance","Outcome Assessment, Health Care","Rehabilitation","2025-09-21",{"date":155,"type":36},"2025-09-25",{"date":157,"type":36},"2025-01-01",{"date":159,"type":21},"2027-12-01",{"name":42,"class":43},{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":22,"phases":170,"briefSummary":171,"conditions":172,"keywords":176,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":44},"100599795","virtual-reality-in-intensive-care-unit-patient-satisfaction-clinical-and-functional-outcomes-feasibility-100599795","NCT07089134","Virtual Reality in Intensive Care Unit: Patient Satisfaction, Clinical and Functional Outcomes, Feasibility","Efficacy of Immersive Virtual Reality Rehabilitation on Patient Satisfaction and Experience, Functional and Clinical Outcomes, and Its Feasibility in Intensive Care Unit Treatment: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged ≥18 years\n* Glasgow Coma Scale (GCS) score ≥14\n* Richmond Agitation-Sedation Scale (RASS) score between -1 and +1\n* Negative for delirium according to the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)\n* Estimated ICU stay of ≥72 hours\n* Able to communicate in Portuguese\n* Understand and follow verbal instructions\n* Have no psychotic disorders, visual impairment or hearing loss.\n\nExclusion Criteria:\n\n* Hemodynamic instability\n* Signs of respiratory distress\n* Contact isolation for infectious diseases\n* Conditions that limit head and neck movement",{"count":169,"type":21},90,[24],"Background: Virtual reality is recognized as a progressive technology with the potential to enhance the rehabilitation process. Immersive virtual reality-based treatments can improve motor outcomes in physical rehabilitation, reduce stress caused by the intensive care unit environment and maximize patients' recovery processes.\n\nObjective: To analyze the efficacy of rehabilitation using immersive virtual reality on patient satisfaction and experience, functional and clinical outcomes and the feasibility of its application during the hospitalization period in an intensive care unit (ICU).\n\nMethods: This is a randomized controlled clinical trial involving ICU patients aged 18 years or older, with an estimated ICU stay of ≥ 72 hours, the ability to understand and follow verbal instructions and no diagnosis of psychotic disorders, visual impairment, or hearing loss. Patients will be divided into two groups: one undergoing traditional physiotherapy rehabilitation - control group (CG), and the other receiving physiotherapy using immersive virtual reality (IVR group). The following evaluations will be conducted: mobility condition, physical and psychological discomfort, estimated physical activity level, occurrence of delirium, cognitive decline screening, functionality classification, motivation level, patient experience, sense of immersion in the virtual reality environment, patient satisfaction during the rehabilitation process, occurrence of adverse events, and protocol feasibility. Data will be presented in graphs and tables. Results will be considered statistically significant at a 5% significance level (p ≤ 0.05), and all analyses will be performed using SPSS Statistics version 22.\n\nExpected results: The investigators expect to find evidence that rehabilitation using immersive virtual reality can promote and enable a more pleasant and less traumatic experience during the patient's hospitalization, with greater satisfaction and adherence to the proposed rehabilitation, in addition to being an effective tool to optimize patients' functional and clinical outcomes.",[173,174,175],"Hospitalized Patients","ICU Hospitalization","Intensive Care Unit-acquired Weakness",[177,178,179,180,181,182],"virtual reality","rehabilitation","intensive care","stress","satisfaction","patient experience","2025-09-08",{"date":185,"type":36},"2025-09-12",{"date":187,"type":21},"2025-12-15",{"date":189,"type":21},"2026-08-31",{"name":191,"class":43},"Hospital Sirio-Libanes",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":201,"conditions":202,"keywords":203,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":44},"100598320","early-assessment-of-quadriceps-muscle-recovery-by-dynamometry-and-3d-ultrasound-in-intensive-care-patients-under-invasive-mechanical-ventilation-100598320","NCT07069959","Early Assessment of Quadriceps Muscle Recovery by Dynamometry and 3D Ultrasound in Intensive Care