[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100379527":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":59,"studyPopulation":11,"armGroups":60,"interventions":73,"overallOfficials":83,"centralContacts":88,"locations":96,"responsibleParty":124,"collaborators":11,"id":127,"slug":11,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":11,"eligibilityCriteria":132,"healthyVolunteers":128,"sex":133,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":11,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":98,"whyStopped":11,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Hospital Civil de Guadalajara","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Mechanical ventilation free days",null,"28 days",[14,16,18,21,25,28,30,32,34,36,38,41,43,45,47,49,51],{"measure":15,"description":11,"timeFrame":12},"All causes mortality",{"measure":17,"description":11,"timeFrame":12},"ICU length of stay",{"measure":19,"description":11,"timeFrame":20},"Hospital length of stay","60 days",{"measure":22,"description":23,"timeFrame":24},"Mean airway pressure, peak airway pressure, maximum P high","Measured in cmH20","7 days",{"measure":26,"description":27,"timeFrame":24},"Average expiratory time","Measured in seconds",{"measure":29,"description":11,"timeFrame":24},"Minute ventilation",{"measure":31,"description":11,"timeFrame":24},"oxygen partial pressure (pO2)",{"measure":33,"description":11,"timeFrame":24},"pCO2 (carbon dioxide partial pressure)",{"measure":35,"description":11,"timeFrame":24},"Mean arterial pressure",{"measure":37,"description":11,"timeFrame":24},"Maximum dosage of vasopressors requirement",{"measure":39,"description":40,"timeFrame":24},"Richmond Sedation-Agitation Scale","Range from -5 (unarousable) to +4 (combative)",{"measure":42,"description":11,"timeFrame":24},"Average dose of propofol use",{"measure":44,"description":11,"timeFrame":24},"Rate of neuromuscular blocking agents utilization",{"measure":46,"description":11,"timeFrame":24},"Prone position rate",{"measure":48,"description":11,"timeFrame":24},"Average of prone position sessions",{"measure":50,"description":11,"timeFrame":24},"Rate of recruitment maneuvers",{"measure":52,"description":11,"timeFrame":12},"Tracheostomy rate",{"allocation":54,"interventionModel":55,"interventionModelDescription":11,"primaryPurpose":56,"observationalModel":11,"timePerspective":11,"maskingInfo":57},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":58,"maskingDescription":11,"whoMasked":11},"NONE","Despite the advances in technology and ventilatory modes, mortality of ARDS is still around 40%. Besides prone positioning, the best approach of management is low tidal volume ventilation (LTV). This 'protective ventilation' strategy is not aways effective to improve oxygenation and is associated with an increased requirement of sedation and neuromuscular blocking agents, which increase length of stay and morbidity. APRV is a ventilatory mode based on relatively high and sustained continuous positive pressure, combined with a short phase of release to allow carbon dioxide removal. It also allows unrestricted spontaneous breathing throughout respiration, independent of the ventilator cycle. Providing sustained inflation while limiting duration and frequency of release phase permits limiting volume loss, resulting in progressive and improved alveolar recruitment, an increased alveolar surface area available for gas exchange and improved ventilation-perfusion matching.\n\nIn this multi-center, prospective, randomized, controlled, open trial, the investigators aim to compare the effects and safety of the early application of time-controlled adaptive method of APRV and conventional ventilation with LTV strategy in patients with severe to moderate ARDS.",[61,67],{"label":62,"type":63,"description":64,"interventionNames":65},"Conventional ventilation","ACTIVE_COMPARATOR","Protective lung conventional strategy with volume-controlled ventilation (VCV) or pressure-controlled ventilation (PCV) mode, with low tidal volume and adequate positive end expiratory pressure (PEEP) level.",[66],"Device: Conventional. General Electric Healthcare Engstrom ventilator system",{"label":68,"type":69,"description":70,"interventionNames":71},"Time-controlled