[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spontaneous-breathing-trial\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spontaneous-breathing-trial":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,50,76,105,135,163],{"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":4,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100516838","diaphragmatic-speckle-tracking-during-spontaneous-breathing-trial-100516838",false,"NCT06009731","Diaphragmatic Speckle Tracking During Spontaneous Breathing Trial","DIAPHRAGMATIC SPECKLE TRACKING DURING SPONTANEOUS BREATHING TRIAL","DIAST","Inclusion Criteria:\n\n* Consecutive adult patients (≥18 years old) undergoing mechanical ventilation for at least 24h (regardless of the reason of intubation)\n* patients fulfilling criteria for an SBT\n* patients will have to be able to trigger ventilator breaths with a reasonable level of assistance,\n* patients with lack of severe impairment in gas exchange,\n* patients that not require significant hemodynamic support.\n* Patients will be recruited by the study coordinator following completion of informed consent from the patient or legally authorized substitute decision maker.\n\nExclusion Criteria:\n\n* Use of pressure support during the SBT.\n* Severe hemodynamic instability (\\>30% increase in vasopressors in the last 6 hours or norepinephrine \\> 0.5 µg\u002Fkg\u002Fmin).\n* Severe or very severe chronic obstructive pulmonary disease (COPD) according to the GOLD criteria (stage III: FEV1 30-50% predicted; stage IV: FEV1 \\\u003C 30% predicted).\n* Known or suspected severe or progressive neuromuscular disorder likely to result in prolonged or chronic ventilator dependence\n* Clinical judgement of the attending physician.","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","OBSERVATIONAL","Currently, measurement of transdiaphragmatic pressure (Pdi) using oesophageal and gastric balloons is the gold standard for the assessment of diaphragmatic effort. This technique is relatively invasive and its interpretation may be complex. The diaphragmatic longitudinal strain (LSdi) and strain rate (LSRdi) might provide additional information in the assessment of diaphragmatic effort and movement during SBT, allowing early detection of diaphragmatic dysfunction. Patients will be monitored during a 30-120 minutes SBT consisting of no assistance on the ventilator using CPAP with a pressure level of 0 cmH2O. Parameters to evaluate diaphragm function will include diaphragmatic strain (LSdi and LSRdi), diaphragmatic thickening fraction (TFdi), and airway occlusion pressure (ΔP0.1 and ΔPocc). These parameters will be measured immediately before ('baseline') the SBT, as well as 2 minutes ('early' assessment), 15 ('intermediate' assessment) and 30 minutes ('late' assessment) after the beginning of the SBT.",[25,26,27,28,29,30],"Weaning","Spontaneous Breathing Trial","Mechanical Ventilation","Speckle Tracking","Strains","Diaphragm",[32,33,34,35,29,36],"weaning","spontaneous breathing trial","mechanical ventilation","speckle tracking","diaphragm","RECRUITING","2026-05-12",{"date":40,"type":41},"2026-05-15","ACTUAL",{"date":43,"type":41},"2023-06-12",{"date":45,"type":21},"2027-07",{"name":47,"class":48},"Centre Hospitalier Universitaire, Amiens","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":59,"studyType":22,"phases":4,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":49},"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":20,"type":21},"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.",[62,63,64,27,26,65,66],"Critical Illness","Intensive Care Units (ICUs)","Weaning Failure","Diaphragm Electrical Activity","Oxygen Consumption","2025-11-20",{"date":69,"type":41},"2025-11-26",{"date":71,"type":41},"2025-07-08",{"date":73,"type":21},"2029-06",{"name":75,"class":48},"Leiden University Medical Center",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":49},"100605494","effectiveness-of-pet-robotic-intervention-in-intensive-care-unit-patients-100605494","NCT07163247","Effectiveness of Pet-Robotic Intervention in Intensive Care Unit Patients","Effectiveness of Using Pet-Robotic Intervention to Enhance Spontaneous Breathing Trial Success in Intensive Care Unit Patients","Inclusion Criteria:\n\n* Aged 18 years or older with clear consciousness.\n* Mechanical ventilation for more than 72 hours.\n* Previously failed the first spontaneous breathing trial and is clinically ready to undergo a second spontaneous breathing trial.\n\nExclusion Criteria:\n\n* Multidrug-resistant organism infection.\n* Requiring airborne infection isolation precautions (e.g., COVID-19).\n* Immunodeficiency (absolute neutrophil count \\\u003C 500 cells\u002FmL).\n* Richmond Agitation-Sedation Scale (RASS) less than -1.\n* Patient with a tracheostomy.