[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561678":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":32,"locations":41,"responsibleParty":62,"collaborators":23,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":23,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":23,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":88,"overallStatus":93,"whyStopped":23,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of Sao Paulo","OTHER",[8,13],{"label":9,"type":10,"description":9,"interventionNames":11},"Spontaneous breathing trial with pressure support","ACTIVE_COMPARATOR",[12],"Other: Pressure Support Ventilation",{"label":14,"type":10,"description":15,"interventionNames":16},"Spontaneous breathing trial without pressure support","Spontaneous breathing trial without pressure support ( CPAP)",[17],"Other: continuous positive airway pressure (CPAP)",[19,24],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Pressure Support Ventilation","Conduct the Spontaneous breathing trial with pressure support",[9],null,{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"continuous positive airway pressure (CPAP)","Conduct the spontaneous breathing trial with CPAP",[14],[29],{"name":30,"affiliation":5,"role":31},"Ana Paula C Carlotti, MD, PhD","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":23,"email":37},"José Colleti Junior, MD, PhD","CONTACT","+5511942683834","colleti@gmail.com",{"name":30,"role":35,"phone":39,"phoneExt":23,"email":40},"+5516997045414","apcarlotti@fmrp.usp.br",[42],{"facility":43,"status":23,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo","Ribeirão Preto","São Paulo","14015-010","Brazil","BR",{"type":50,"coordinates":51},"Point",[52,53],-47.81028,-21.1775,{"lat":53,"lon":52},[56,58,59,60],{"name":57,"role":35,"phone":39,"phoneExt":23,"email":40},"Ana Paula C P Carlotti, MD, PhD",{"name":23,"role":35,"phone":23,"phoneExt":23,"email":37},{"name":30,"role":35,"phone":23,"phoneExt":23,"email":23},{"name":61,"role":35,"phone":23,"phoneExt":23,"email":23},"Jose Colleti Junior, MD, PhD",{"type":31,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Ana Carlotti","Faculty of Medicine of Ribeirao Preto, University of Sao Paulo","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":76,"type":77},170,"ESTIMATED","INTERVENTIONAL",[80],"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)",[83,84,85,86,87],"Mechanical Ventilation","Spontaneous Breathing Trial","Extubation Readiness","Extubation Failures","Pediatrics",[89,90,91,92],"spontaneous breathing trial","extubation readiness test","mechanical ventilation","pediatric intensive care","NOT_YET_RECRUITING","2024-12-03",{"date":96,"type":97},"2024-12-06","ACTUAL",{"date":99,"type":77},"2025-03-10",{"date":101,"type":77},"2026-04",{"name":5,"class":6},1]