Patients Under Invasive Mechanical Ventilation","Early Assessment of Quadriceps Muscle Recovery by Dynamometry and 3D Ultrasound in Intensive Care Patients Under Invasive Mechanical Ventilation: A Monocentric and Prospective Study.","DYNAMOREA","Inclusion Criteria:\n\n* Adults aged \\> 18 years\n* Hospitalized in an ICU\n* Treated with invasive mechanical ventilation (MV) for at least 4 days during their stay (may be extubated at the time of inclusion)\n* Conscious and cooperative patients: ability to respond appropriately to the following commands: open and close eyes, look at me, nod your head, stick out your tongue, raise your eyebrows when I count to five\n* MRC score ≥ 3\u002F5 for the \"Leg Extension\" function on either the left or right side\n* Informed consent obtained (no opposition)\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Fracture or amputation of a lower limb\n* Acute or chronic brain or spinal cord injury responsible for hemiplegia or paraplegia\n* Unstable spinal injury\n* Neurodegenerative or chronic neurological disease\n* Guillain-Barré Syndrome\n* Myasthenia Gravis\n* Acute deep vein thrombosis of the lower limbs treated within the last 48 hours\n* Pre-existing motor deficit in a lower limb before the ICU stay, of any cause\n* Incarcerated or legally protected individuals (guardianship, curatorship)\n* Individuals without social protection",{"count":53,"type":21},"Patients in intensive care often develop acquired muscle weakness (ICUAW or Intensive Care Unit Acquired Weakness) due to immobilization and muscle atrophy. Early mobilization can help reduce weakness and improve functional recovery, but practices vary. Muscle strength assessment, particularly using the MRC (Medical Research Council) score, is crucial, though it has precision limitations. Additional methods, such as manual dynamometry and functional scales, are needed to better track muscle recovery. The quadriceps, important for function, requires early evaluation, but there is a lack of specific data in intensive care to predict medium-term functional recovery.",[27,148],[204,205,179,206,207,208],"dynamometry","muscle weakness","functional recovery","invasive mechanical ventilation","3D ultrasound","2025-07-16",{"date":211,"type":36},"2025-07-17",{"date":213,"type":21},"2025-08-01",{"date":215,"type":21},"2026-11-01",{"name":217,"class":43},"Nantes University Hospital",{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":226,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":229,"conditions":230,"keywords":233,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":44},"100574920","ai-based-muscular-ultrasound-to-assess-intensive-care-unit-acquired-weakness-100574920","NCT06765551","AI Based Muscular Ultrasound to Assess Intensive Care Unit-acquired Weakness","Artificial IntelligenCe Based UlTrasonographic Assessment of IntensiVe CAre UniT-acquired WEakness (ACTIVATE)","ACTIVATE","Inclusion Criteria:\n\n* Patients aged 18 years or above\n* Major elective surgery, e.g. cardiothoracic or abdominal surgery\n* Expected ICU stay \\>1 day postoperatively\n* Healthy, age-machted subjects without ICUAW (recruited from staff of the department of anesthesiology and intensive care medicine)\n\nExclusion Criteria:\n\n* No informed consent\n* Emergency surgery\n* Previous participation in the same study\n* Preexisting neuromuscular disease\n* Preexisting central nervous system disease with residual neuromuscular impairment (e.g. cerebral haemorrhage, stroke, brain tumor)\n* High-dose glucocorticoid therapy (\\>300 mg hydrocortisone or equivalent per day) before or during particiation in the study",true,{"count":228,"type":21},50,"The aim of this observational case-control study is to investigate, whether artificial intelligence can detect ultrasound-derived imaging characteristics typical for intensive care unit-acquired weakness. The main questions it aims to answer are:\n\n1. Is the evaluation of specific parameters of neuromuscular ultrasound using AI-based image analysis suitable for detecting and monitoring critically ill ICU patients with ICUAW?