[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intensive-care-units-icus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intensive-care-units-icus":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,49,82,114,150,172,201,228,253,286,315,339],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100622004","phase-4-safety-and-efficacy-of-esketamine---dexmedetomidine-combination-versus-dexmedetomidine-monotherapy-for-hyperactive-delirium-in-icu-patients-on-non-invasive-respiratory-support-seed-nirs-trial-study-protocol-of-a-randomized-controlled-trial-100622004",false,"NCT07377981","Safety and Efficacy of Esketamine - Dexmedetomidine Combination Versus Dexmedetomidine Monotherapy for Hyperactive Delirium in ICU Patients on Non-Invasive Respiratory Support (SEED-NIRS Trial): Study Protocol of a Randomized Controlled Trial","SEED-NIRS","Inclusion Criteria:\n\n1. Age ≥18 years and ≤80 years at the time of randomization;\n2. Hospitalized in the ICU (with an expected ICU stay \\>24 hours);\n3. Patients with hyperactive delirium: meeting criteria for Confusion Assessment Method for the ICU (CAM-ICU)\\[19\\] positivity (i.e., acute onset or fluctuating course plus inattention, and at least one secondary criterion-disorganized thinking or altered level of consciousness) and having agitation which is diagnosed if the Richmond Agitation-Sedation Scale (RASS) score\\[20\\] is superior or equal to +1. (The RASS and CAM-ICU are used to assess sedation and delirium levels. Hyperactive delirium is defined as CAM-ICU positive with RASS \\> +1);\n4. Receiving non-invasive respiratory support (eg. high-flow nasal cannula, CPAP, or non-invasive ventilation) at least for \\>24 hours.\n\nExclusion Criteria:\n\n1. Known or suspected allergy or Contraindications to any of the study drugs;\n2. Severe arrhythmias (e.g., ventricular fibrillation, second- or third-degree atrioventricular block, sick sinus syndrome, ventricular tachycardia, QTc interval ≥470 ms, severe bradycardia (heart rate \\\u003C40 beats per minute), etc.), or left ventricular ejection fraction (LVEF) \\\u003C30%;\n3. Recent administration of esketamine, dexmedetomidine or haloperidol within previous 72 hours.\n4. Pregnancy or lactation;\n5. Conditions that may affect efficacy assessment or cognitive function testing, such as blindness, deafness, aphasic, or coma patients;\n6. History of epilepsy or seizures;\n7. Patients with an estimated survival period of less than 48 hours as judged by the investigator;\n8. Neuropsychiatric conditions per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) that may introduce bias (e.g., active substance use disorder, psychosis, etc.), including alcoholism, drug abuse, or use of psychotropic medications;\n9. Patients receiving non-invasive respiratory support via a tracheostomy;\n10. Patients with untreated or inadequately treated hyperthyroidism;\n11. Severe hepatic insufficiency (Child-Pugh grade C);\n12. Severe renal dysfunction, defined as: chronic renal insufficiency with a glomerular filtration rate (GFR) ≤ 29 mL\u002Fmin\u002F1.73 m²; or subjects on long-term maintenance hemodialysis or peritoneal dialysis;\n13. A history of sleep disorders requiring medical intervention within the past month;\n14. Patients or their legally authorized representatives (family members) who are unable to cooperate or unwilling to provide written informed consent;\n15. Other conditions deemed unsuitable for inclusion by the investigators.","ALL","18 Years","80 Years",{"count":20,"type":21},388,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This investigator-initiated, randomized, controlled, single-blind, superiority trial aims to assess the efficacy and safety of esketamine combined with dexmedetomidine for the management of agitation or delirium in intensive care unit (ICU) patients receiving non-invasive respiratory support. The primary endpoint is a clinically prioritized hierarchical composite endpoint within 28 days, including intubation or tracheostomy, delirium duration, and agitation duration.",[27,28,29,30,31,32,33],"Dexmedetomidine","Ketamine","Analgesia","Respiratory Therapy","Intensive Care Units (ICUs)","Agitation","Sedation and Analgesia",[35,29,32,27,28,31,30],"Sedation and analgesia","NOT_YET_RECRUITING","2026-06-30",{"date":39,"type":40},"2026-07-02","ACTUAL",{"date":42,"type":21},"2026-08-01",{"date":44,"type":21},"2029-01-01",{"name":46,"class":47},"The First Affiliated Hospital with Nanjing Medical University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":70,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100622941","the-effect-of-changes-in-the-frequency-of-endotracheal-tube-repositioning-in-intensive-care-units-on-the-prevention-of-oral-mucosal-pressure-injuries-100622941","NCT07390162","The Effect of Changes in the Frequency of Endotracheal Tube Repositioning in Intensive Care Units on the Prevention of Oral Mucosal Pressure Injuries","PreventionMMPI","Inclusion Criteria:\n\n* The study will include patients over the age of 18, receiving MV support with oral ETT, with no tissue loss\u002Fdamage in the oral mucosa at the time of admission to the ICU, who have been intubated for less than 24 hours, with an APACHE II score ≤24, and whose first-degree relatives or legal presentative have given consent for their participation in the study.",{"count":57,"type":21},230,[59],"NA","Intensive care units (ICUs) are care centers equipped with a wide range of technological tools and devices used to provide the highest level of care to individuals whose lives are at risk, requiring a multidisciplinary team approach. Patients may require respiratory support from a ventilator to maintain breathing. In the intensive care unit, patients' breathing is maintained using a medical device called an endotracheal tube (ETT). ETTs can cause injuries due to the constant pressure they exert on the patient's mouth and lip area. Therefore, nurses must secure the ETT at specific times to different points in the mouth area (right and left sides of the mouth) to prevent these injuries. Injuries to the mucosa caused by medical equipment are defined as \"mucosal membrane pressure injuries (MMPI).