adaptive APRV","EXPERIMENTAL","Airway Pressure Release Ventilation with Time-controlled adaptive ventilation method. Allowing for spontaneous breathing.",[72],"Device: APRV. General Electric Healthcare Engstrom ventilator system",[74,79],{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":11},"DEVICE","APRV. General Electric Healthcare Engstrom ventilator system","APRV consist of an extended time at plateau pressure (a continuous positive airway pressure phase) comprising about 90% of the respiratory cycle, while providing very brief releases to enhance carbon dioxide removal. Time-controlled adaptive method requires interpretation of the expiratory flow curve to assess changes in lung elastance and, therefore, set the Time low to optimize carbon dioxide removal, but not at the expense of alveolar derecruitment and instability.",[68],{"type":75,"name":80,"description":81,"armGroupLabels":82,"otherNames":11},"Conventional. General Electric Healthcare Engstrom ventilator system","Lung protective ventilation consist of delivery of low tidal volumes (4-6 ml\u002Fkg PBW), high PEEP enough to avoid de-recruitment, titrated according to ARDSNet PEEP\u002Ffraction of inspired oxygen (FiO2) table, while avoiding excessive transpulmonary pressure.",[62],[84],{"name":85,"affiliation":86,"role":87},"Miguel Ibarra-Estrada, Dr","Hospital Civil Fray Antonio Alcalde","PRINCIPAL_INVESTIGATOR",[89,93],{"name":85,"role":90,"phone":91,"phoneExt":11,"email":92},"CONTACT","3317593502","drmiguelibarra@hotmail.com",{"name":94,"role":90,"phone":11,"phoneExt":11,"email":95},"Guadalupe Aguirre-Avalos, Dr","guadalupe.aavalos@academicos.udg.mx",[97],{"facility":86,"status":98,"city":99,"state":100,"zip":101,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":109,"contacts":110},"RECRUITING","Guadalajara","Jalisco","44280","Mexico","MX",{"type":105,"coordinates":106},"Point",[107,108],-103.34749,20.67738,{"lat":108,"lon":107},[111,113,115,118,120,122],{"name":112,"role":90,"phone":91,"phoneExt":11,"email":92},"Miguel Ibarra, Dr",{"name":114,"role":90,"phone":11,"phoneExt":11,"email":95},"Guadalupe Aguirre, Dr",{"name":116,"role":117,"phone":11,"phoneExt":11,"email":11},"Guadalupe Aguirre-Avalos, MD","SUB_INVESTIGATOR",{"name":119,"role":117,"phone":11,"phoneExt":11,"email":11},"Yessica García-Salas, MD",{"name":121,"role":117,"phone":11,"phoneExt":11,"email":11},"Quetzalcóatl Chávez-Peña, MD",{"name":123,"role":117,"phone":11,"phoneExt":11,"email":11},"Arnulfo López-Pulgarín, MD",{"type":87,"investigatorFullName":125,"investigatorTitle":126,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Miguel Á Ibarra-Estrada","Principal investigator","100379527",false,"NCT04221737","Early Use of Airway Pressure Release Ventilation (APRV) in ARDS","Early Use of Airway Pressure Release Ventilation (APRV) in Patients With Acute Respiratory Distress Syndrome","Inclusion Criteria:\n\n* Acute respiratory distress syndrome, according to the Berlin definition of ARDS, with adjusted pO2\u002FFiO2 for altitude \\\u003C300, and less than 48 h of endotracheal mechanical ventilation\n\nExclusion Criteria:\n\n* Pregnancy\n* Less than 18 years-old\n* Expected duration of mechanical ventilation less than 48 h\n* Preexisting conditions with an expected 3-month mortality exceeding 50%\n* Concurrent chemotherapy\n* Confirmed intracranial hypertension\n* Catastrophic cranial trauma or neuromuscular disorders that are known to prolong mechanical ventilation\n* Pneumothorax at enrollment (resolved or not)\n* Do-not-resuscitate order","ALL","18 Years","80 Years",{"count":137,"type":138},150,"ESTIMATED","INTERVENTIONAL",[141],"NA","Airway pressure release ventilation (APRV) is a time-cycled, pressure controlled, intermittent mandatory ventilation mode with extreme inverse I:E ratios. Currently it is considered as a non-conventional ventilatory mode. The investigators aim to compare APRV with conventional mechanical ventilation (MV) in patients with acute respiratory distress syndrome (ARDS).",[144],"Acute Respiratory Distress Syndrome",[144,146,147,148],"Acute Lung Injury","Mechanical Ventilation","APRV","2025-03-15",{"date":151,"type":152},"2025-03-19","ACTUAL",{"date":154,"type":152},"2017-07-15",{"date":156,"type":138},"2026-01",{"name":5,"class":6},1]