\n2. Do the results of AI-based ultrasound image analysis correlate with:\n\n(A) the severity of ICUAW (B) the visual grading of muscle echogenicity (C) the 30- and 90-day-outcome?",[175,231,232],"Artifical Intelligence","Ultrasound",[234,235,236,237,238],"weakness","neuromuscular","critical illness polyneuropathy","critical illness myopathy","neuromuscular impairment","2025-01-03",{"date":241,"type":36},"2025-01-09",{"date":243,"type":36},"2024-10-01",{"date":245,"type":21},"2026-06-30",{"name":247,"class":43},"Jena University Hospital",{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":256,"conditions":257,"keywords":258,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":44},"100490860","skeletal-muscle-regeneration-in-survivors-of-critical-illness-how-to-prevent-satellite-cell-failure-100490860","NCT05671614","Skeletal Muscle Regeneration in Survivors of Critical Illness: How to Prevent Satellite Cell Failure?","SATELLITE","Eligibility Criteria for group of Critically ill patients:\n\nInclusion Criteria:\n\n* Critically ill patients receiving mechanical ventilation, to be enrolled within 72 hours of admission, who are likely to need 7 days or more of ICU stay\n* Sudden onset of disease, which can be determined in time (such as trauma, stroke, sudden cardiac arrest etc.)\n* Informed consent signed by patient or patient's representative\n\nExclusion Criteria:\n\n* Unlikely to survive 6 months\n* Premorbid downslope functional trajectory or poor performance status (ECOG Gr. 3 or worse) or baseline functional status unknown\n* Bleeding disorder (INR≥1.5 or PLT\\\u003C that would preclude muscle biopsies)\n* Known mitochondrial disease\n* Endocrine crisis as a reason for admission\n* Pregnant women\n\nEligibility Criteria for a control group:\n\nElective hip surgery patients with a very good to excellent performance status, only limited to joint pain (ECOG 0)",{"count":228,"type":21},"Modern intensive care enables patients to survive insults that in the past would have been supralethal. Nonetheless, increased number of survivors suffer from failed functional outcomes associated with prolonged muscle weakness and fatiguability. Whilst alterations of skeletal muscle biology that occur during critical illness slowly disappear over the period of months, muscle weakness remains. Recent pilot studies have shown that muscle weakness is associated with loss and alteration of satellite skeletal muscle cells, which are supposed to proliferate and repair damaged muscle tissue. The pathogenesis of this phenomenon has not been fully understood. In this grant project, we will study function and structure of satellite cells and their organelles (particularly mitochondria) using both classical bioenergetics and advanced microscopic techniques. Satellite cells will be isolated from biopsies taken from critically ill patients with developed muscle weakness in the acute and protracted phase of a disease and after 6 months. In time points, an ultrasound examination of muscle mass will be performed, and metabolism will be assessed using insulin clamps. In an in vitro experiments, we will test also effect of nutritional and anabolic factors and drugs, commonly used in ICU, on satellite cells. In a control branch, cells will be isolated from skeletal muscle of volunteers undergoing elective hip replacement surgery. Results of this study could significantly contribute to understanding of mechanisms leading to ICU acquired muscle weakness and to identify therapeutic strategy in future.",[175],[259,260,261,262],"intensive care unit-acquired weakness","critically ill","skeletal muscle regeneration","satellite cells","2024-12-31",{"date":157,"type":36},{"date":266,"type":36},"2022-08-17",{"date":268,"type":21},"2025-06-30",{"name":270,"class":43},"Charles University, Czech Republic",{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":22,"phases":281,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":44},"100520879","hemodynamic-phenotype-basedcapillary-refill-time-targeted-resuscitation-in-early-septic-shockandromeda-shock-2-100520879","NCT06062303","Hemodynamic Phenotype-Based,Capillary Refill Time-Targeted Resuscitation In Early Septic Shock:ANDROMEDA-SHOCK-2","Hemodynamic Phenotype-Based, Capillary Refill Time-Targeted Resuscitation In Early Septic Shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial (A2)","ANDROMEDA-FR","Inclusion Criteria:\n\n* Consecutive adult patients (≥ 18 years)\n* Patients with septic shock according to Sepsis-3 consensus conference. In short, septic shock is defined as suspected or confirmed infection, plus hyperlactatemia and NE requirements due to persistent hypotension, after a fluid load of at