\" One such injury is an injury to the mouth. Injuries occurring in the mouth are caused by the pressure of the tubes that enable the patient to breathe in and out.\n\n\"The Effect of Changes in the Frequency of Endotracheal Tube Repositioning in Intensive Care Units on the Prevention of Oral Mucosal Pressure Injuries\" is a doctoral thesis study; the aim of this study is to investigate the effect of differences in the time interval for changing the position of the tube in the lip region on the prevention of injuries occurring in the mouth in patients monitored with ETT in the ICU. A review of the literature revealed that there are gaps in studies conducted at the international or national level on this subject, and that there is no definitive time guideline for changing (repositioning) the tube in the lip area.\n\nThe study will include patients over the age of 18 who are being monitored with an ETT in their mouth, who did not have any injuries in the mouth area at the time of admission to the ICU, who have not had the tube in their mouth for more than 24 hours, who are in moderate to good general condition, and whose first-degree relatives or legal presentative have given permission for them to participate in the study. In the study, the follow-up and evaluation of patients will be limited to fourteen days after tube insertion. Exclusion Criteria; Differences in respiratory support, Pre-existing artificial airway, Oncological conditions, Neurological and behavioral factors, Positional constraints, Sensory\u002Fperceptual impairment, Pre-existing injury. Patients who are discharged or transferred during the fourteen-day follow-up period will be excluded from the study. According to the sample calculation for the study, a total of 230 patients (115 volunteers in the 4-hour group and 115 volunteers in the 8-hour group) will be sufficient. In the study, patients will be stratified according to their APACHE II scores. ICU nurses are not bound by any specific time for securing the ETT. Nurses positioned the tube fixation site at the right lip edge\u002Fleft lip edge\u002Fmid-lip line; however, since they were not bound by a specific time-based rule, tube care was nurse-specific. In this study, the location of tube fixation will be recorded through observation to determine the effect of tube fixation on the formation of oral injuries. This study is planned to be completed within a 24-month timeframe between May 30, 2026, and June 15, 2027.\n\nThis research is a scientific research (doctoral thesis) study. The daily tube care of volunteers is already in place, and we emphasize that this research will not affect\u002Finterfere with the treatment and follow-up of volunteers, and that volunteers will not be negatively affected by the study in any way. The principal investigator will randomly assign volunteers being monitored with ETT to groups using a computer system and will request nurses to reposition their ETTs based on the time intervals (4 hours-8 hours) within these groups. At the same time, the researcher will collect relevant clinical data that may affect pressure injuries in patients (age, gender, smoking history, body mass index, medical history, ICU admission diagnosis, SOFA, RASS and APACHE II scores, Glasgow Coma Scale, laboratory findings (C-reactive protein, white blood cell, Hemoglobin, Hematocrit, Total Protein, Albumin, pH, PO2, Blood Sugar Level), Nutritional Status (Route and Type of Nutrition, Product), Medication Support (Sedatives, Inotropes, Antibiotics, Steroids), ETT-Related Data (Number, Depth, Fixation Site, Repositioning Time), Eilers Oral Assessment Guide and Oral Care Frequency, Braden Pressure Ulcer Risk Assessment Scale and Overall Body Pressure Ulcer Presence, Reaper Oral Mucosa Pressure Injury Scale Grade data, etc.). The follow-up period in the study will be fourteen days, during which the principal investigator will record the patients' personal health data mentioned above and terminate the follow-up of patients who develop pressure injuries in the oral mucosa. Our expectation from the study is that no injuries will occur in the mouth. In the event of a possible injury, the intervention will be terminated immediately.",[62,63,64,65,66,67,31,68,69],"Mucosal Wound","Mucosal Erosion","Mucosal Irritation","Endotracheal Intubation Fixation","Endotracheal Tube Position","Repositioning","Adult Patients","Pressure Ulcer Prevention",[71,31,72,67,73],"mucosal membrane pressure injury","Endotracheal intubation fixation","pressure ulcer prevention","2026-06-24",{"date":76,"type":40},"2026-06-25",{"date":37,"type":21},{"date":79,"type":21},"2027-06-15",{"name":81,"class":47},"Hacettepe University",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":93,"conditions":94,"keywords":99,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":48},"100587044","ultrasound-evaluation-of-cardiac-function-during-spontaneous-breathing-trials-100587044","NCT06923267","Ultrasound Evaluation of Cardiac Function During Spontaneous Breathing