\n* Subjects with implanted cardiac devices (e.g., permanent pacemaker, implantable cardioverter defibrillators)\n* Known allergy to the fur of the robotic pet.",{"count":84,"type":21},24,"INTERVENTIONAL",[87],"NA","This study aims to develop a novel nursing intervention involving robotic pet companionship to reduce anxiety in patients undergoing spontaneous breathing trials.",[90,26],"Spontaneous Breathing Trial in ICU",[92,93,94,95],"spontaneous breathing trials","Pet-robotic intervention","anxiety","Robot assisted intervention","2025-09-02",{"date":98,"type":41},"2025-09-09",{"date":100,"type":21},"2025-09",{"date":102,"type":21},"2026-01",{"name":104,"class":48},"National Taiwan University Hospital",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":85,"phases":115,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100587272","non-medicinal-technique-and-dyspnea-in-weaning-patients-100587272","NCT06926231","Non-medicinal Technique and Dyspnea in Weaning Patients","Impact of a Non-medicinal Technique Medical Hypnosis on Perceived Dyspnea in Difficult Ventilatory Weaning Patients: a Multicenter Randomized Controlled Trial.","Easy Wean","Inclusion Criteria:\n\n* Adult patient\n* hospitalized in the intensive care unit\n* receiving invasive mechanical ventilation for 24 hours or more.\n* who has failed at least one spontaneous breathing trial\n\nExclusion Criteria:\n\n* Patient already intubated during current ICU stay (including transfer from another ICU unit), with successful extubation during stay.\n* Tracheostomized patient or patient with a short-term tracheostomy project.\n* Patients with chronic neuromuscular pathologies (myopathy, amyotrophic lateral sclerosis, multi-system atrophy, non-exhaustive list).\n* Patient no longer eligible for SBT at time of inclusion (hemodynamic, neurological or respiratory criterion)\n* Psychiatric pathology identified in the medical record, diagnosed by a psychiatrist and for which medication is prescribed (bipolar disorder, schizophrenia, anxiety-depressive disorder, non-exhaustive list).\n* Recent brain injury, within \\\u003C 3 months (stroke, cardiopulmonary arrest with neurological prognosis, non-exhaustive list) objectivated by medical imagery.\n* Cognitive impairment or delirium associated with resuscitation, identified by a positive CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) test (dynamic parameter).\n* Ocular Glasgow score lower than 4\u002F4 and motor response lower than response to simple commands.\n* Delirium tremens with Cushman score \\> 7 (dynamic parameter).\n* Language barrier, patient who does not use French in everyday life.\n* Deaf or hearing-impaired patients.\n* Re-sedated patient following the failed SBT the day before inclusion.\n* Pregnant, parturient or breastfeeding women, objectified by a negative pregnancy test in women of childbearing age.\n* Patient for whom a limitation of therapeutics has been decided, including the absence of a re-intubation project.\n* Patient whose consent cannot be obtained (directly or in front of a relative or witness).\n* Patient already included in the same study or in another study sharing the same primary outcome.\n* Patient deprived of liberty by judicial or administrative decision.\n* Patient of legal age under legal protection (guardianship, curators).\n* Patient not affiliated to a social security system or beneficiary of a similar system.\n* Patient participating in another interventional research study with an exclusion period still in effect at pre-inclusion.",{"count":114,"type":21},82,[87],"This is a randomized, controlled, multicenter, open-label, category 2, parallel-arm study of efficacy and superiority.\n\nThe target population are patients hospitalized in the intensive care unit (ICU), ventilated with invasive mechanical ventilation for 24 hours or more and having failed a spontaneous breathing trial (SBT, i.e. weaning test of invasive mechanical ventilation \\[IMV\\]).\n\nThe primary objective is to evaluate the efficacy of medical hypnosis in reducing dyspnea experienced before the SBT in patients identified as difficult to wean in the ICU, compared with the protocolized standard of care.\n\nThe primary outcome is the mean value of the daily visual analog scale (VAS) of dyspnea, self-assessed by the patient, measured immediately after the hypnosis session (before SBT) from Day-0 to Day-7 or until extubation. In the control group, the daily value (from D0 to D7 or extubation) of the self-assessed dyspnea VAS will be measured immediately before SBT.\n\nThe protocol will be divided into two arms: a control arm in which standard of care practices regarding the daily SBT will be protocolized, and an interventional arm in which patients will receive protocolized medical hypnosis before the daily SBT in addition to the protocolized standard of care. The intervention (hypnosis or control) will be performed daily for 7 days (or until extubation, if applicable). The primary outcome will be assessed daily over the same period.",[118,26,119],"Difficult Mechanical Ventilation Weaning","Dyspnea",[121,122,34,33,123],"difficult mechanical ventilation weaning","dyspnea","hypnosis","NOT_YET_RECRUITING","2025-05-22",{"date":127,"type":41},"2025-05-23",{"date":129,"type":21},"2025-06-01",{"date":131,"type":21},"2027-06-01",{"name":133,"class":48},"Hospices Civils de Lyon",5,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":142,"maxAge":18,"enrollmentInfo":143,"targetDuration":4,"studyType":85,"phases":145,"briefSummary":146,"conditions":147,"keywords":151,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":49},"100561678","trial-of-spontaneous-breathing-test-100561678","NCT06593288","Trial