least 1000mL in 1h\n* Patient and\u002For relative informed and having signed the information and consent form for participation in the study\n\nExclusion Criteria:\n\n* More than 4 hours since septic shock diagnosis,\n* Anticipated surgery or acute hemodialysis procedure to start during the 6h intervention period\n* Active bleeding,\n* Do not resuscitate status,\n* Child B-C Cirrhosis\n* Underlying disease process with a life expectancy \\\u003C 90 days and\u002For the attending clinician deems aggressive resuscitation unsuitable\n* Refractory shock (high risk of death within 24h)\n* Pregnancy\n* Concomitant severe acute respiratory distress syndrome\n* Patients in whom CRT cannot be accurately assessed\n* Non-affiliation to a social security scheme or to another social protection scheme\n* Patient on AME (state medical aid) (unless exemption from affiliation\n* Patient under legal protection (guardianship, curatorship)\n* Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants, if applicable\n* Inability, according to the investigator, to understand the study (non-French-speaking patient, cognitive disorders)",{"count":280,"type":21},180,[24],"Over-resuscitation including fluid overload has been associated with increased morbidity (prolonged duration of organ failure) and mortality in septic shock. \"One-size-fits-all\" resuscitation strategies may increase septic shock mortality. However, clinical studies on individualized resuscitation are lacking. Hemodynamic phenotyping may allow to individualize septic shock resuscitation. The ANDROMEDA-SHOCK trial found that a simple clinical and bedside CRT-targeted resuscitation reduces organ dysfunction and 28-day mortality in septic shock. The current study will examine the hypothesis that a CRT-targeted resuscitation based on hemodynamic phenotyping considering within an decision tree usual bedside clinical parameters such as pulse pressure, diastolic blood pressure, fluid responsiveness and cardiac performance can further decrease mortality in septic shock as compared to usual care.",[27,284],"Shock, Septic","2024-12-03",{"date":287,"type":36},"2024-12-05",{"date":289,"type":36},"2024-02-06",{"date":291,"type":21},"2026-05-30",{"name":293,"class":43},"Assistance Publique - Hôpitaux de Paris",{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":303,"conditions":304,"keywords":306,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":317},"100566347","feasibility-and-safety-of-early-mobilization-and-rehabilitation-in-intensive-care-unit-patients-100566347","NCT06653998","Feasibility and Safety of Early Mobilization and Rehabilitation in Intensive Care Unit Patients","Feasibility and Safety of Early Mobilization and Rehabilitation in Intensive Care Unit Patients. A Prospective, Multicenter Study","Inclusion Criteria:\n\n* Patients ≥ 18 years of age admitted to the intensive care units.\n\nExclusion Criteria:\n\n* Patients requiring extracorporeal membrane oxygenation (ECMO).\n* Patients without indication for early mobilisation in the ICU (severe hemodynamic instability, acute brain or spinal injury with rest orders, anaemia (Hb \\<8 mg\u002Fdl), thrombocytopenia (platelets \\<50,000), active systemic inflammatory response according to institutional protocols).\n* Patients in the postoperative period of cardiac transplantation.",{"count":302,"type":21},220,"Intensive Care Unit Acquired Weakness (ICU-AW) is a common complication of critical illnesses, occurring in approximately 50% of ICU patients and is strongly associated with increased morbidity, physical impairments, and both short- and long-term mortality. The main characteristics of ICU-AW are symmetrical generalised muscle weakness affecting both respiratory and limb muscles; however, the clinical phenotype may differ depending on age, disease burden, length of ICU stay, and mechanical ventilation duration.\n\nThe objective of the present study is to evaluate the feasibility achieved and the safety outcomes reported in a cohort of critically ill patients who undergo early mobilisation and rehabilitation in intensive care units. This research is a multicentre prospective cohort study.",[27,305],"Intensive Care Unit Patients",[146,148,307,152],"Early Mobilization","2024-10-21",{"date":310,"type":36},"2024-10-23",{"date":312,"type":36},"2024-05-10",{"date":314,"type":21},"2025-04",{"name":316,"class":43},"Claudia Aristizábal",4]