Trials","Ultrasound Evaluation of Cardiac Function During Three Spontaneous Breathing Trials in Intensive Care Unit : A Prospective Interventional Study","ATARI","Inclusion Criteria:\n\n* Intubated patient undergoing invasive mechanical ventilation for at least 24 hours and scheduled for a spontaneous breathing trial\n* Richmond Agitation Sedation Scale (RASS) between -1 and +1\n* Patient at high risk of re-intubation with at least one of the following criteria:\n\n  * Underlying cardiac disease (left ventricular dysfunction with left ventricular ejection fraction ≤ 45%, documented ischemic heart disease, chronic atrial fibrillation, known history of cardiogenic pulmonary edema)\n  * Underlying respiratory disease (COPD, Emphysema, bronchial dilatation, asthma, obesity\u002Fhypoventilation syndrome, restrictive lung disease)\n\nExclusion Criteria:\n\n* Neuromuscular pathology (myasthenia type) preceding hospitalization\n* Pregnant or breast-feeding women\n* Patient already included in the study\n* Protected person (under guardianship or curatorship)\n* Person under court protection\n* Person not affiliated to a social security scheme",{"count":91,"type":21},24,[59],"The goal of this clinical trial is to evaluate the evolution of a cardiac ultrasound index (E\u002FE') during 3 spontaneous breathing trials in Intensive Care Unit (ICU) adults (over 18 years) patients at risk for weaning failure. The main objective is to find out which spontaneous breathing trial is the least demanding in terms of heart work.\n\nInvestigators will compare 3 consecutive spontaneous breathing trials in a random order to see if one is superior to the others.\n\nParticipants will not have to perform any specific procedure apart from breathing without respiratory support during the spontaneous breathing trial. During these trials, the investigator will perform cardiac ultrasound measurements.",[95,96,97,98,31],"Weaning Invasive Mechanical Ventilation","Weaning-induced Pulmonary Edema","Weaning Failure of Mechanical Ventilation","Spontaneous Breathing Test",[100,101,102,103],"Humidified high flow","Cardiac ultrasound","Spontaneous breathing trial","T-Piece","RECRUITING","2026-05-21",{"date":107,"type":40},"2026-05-22",{"date":109,"type":40},"2025-04-30",{"date":111,"type":21},"2027-05",{"name":113,"class":47},"Centre Hospitalier Régional d'Orléans",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":126,"studyType":127,"phases":4,"briefSummary":128,"conditions":129,"keywords":137,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":48},"100600102","rehabilitation-practices-in-critically-ill-patients-receiving-invasive-mechanical-ventilation-in-the-intensive-care-unit-100600102","NCT07093125","Rehabilitation Practices in Critically Ill Patients Receiving Invasive Mechanical Ventilation in the Intensive Care Unit.","An Observational Study on Rehabilitation Practices in the ICU for Critically Ill Patients Undergoing Invasive Mechanical Ventilation - Report (REPOrt)","REPOrt","Inclusion Criteria:\n\n* Patients admitted to a participating ICU\n* Adult patients (aged 16 years or older, depending on local regulations for the definition of \"adults\")\n* Patients who have received invasive ventilation for at least 48 hours\n* Patients who have obtained written informed consent from the patient or next of kin (if local legislation demands so)\n\nExclusion Criteria:\n\n• Patients admitted for withdrawn of life sustain therapy","16 Years","100 Years",{"count":125,"type":21},2400,"28 Days","OBSERVATIONAL","This international, multicenter, observational study aims to describe rehabilitation practices in Intensive Care Units (ICUs) worldwide.\n\nThe primary objective is to provide an overview of current rehabilitation strategies used in ICUs globally.\n\nSecondary objectives include assessing the relationship between rehabilitation and key ICU outcomes such as ICU and hospital mortality, length of stay, duration of invasive ventilation, extubation failures, and long-term outcomes including quality of life and functional performance 28 days post-ICU discharge.\n\nThe study will also compare rehabilitation practices across different geographic and economic regions to identify potential disparities. The study is structured into three modules, with participation contingent on local resources and feasibility.\n\nThe BASIC Module (mandatory for all centers) gathers fundamental data on rehabilitation practices and their association with patient outcomes.\n\nThe EXTENDED Module (optional) collects more detailed information on the type, timing, duration, and safety of rehabilitation interventions, including passive exercises, active mobilization, respiratory therapies, dysphagia training, occupational therapy, and cognitive support.