[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"respiratory-therapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:respiratory-therapy":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,89],{"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":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":88},"100172884","product-surveillance-registry-100172884","NCT01524276","Product Surveillance Registry","Medtronic Product Surveillance Registry","PSR","Inclusion Criteria:\n\n* Patient or legally authorized representative provides written authorization and\u002For consent per institution and geographical requirements\n* Patient has or is intended to receive or be treated with an eligible Medtronic product\n* Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment\n\nExclusion Criteria:\n\n* Patient who is, or will be, inaccessible for follow-up\n* Patient with exclusion criteria required by local law\n* Patient is currently enrolled in or plans to enroll in any concurrent drug and\u002For device study that may confound results",{"count":58,"type":21},100000,"OBSERVATIONAL","The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.",[62,63,64,65,66,67,68,30,69,70,71,72,73,74,75,76],"Cardiac Rhythm Disorders","Urological Disorders","Neurological Disorders","Cardiovascular Disorders","Digestive Disorders","Intracranial Aneurysm","Mechanical Circulatory Support","Aortic, Peripheral Vascular and Venous Disorders","Minimally Invasive Surgical Procedures","Diagnostic Techniques and Procedures","Surgical Procedures, Operative","Renal Insufficiency","Neurovascular","Coronary Artery Disease","Ear, Nose and Throat Disorder","RECRUITING","2026-06-15",{"date":80,"type":40},"2026-06-17",{"date":82,"type":4},"2012-01",{"date":84,"type":21},"2040-01",{"name":86,"class":87},"Medtronic","INDUSTRY",395,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":96,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":101,"conditions":102,"keywords":103,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":4},"100551523","computer-aided-respiratory-therapy-based-on-audio-and-spirometry-signals-100551523","NCT06461195","Computer Aided Respiratory Therapy Based on Audio and Spirometry Signals","COMPASS","Inclusion Criteria:\n\n* The patient has a chronic or acute respiratory condition and may need oxygen therapy\n* The patient is minimally 12 years old\n\nExclusion Criteria:\n\n* The patient is cognitively impaired.\n* The patient has an undrained pneumothorax.\n* The patient is experiencing an acute pulmonary hemorrhage.\n* The patient is having an asthma exacerbation.\n* The patient has an infection with Burkholderia cepatia.\n* The patient is in isolation due to the risk of infection.","12 Years",{"count":98,"type":21},15,[100],"NA","The purpose of the study is to collect data: audio in the form of respiratory sounds and instructions from the therapist, spirometry data during the execution of the therapy, physiological parameters, and patient information. With the help of this data, algorithms will be developed for the automatic detection, localization, and classification of respiratory sounds, linked to the respiratory cycle using spirometric signals.",[30],[104,105],"Spirometry","Respiratory sounds","2024-06-11",{"date":108,"type":40},"2024-06-14",{"date":110,"type":21},"2024-06-25",{"date":112,"type":21},"2025-09-30",{"name":114,"class":47},"Lieven De Maesschalck"]