of Spontaneous Breathing Test","Randomized Clinical Trial of Spontaneous Breathing Test","Inclusion Criteria:\n\n* Patients admitted to the PICU on MV for more than 24 hours\n* Patients over 1 month old (corrected gestational age \\> 38 weeks) and \\< 18 years old on the day of screening for ERT\n\nExclusion Criteria:\n\n* Perinatal-related lung disease\n* Congenital diaphragmatic hernia or congenital\u002Facquired paralysis of the diaphragm\n* Children with heart disease\n* Primary pulmonary hypertension\n* Bronchiolitis obliterans\n* Post-hematopoietic stem cell transplant; specifically, patients receiving continuous supplemental oxygen for three or more days prior to intubation; receiving noninvasive ventilation for more than 24 hours prior to intubation; receiving more than one vasoactive medication at the time of meeting the inclusion criteria; spending more than four days in the PICU prior to intubation; supported by or with immediate plans for renal replacement therapy; with two or more allogeneic transplants; who relapsed after transplant; or with diffuse alveolar hemorrhage\n* Post-lung transplantation\n* Home ventilator dependence with baseline Oxygen Saturation Index (OSI) \\>6 (baseline is defined as a stable period prior to the present illness)\n* Neuromuscular respiratory failure\n* Critical airway obstruction (e.g., post-laryngotracheal surgery or new tracheostomy) or anatomical lower airway obstruction (e.g., mediastinal mass)\n* Facial surgery or trauma in the past two weeks\n* Intracranial bleeding\n* Morbid obesity (2w-24mo: WHO weight-for-length z-score\u002Fheight z-score ≥+3; ≥2y: WHO body mass index (BMI)-for-age z-score ≥+3)\n* Family\u002Fmedical team unsupportive total (patient treatment considered futile)\n* Previously enrolled in a current study\n* Enrolled in any other clinical trial with intervention not approved for concomitant enrollment\n* Pregnancy","1 Month",{"count":144,"type":21},170,[87],"The hypothesis is that the Spontaneous Breathing Test (SBT) without pressure support (PS) is not inferior to the SBT with pressure support in relation to the following outcomes: a) extubation failure; b) time on MV.\n\nThe main objective of this study is to determine whether SBT without PS is non-inferior to SBT with PS in relation to the primary outcome: a) extubation failure; and secondary outcomes: b) length of stay in the PICU and c) days free of MV.\n\nPacients will be randomized to 2 arms:\n\n1. SBT with PS\n2. SBT without PS (with PEEP only)",[27,26,148,149,150],"Extubation Readiness","Extubation Failures","Pediatrics",[33,152,34,153],"extubation readiness test","pediatric intensive care","2024-12-03",{"date":156,"type":41},"2024-12-06",{"date":158,"type":21},"2025-03-10",{"date":160,"type":21},"2026-04",{"name":162,"class":48},"University of Sao Paulo",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":171,"targetDuration":59,"studyType":22,"phases":4,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":181,"locationsCount":182},"100546168","oxygen-consumption-vo2-effort-and-weaning-in-the-mechanically-ventilated-patient-in-the-intensive-care-unit-icu-100546168","NCT06391424","Oxygen Consumption (VO2), Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit (ICU)","Oxygen Consumption (VO2), Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit (ICU): EXTUBATE Study","EXTUBATE","Inclusion Criteria:\n\n* Age above 18 years\n* \\> 24 hours mechanically ventilated\n* Eligible for a spontaneous breathing trial according to the clinical team\n* Regular SBT (\"Regulier SBT\") according to the Leiden University Medical Center (LUMC) protocol\n* Hemodynamically stable\n* Esophageal Catheter in situ\n\nExclusion Criteria:\n\n* Severe chronic obstructive pulmonary disease (COPD) (Gold class IV) if it results in a non regular SBT according to the LUMC protocol.\n* Heart failure (LVEF \\\u003C30%) if it results in a non regular SBT according to the LUMC protocol\n* Known pregnancy",{"count":20,"type":21},"In patients who are mechanically ventilated for more than 72 hours weaning failure is a common issue. The Spontaneous breathing trial (SBT) is often done to assess if the patient can be extubated with a high chance of success. However, re-intubation rates are between 15 - 20 % after a successful SBT. The rapid shallow breathing index (RSBI) is an important parameter used in an SBT. Because the high incidence of extubation failure (re-intubation within 48 hours) a search for a better parameter than the RSBI is warranted. Using the measured end-tidal oxygen (etO2) of mechanically ventilated patients it is possible to calculate the VO2, which is a measure of patient effort. The VO2 is a parameter with the potential to predict weaning success or failure, together with other parameters of patient effort like the work of breathing (WOB), pressure time product (PTP) and esophageal pressure swings, reflecting muscle strength of the diaphragm. Therefore, the investigators want to investigate if these parameters are associated with an SBT success or failure.",[62,174,66,64,27,26],"Intensive Care Unit","2024-09-02",{"date":177,"type":41},"2024-09-19",{"date":179,"type":41},"2024-01-01",{"date":102,"type":21},{"name":75,"class":48},2]