\n\nThe EXTENDED FOLLOW-UP Module (optional) evaluates the patient's quality of life and functional recovery 28 days after ICU discharge. By examining global rehabilitation practices and their impact on patient outcomes, this study aims to improve rehabilitation strategies in ICUs, contributing to better patient care, recovery, and long-term health outcomes.",[130,131,31,132,133,134,135,136],"Mechanical Ventilation","Pulmonary Rehabilitation","Quality of Life (QOL)","Outcome Assessment","Extubation Failure","Mortality","Critical Care",[138,130,139,140],"Pulmonary rehabilitation","Intensive Care Unit (ICU)","Rehabilitation Outcomes","2026-04-27",{"date":143,"type":40},"2026-05-04",{"date":145,"type":40},"2025-10-01",{"date":147,"type":21},"2029-10-01",{"name":149,"class":47},"Universita degli Studi di Genova",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":156,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":127,"phases":4,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":48},"100565122","continuous-connected-patient-care-ccpc-a-pilot-testing-a-novel-device-for-continuous-vitals-monitoring---department-of-anesthesia-at-phc-100565122","NCT06638073","Continuous Connected Patient Care (CCPC), a Pilot Testing a Novel Device for Continuous Vitals Monitoring - Department of Anesthesia at PHC","Inclusion Criteria:\n\n* 19 years or older\n* Patients that have undergone a non-cardiac surgery at SPH requiring an inpatient hospital stay\n* Peri-op patients who are in the Surgical High Acuity Unit (SHAU) and those followed by Anesthesia Perioperative Outreach team on the ward\n* Living within British Columbia, Canada and in an area that is covered by Bell cellular network\n\nExclusion Criteria:\n\n* Patient refusal\n* Lack of capacity to consent to the study (including having received sedative or general anesthetic within the past 24 hours)\n* Unable to use (or does not have a caregiver who can help put on) study monitoring device at home\n* Unable to complete (or does not have a caregiver who can help complete) study questionnaires by electronic (mobile, tablet, or computer), paper, nor phone\n* No access to cell phone nor landline at home to receive follow-ups\n* Preoperatively known to be discharged to a nursing home or rehabilitation facility\n* Known allergic reactions to any part material of study devices","19 Years",{"count":158,"type":21},50,"To confirm feasibility and accessibility of the CCPC Platform (Oxymotion, Bridge Health Solutions medication adherence software, CloudDX home kit) in two different environments - in hospital and at-home, in patients undergoing non-cardiac surgery.",[161,31],"Surgical Procedure, Unspecified","2026-03-10",{"date":164,"type":40},"2026-03-12",{"date":166,"type":40},"2025-03-13",{"date":168,"type":21},"2026-06-20",{"name":170,"class":171},"Medtronic - MITG","INDUSTRY",{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":185,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":48},"100617811","body-lateralization-and-its-effects-on-respiratory-drive-ventilation-and-pulmonary-aeration-in-critically-ill-patients-100617811","NCT07323472","Body Lateralization and Its Effects on Respiratory Drive, Ventilation, and Pulmonary Aeration in Critically Ill Patients","Analysis of Respiratory Drive Activation, Ventilation, and Pulmonary Aeration Resulting From Body Lateralization in Critically Ill Patients Under Mechanical Ventilation","LATLUNG","Inclusion Criteria:\n\n* Patients of both sexes will be included;\n* Aged ≥ 18 years;\n* BMI 18-35 kg\u002Fm²;\n* Under invasive mechanical ventilation via orotracheal tube for ≥ 24 hours and expected to remain on mechanical ventilatory support for at least 48 hours;\n* Sedated (Richmond Agitation-Sedation Scale \\[RASS\\] -1 to -4);\n* Well adapted to protective ventilation strategies in VCV or PSV modes;\n* Presenting neural respiratory drive evidenced by a drop in Delta Pocc and\u002For the presence of assisted cycles;\n* Hemodynamically stable (mean arterial pressure between 60-120 mmHg, systolic arterial pressure between 90-180 mmHg, diastolic arterial pressure between 60-100 mmHg, and heart rate between 50-150 bpm) with or without vasoactive drugs at the time of data collection (\\> 0.1 to 0.3 mcg\u002Fkg\u002Fmin);\n* Respiratory stability, no use of accessory muscles and target SpO₂ achieved;\n* No indication for nebulization or heated humidification at the time of collection;\n* Positive tolerance test for lateral decubitus positioning;\n* Chest circumference of 78-87.9 cm (XS), 88-99.9 cm (S), or 100-111.9 cm (M).\n\nExclusion Criteria:\n\n* Patients presenting medical restrictions to body repositioning, or to the use of EIT or sEMG;\n* Those in therapeutic failure;\n* Individuals with spinal cord injury, brain injury, or stroke with a history of functional loss and respiratory impairment prior to hospitalization;\n* Neurological diseases affecting respiratory myoelectric conduction;\n* History of postural deformities, diaphragmatic abnormalities, or colostomy bag;\n* Unstable fracture (lower or upper limbs in proximal regions or thorax);\n* Pleural effusion requiring drainage;\n* Presence of drains in the thoracic and\u002For abdominal regions;\n* Unstable intracranial pressure;\n* Pregnant patients;\n* Immediate postoperative period of orthopedic surgeries;\n* Use of mucolytics;\n* Open ventriculostomy for drainage;\n* Uncontrolled agitation;\n* Pacemaker or implantable cardioverter-defibrillator;\n* Pneumothorax;\n* Use of neuromuscular blockers;\n* Active tuberculosis;\n* Traction devices;\n* Active bleeding;\n* Suspected or confirmed pulmonary embolism without prior treatment within 24 hours;\n* Presence of a large mass in the right and\u002For left hemithorax;\n* History of cardiopulmonary arrest within the past 24 hours under neuroprotection;\n* In the total weaning phase from IMV and\u002For tracheostomy and\u002For enteral feeding tube and\u002For scheduled CT scan within the next 6 hours;\n* Intolerance to the TLA test (SpO₂ drop \\\u003C92% or ≥20% from baseline, need for FiO₂ increase \\>50% or ≥20% from baseline, need for PEEP increase, or hemodynamic instability within the first 5 minutes of lateralization testing);\n* Those who refuse to provide consent, as determined by the legal representative.",{"count":181,"type":21},30,[59],"The goal of this quasi-experimental study is to investigate how different body positions, performed through Automatic Lateralization Therapy, affect respiratory drive, ventilation, and pulmonary aeration in critically ill adult patients under mechanical ventilation. The main questions this study aims to answer are:\n\n* Does Automatic Lateralization Therapy, modify respiratory drive, as measured by P0.1, estimated Pmus, and sEMG of the diaphragm and parasternal muscles?