[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"extubation-failures\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:extubation-failures":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100561678","trial-of-spontaneous-breathing-test-100561678",false,"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","ALL","1 Month","18 Years",{"count":20,"type":21},170,"ESTIMATED","INTERVENTIONAL",[24],"NA","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)",[27,28,29,30,31],"Mechanical Ventilation","Spontaneous Breathing Trial","Extubation Readiness","Extubation Failures","Pediatrics",[33,34,35,36],"spontaneous breathing trial","extubation readiness test","mechanical ventilation","pediatric intensive care","NOT_YET_RECRUITING","2024-12-03",{"date":40,"type":41},"2024-12-06","ACTUAL",{"date":43,"type":21},"2025-03-10",{"date":45,"type":21},"2026-04",{"name":47,"class":48},"University of Sao Paulo","OTHER"]