\n* Is there an association between respiratory drive, ventilation, and pulmonary aeration measured by Electrical Impedance Tomography (EIT) in different body positions promoted by Automatic Lateralization Therapy ?\n\nDoes combining Automatic Lateralization Therapy, with Flow Bias improve physiological and functional outcomes compared to Automatic Lateralization Therapy, without Flow Bias?\n\nParticipants will:\n\n* Be positioned in different lateralization strategies using Automatic Lateralization Therapy, while under mechanical ventilation;\n* Have respiratory parameters and ventilation images assessed by EIT and sEMG;\n\nParticipate only during their ICU stay, with no need for additional visits after discharge.",[31],[186,187,188,189,190,191],"Automatic lateralization therapy","Critical illness","Continuous lateral rotation","Electrical impedance tomography","Surface electromyography","Respiratory muscles","2026-01-08",{"date":194,"type":40},"2026-01-09",{"date":196,"type":40},"2026-01-01",{"date":198,"type":21},"2027-12-30",{"name":200,"class":47},"University of Pernambuco",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":209,"targetDuration":211,"studyType":127,"phases":4,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":48},"100601367","surface-electrical-myography-oxygen-consumption-effort-and-weaning-in-the-mechanically-ventilated-patient-in-the-intensive-care-unit-100601367","NCT07109570","Surface Electrical Myography, Oxygen Consumption, Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit","Surface Electrical Myography, Oxygen Consumption (VO2), Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit (ICU): SERA-Effort Study","SERA-Effort","Inclusion Criteria:\n\n* 18 years of age or older\n* Esophageal catheter in situ (standard of care)\n* Eligible for an SBT in the near future according to the LUMC SBT protocol currently valid\n\nExclusion Criteria:\n\n* Severe cardiac failure NYHA class IV without mechanical support (LVAD or Impella)\n* COPD Gold IV\n* Pregnancy\n* Patients with ECMO",{"count":210,"type":21},60,"2 Days","The goal of this observational study is to measure effort using esophageal pressure measurements, oxygen consumption and diaphragm activity in mechanically ventilated Intensive Care Unit patients during a Spontaneous Breathing Trial. The main question aims to answer whether the sEMG signal derived from the SERA device, effort parameters and oxygen consumption have an association with weaning failure.\n\nParticipants will be measured while performing a spontaneous breathing trial.",[214,31,215,130,216,217,218],"Critical Illness","Weaning Failure","Spontaneous Breathing Trial","Diaphragm Electrical Activity","Oxygen Consumption","2025-11-20",{"date":221,"type":40},"2025-11-26",{"date":223,"type":40},"2025-07-08",{"date":225,"type":21},"2029-06",{"name":227,"class":47},"Leiden University Medical Center",{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":235,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":22,"phases":238,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":4},"100596527","prevention-of-phlebitis-infiltration-and-extravasation-with-infusion-monitoring-system-100596527","NCT07046624","Prevention of Phlebitis, Infiltration and Extravasation With Infusion Monitoring System","Development of an Infusion Monitoring System to Prevent Phlebitis, Infiltration and Extravasation and Its Application in the Intensive Care Unit","Inclusion Criteria:\n\n* 18 years of age and older\n* Receiving medication via peripheral intravenous catheter,\n* Monitored daily for signs of phlebitis, infiltration and extravasation,\n* Patients who can speak\n\nExclusion Criteria:\n\n* Unconscious patients",true,{"count":237,"type":21},102,[59],"Peripheral venous catheter complications are conditions that are frequently seen in intensive care clinics and require nursing care. The most common complications are phlebitis, infiltration and extravasation. Nurses should take the necessary precautions to prevent these complications from developing.. Therefore, this planned thesis study aims to establish an infusion monitoring system and evaluate its effectiveness in early detection of complications related to peripheral intravenous catheters. The research is planned as a randomized controlled experimental study. The study will be conducted in Ordu State Hospital General Intensive Care Unit 1 and General Intensive Care Unit 3 clinics. The universe of the study will consist of patients receiving inpatient treatment in General Intensive Care Unit 1 and General Intensive Care Unit 3 clinics. The sample size will be determined by g-power analysis after a two-month preliminary follow-up. Data will be collected with the \"Clinical Follow-up Form\", \"Patient Information Form\", and \"Complication Follow-up Form\". The clinics included in the study will be divided into two groups as experimental and control groups. First, the frequency of complications will be determined in the experimental and control groups. Then, while the control group continues its routine protocol and applications, an infusion follow-up system will be developed in the experimental group and will be used by nurses in patient care. In the final stage, the frequency of peripheral venous catheter complications will be determined again. Data will be evaluated using the SPSS 22.0 package program at a significance level of p\\\u003C0.05 and a confidence interval of 95%.",[241,31,242,243],"Extravasation","Phlebitis","Infiltration","2025-11-14",{"date":246,"type":40},"2025-11-17",{"date":248,"type":21},"2025-11-08",{"date":250,"type":21},"2026-07-08",{"name":252,"class":47},"Ordu University",{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":263,"briefSummary":264,"conditions":265,"keywords":271,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":48},"100606160","effects-of-artificial-intelligence-nurse-orientation-program-on-psychological-outcomes-and-length-of-hospital-stay-in-intensive-care-unit-100606160","NCT07171944","Effects of Artificial Intelligence Nurse Orientation Program on Psychological Outcomes and Length of Hospital Stay in Intensive Care Unit","Effects of AINurse Orientation Program on Psychological Outcomes and Length of Hospital Stay: A Randomized Controlled Trial","AINURSE-OP","Inclusion Criteria:\n\n* Intensive care unit confusion assessment scale (CAM-ICU scale) score of 0-2\n* Age 18 years or older\n* Hospitalized in the intensive care unit for at least 24 hours\n* Glasgow coma scale score of 13-14-15 points\n* Richmond Agitation Sedation Scale (RASS) score between -1 and +1\n* No hearing problems\n\nExclusion Criteria:\n\n* Intensive care unit confusion assessment scale (CAM-ICU scale) score of 6-7\n* Any psychiatric illness or impaired brain function\n* Defined hearing loss\n* Advanced dementia\n* Younger than 18 years of age\n* Richmond Agitation Sedation Scale (RASS) score outside the range of -1 to +1\n* Who use sedative medication\n* History of surgery or disease around the ear",{"count":262,"type":21},10,[59],"Artificial intelligence (AI), now an integral part of healthcare services and presents numerous opportunities. Customized treatment plans, clinical decision support systems, predictive analysis for disease prevention, patient engagement and education, quality improvement, and error reduction are some of these opportunities. In the context of delirium prevention, risk assessment, and treatment planning, the AI-supported system AI-AntiDelirium is designed to standardize the approach to delirium management in alignment with the PADIS guidelines. A randomized controlled trial evaluating the effectiveness of this system found that the workload of nurses decreased, facilitated early diagnosis and prevention of delirium, and recommended evidence-based and individualized delirium interventions. A systematic review concluded that AI applications did not significantly impact the length of hospital stay and emphasized the need for further research. Also, AI platforms contributed to positive results in reducing anxiety and depression in patients. Furthermore, systematic reviews have demonstrated that AI-based chatbots are effective in alleviating symptoms of depression and anxiety. However, the literature includes a limited number of patient education programs specifically designed to prevent or manage delirium through AI-based approaches. Notably, there is a lack of studies comparing the effectiveness of AI-supported educational interventions with those delivered directly by nurses.\n\nThe goal of this clinical trial is to develop a structured AINurse and Human Nurse orientation training program for intensive care unit (ICU) patients and compare the effects of these training programs on ICU patients' delirium-free days, level of anxiety and depression, and length of stay in the ICU. Hypotheses of the study:\n\nH1: Patients who receive the structured AINurse patient orientation training program will have longer delirium-free days than patients who receive Human Nurse orientation training.\n\nH2: Patients who receive the structured AINurse patient orientation training program will have lower levels of anxiety and depression than patients who receive the Human Nurse orientation training.\n\nH3: Patients who receive the structured AINurse patient orientation training program will have shorter lengths of stay in the intensive care unit than patients who receive the Human Nurse orientation training.\n\nResearchers will compare the AINurse patient orientation training program and the orientation training program provided by human nurses in terms of patients' delirium-free days, level of anxiety and depression, and length of stay in the ICU.\n\n* Those in the intervention group will receive the AINurse orientation training program twice daily for 3 days.\n* Participants in the control group will receive face-to-face structured orientation training from researchers twice daily for 3 days.\n* Delirium-free day assessment, anxiety and depression will be evaluated for patients in both groups over 3 days.\n* The length of stay in the intensive care unit will be monitored for patients in both groups.",[266,267,31,268,269,136,270],"Delirium","Anxiety and Depression","Artificial Intelligence (AI)","Nurse","Orientation",[266,272,273,274,275,276,269],"Artificial intelligence","Anxiety and depression","Intensive care unit","critical care","Orientation Training","2025-09-10",{"date":279,"type":40},"2025-09-15",{"date":281,"type":21},"2025-11-01",{"date":283,"type":21},"2026-11-01",{"name":285,"class":47},"Koç University",{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":22,"phases":295,"briefSummary":296,"conditions":297,"keywords":300,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":48},"100602782","neuromuscular-electrical-stimulation-in-critically-ill-patients-aged-80-and-over-100602782","NCT07127991","Neuromuscular Electrical Stimulation in Critically Ill Patients Aged 80 and Over","Impact of Neuromuscular Electrical Stimulation on Muscle Mass, Strength, and Functionality in Critically Ill Oldest Old Patients: a Randomized Controlled Trial","NMES-ICU80","Inclusion Criteria:\n\n* People aged 80 years or older.\n* Hospitalized in the Adult Critical Care Unit of Dr. Hernán Henríquez Aravena Hospital in Temuco.\n* Estimated mechanical ventilation time greater than 72 hours.\n\nExclusion Criteria:\n\n* Patients with prior neurological complications.\n* Patients with severe dependence prior to admission.\n* Patients with difficult-to-manage hemodynamic instability.\n* Patients with accessory elements that limit assessment.\n* Patients with lower limb amputation.\n* Patients in the prone position.\n* Patients with loss of skin integrity.\n* Patients expected to remain in the unit for less than 72 hours.\n\nPatients transferred from other services with a stay of more than 72 hours.",{"count":181,"type":21},[59],"The aim of this clinical trial is to evaluate the effectiveness of Medium-Frequency Neuromuscular Electrical Stimulation, in combination with standard physical therapy, compared to standard physical therapy alone, on muscle mass, muscle strength, and functionality in critically ill patients aged 80 and over during their hospital stay. The safety of the intervention and the standardization of protocol parameters will also be assessed.\n\nThe main research questions are:\n\n* Does the implementation of a standardized Medium-Frequency Neuromuscular Electrical Stimulation protocol, in combination with standard physical therapy, compared to standard physical therapy alone, help attenuate the loss of skeletal muscle mass, strength, and functionality in critically ill patients aged 80 and over?\n* Is the use of this protocol and its proposed parameters safe for critically ill patients aged 80 and over? The study will consist of applying a standardized Medium-Frequency Neuromuscular Electrical Stimulation protocol to oldest old patients admitted to the Intensive Care Unit of Dr. Hernán Henríquez Aravena Hospital in Temuco, Chile. The sample will consist of oldest old participants (≥80 years), who will be randomly divided into two subgroups: a control group that will receive standard physical therapy typically provided during hospitalization, and an experimental group that will receive the same standard therapy plus Medium-Frequency Neuromuscular Electrical Stimulation, which will begin within the first 48 hours of Intensive Care Unit admission.\n\nThe following variables will be assessed in both groups (control and experimental), from Intensive Care Unit admission to hospital discharge:\n\n* Skeletal muscle mass characteristics and evolution (quadriceps femoris and anterior tibialis muscle thickness), measured by ultrasonography.\n* Handgrip strength, measured using a digital hand dynamometer.\n* Inspiratory muscle strength, assessed using a pimometer.\n* Peripheral muscle strength, evaluated with the Medical Research Council Sum Score (MRC-SS).\n* Functionality, assessed by the Functional Status Score for the Intensive Care Unit (FSS-ICU) .\n* Independence in basic activities of daily living, measured using the Barthel Index.\n* Quality of life, evaluated using the Short Form-36 Health Survey (SF-36).\n* Cognitive impairment, assessed through the Montreal Cognitive Assessment (MoCA).\n* Frailty, measured using the Clinical Frailty Scale (CFS).",[31,298,299],"Muscle Atrophy or Weakness","Old and Very Old People",[301,302,303,304,305],"MUSCLE ATROPHY","FUNCTIONAL STATUS","ICU","OLDER ADULTS","NMES","2025-08-13",{"date":308,"type":40},"2025-08-17",{"date":310,"type":21},"2025-09",{"date":312,"type":21},"2026-12",{"name":314,"class":47},"Universidad de La Frontera",{"id":316,"slug":317,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":235,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":127,"phases":4,"briefSummary":323,"conditions":324,"keywords":328,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":48},"100585910","adaptation-of-the-intensive-care-unit-specific-pressure-injury-risk-scale-to-turkish-raps-icu-100585910","NCT06908512","Adaptation of the Intensive Care Unit-specific Pressure Injury Risk Scale to Turkish (RAPS-ICU)","Turkish Adaptation, Validity and Reliability of the Intensive Care Unit-specific Pressure Injury Risk Assessment Scale","Inclusion Criteria:\n\n* 18 years of age or older,\n* Staying in the Intensive Care Unit for at least 1 day,\n* Agreeing to participate in the study by themselves or a family member.\n* Volunteering to participate in the research\n* Full orientation and no psychiatric problems\n\nExclusion Criteria:\n\n\\- Having communication problems",{"count":210,"type":21},"The aim of this study was to evaluate the translation, cross-cultural fit, and psychometric properties of the ICU-specific pressure injury risk scale",[325,326,31,327],"Pressure Injury","Reliability and Validity","Assessment Scale",[325,326,329,327],"Intensive Care Units","2025-03-26",{"date":332,"type":40},"2025-04-03",{"date":334,"type":21},"2025-03-30",{"date":336,"type":21},"2025-11-12",{"name":338,"class":47},"Harran University",{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":22,"phases":348,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":4},"100581381","assessment-of-the-peep-responsiveness-to-titrate-end-expiratory-pressure-and-of-the-need-for-muscle-relaxation-during-prone-positioning-in-moderate-to-severe-acute-respiratory-distress-syndrome-a-master-protocol-100581381","NCT06849570","Assessment of the PEEP Responsiveness to Titrate End-expiratory Pressure and of the Need for Muscle Relaxation During Prone Positioning in Moderate-to-severe Acute Respiratory Distress Syndrome: A Master Protocol","PEPER","Inclusion Criteria:\n\n* Invasive mechanical ventilation within 96 hours of ICU admission and within 72 hours of tracheal intubation for first randomization and then within 72 hours of the first randomization for the second randomization\n* Patients meeting the Berlin ARDS definition criteria with hypoxemia characterized as\n\n  * for first randomization: PaO2\u002FFiO2 ≤150 mmHg on a PEEP ≥5 cmH2O with FiO2≥0.6 while VT is 6 ml\u002Fkg Predicted Body Weight (PBW) and adequate sedation level to adjust mechanical ventilation settings\n  * for second randomization: PaO2\u002FFiO2 ≤150 mmHg on optimized ventilatory settings according to the first randomization, confirmed by two Arterial blood gas (ABG) analyses separated by an interval time of 4 hours and observed within 72 hours of the first randomization\n* Informed consent signed:\n\n  * by the patient\n  * Or informed consent signed by a family members\u002Ftrustworthy person if his condition does not allow him to express his consent by written as per L. 1111-6\n  * Or in a situation urgently and in the absence of family members\u002Ftrustworthy person, the patient can be enrolled. The consent to participate to the research will be requested as soon as the condition of the patient will allow him to consent.\n* Health insurance coverage\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Known pregnancy or breastfeeding\n* Participation in another interventional studies as long as these studies do not interfere with the primary endpoint and the secondary safety objectives of PEPER, or being in the exclusion period at the end of a previous study.\n* Intracranial pressure \\> 30 mm Hg or cerebral perfusion pressure \\\u003C 60 mmHg\n* Severe chronic respiratory disease requiring long-term O2 therapy or home mechanical ventilation (except Continuous positive arway pressure (CPAP)\u002F Bilevel positive airway pressure (BIPAP) used for sleep apnea syndrome)\n* Chronic interstitial lung disease\n* Continuous neuromuscular blockade infusion at enrolment\n* Previous hypersensitivity or anaphylactic reaction to any NMBA\n* Neuromuscular disease that may potentiate neuromuscular blockade or impair spontaneous ventilation: amyotrophic lateral sclerosis, Guillain-Barré syndrome, myasthenia gravis, upper spinal injury at level C5 or above\n* Patients on ECMO or any technique of extracorporeal CO2 removal\n* Sickle cell disease\n* Actual body weight \\>1 kg\u002Fcm of height\n* Severe chronic liver disease defined as a Child-Pugh score of 12-15\n* Pneumothorax at randomization\n* Expected duration of mechanical ventilation \\\u003C48 hours\n* Simplified acute physiology score SAPS II score \\>75 at the time of enrolment or suffering from a disease with an estimated survival time of less than two months\n* Decision to withhold life-sustaining treatment\n* Patients deprived of freedom or under legal authority\n* Unstable spine fracture",{"count":347,"type":21},1200,[59],"Despite best supportive care, mortality of the Acute Respiratory Distress Syndrom (ARDS) remains high. In the absence of specific treatments, providing safe and efficient mechanical ventilation (MV) is key to survival.\n\nThe use of low tidal volumes (VT) and plateau pressures (PPLAT) improves survival in randomized controlled trials (RCTs), but the safest VT to be applied for each patient remains unknown. Whether targeting low ∆P instead of a 6 mL\u002Fkg VT improves outcome has not been tested prospectively. The optimal method to set PEEP is also a matter of debate. As the amount of potentially recruitable lung vary widely among patients and is strongly associated with the response to PEEP, it may be necessary to tailor PEEP settings based on the response to a PEEP trial.\n\nThe first aim is to test a personalized approach to set PEEP widely supported by the literature. The first hypothesis is that i) patients with greater amounts of recruitable lung may benefit from higher PEEP levels, provided that attention is paid to maintain ∆P below 14 cmH2O, ii) setting PEEP based on results of a PEEP-responsiveness test improves survival as compared to low- and high-PEEP strategies applied independently of the patient response.\n\nApart from VT reduction and PPLAT control below 30 cmH2O, only 2 interventions demonstrated a reduction of mortality in large RCTs: a 48-hour continuous infusion of neuromuscular blocking agents (NMBAs) at the acute phase of ARDS6 and the use of prone positioning (PP). Whereas there is little doubt on the utility of PP in patients with PaO2\u002FFiO2 ratio \\\u003C 150 mmHg, there is more controversy on the impact of NMBAs on survival. Despite a strong rationale and a very widespread use in clinical practice, no current guidelines answer the question of the best timing of muscle relaxation in moderate to severe ARDS patients treated with PP.\n\nAs a second aim, the hypothesis is that the early systematic and combined use of NMBAs improved survival of patients with moderate to severe ARDS requiring prone positioning after optimization of PEEP settings.",[351,31],"Acute Respiratory Distress Syndrome (ARDS)","2025-02-25",{"date":354,"type":40},"2025-02-27",{"date":356,"type":21},"2025-04-01",{"date":358,"type":21},"2029-04-01",{"name":360,"class":47},"Assistance Publique - Hôpitaux de Paris"]