[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653610":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":41,"studyPopulation":41,"armGroups":49,"interventions":62,"overallOfficials":70,"centralContacts":74,"locations":79,"responsibleParty":156,"collaborators":159,"id":167,"slug":168,"hasResults":169,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":169,"sex":175,"minAge":176,"maxAge":41,"enrollmentInfo":177,"targetDuration":41,"studyType":180,"phases":181,"briefSummary":183,"conditions":184,"keywords":41,"overallStatus":186,"whyStopped":41,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":29,"otherOutcomes":41},[9,13,15,17,19,21,23,25,27],{"measure":10,"description":11,"timeFrame":12},"Safety assessed by the incidence of pre-specified AEs over the first 24 hours","Barotrauma","Maximum of 24 hours of VV",{"measure":10,"description":14,"timeFrame":12},"Worsening Hypoxemia",{"measure":10,"description":16,"timeFrame":12},"Worsening ventilation",{"measure":10,"description":18,"timeFrame":12},"New onset arrhythmia requiring cardioversion",{"measure":10,"description":20,"timeFrame":12},"Hemodynamic instability",{"measure":10,"description":22,"timeFrame":12},"ST-segment elevation myocardial infarction",{"measure":10,"description":24,"timeFrame":12},"Self-extubation",{"measure":10,"description":26,"timeFrame":12},"Stroke",{"measure":10,"description":28,"timeFrame":12},"Death",[30,34,37],{"measure":31,"description":32,"timeFrame":33},"Lung mechanics","Lung compliance, airways resistance, peak and plateau pressures","Every 12 hours to maximum of 24 hours of VV",{"measure":35,"description":36,"timeFrame":33},"Gas exchange","SpO2, PaO2\u002FFiO2 ratio, oxygenation index, dead space, and lung injury score.",{"measure":38,"description":39,"timeFrame":40},"Feasibility of VV implementation.","Qualitative feedback from Research and Clinical staff of the device and implementation in the ICU setting.","Every 12 hours during 24 hours of VV",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":45,"observationalModel":41,"timePerspective":41,"maskingInfo":46},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":47,"maskingDescription":48,"whoMasked":41},"NONE","No masking will be used in this study.",[50,56],{"label":51,"type":52,"description":53,"interventionNames":54},"Variable Ventilation","EXPERIMENTAL","Strategy of mechanical ventilation based on varying tidal volume breath to breath to provide therapeutic benefits in patients with ARDS. The variable ventilation (VV) strategy will be implemented on a commercially available ventilator.",[55],"Device: Variable Ventilation",{"label":57,"type":58,"description":59,"interventionNames":60},"Conventional Ventilation","PLACEBO_COMPARATOR","Standard strategy of mechanical ventilation based on constant size low tidal volume implemented on a commercially available ventilator.",[61],"Device: Conventional Ventilation",[63,67],{"type":64,"name":51,"description":65,"armGroupLabels":66,"otherNames":41},"DEVICE","Strategy of mechanical ventilation based on varying tidal volume breath to breath to provide therapeutic benefits in patients with ARDS.",[51],{"type":64,"name":57,"description":68,"armGroupLabels":69,"otherNames":41},"Strategy of mechanical ventilation based on delivery of a constant size low tidal volume.",[57],[71],{"name":72,"affiliation":5,"role":73},"Rebecca Baron, MD","PRINCIPAL_INVESTIGATOR",[75],{"name":72,"role":76,"phone":77,"phoneExt":41,"email":78},"CONTACT","617-525-6642","rbaron@bwh.harvard.edu",[80,97,111,129,139],{"facility":81,"status":41,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"University of Alabama at Birmingham","Birmingham","Alabama","35294","United States","US",{"type":88,"coordinates":89},"Point",[90,91],-86.80249,33.52066,{"lat":91,"lon":90},[94],{"name":95,"role":76,"phone":41,"phoneExt":41,"email":96},"Peter Morris, MD","pmorris@uabmc.edu",{"facility":98,"status":41,"city":99,"state":100,"zip":101,"country":85,"countryCode":86,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Baystate Health","Springfield","Massachusetts","01199",{"type":88,"coordinates":103},[104,105],-72.58981,42.10148,{"lat":105,"lon":104},[108],{"name":109,"role":76,"phone":41,"phoneExt":41,"email":110},"Mark Tidswell, MD","mark.tidswell@baystatehealth.org",{"facility":112,"status":41,"city":113,"state":114,"zip":115,"country":85,"countryCode":86,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Montefiore Einstein","The Bronx","New York","10461",{"type":88,"coordinates":117},[118,119],-73.86641,40.84985,{"lat":119,"lon":118},[122,126],{"name":123,"role":76,"phone":124,"phoneExt":41,"email":125},"Luke Andrea","314-705-0925","landrea@montefiore.org",{"name":127,"role":76,"phone":41,"phoneExt":41,"email":128},"Daniel Ceusters","dceuster@montefiore.org",{"facility":130,"status":41,"city":131,"state":132,"zip":133,"country":85,"countryCode":86,"cosmosGeoPoint":134,"geoPoint":138,"contacts":41},"Oregon Health & Science University","Portland","Oregon","97239-3098",{"type":88,"coordinates":135},[136,137],-122.67621,45.52345,{"lat":137,"lon":136},{"facility":140,"status":41,"city":141,"state":142,"zip":143,"country":85,"countryCode":86,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Intermountain Health Intermountain Medical Center","Murray","Utah","84107",{"type":88,"coordinates":145},[146,147],-111.88799,40.66689,{"lat":147,"lon":146},[150,153],{"name":151,"role":76,"phone":41,"phoneExt":41,"email":152},"Jessica Reimer","Jessica.Reimer@imail.org",{"name":154,"role":76,"phone":41,"phoneExt":41,"email":155},"Emma Murphy","Emma.Murphy@imail.org",{"type":73,"investigatorFullName":157,"investigatorTitle":158,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Rebecca Baron","Associate Professor of Medicine",[160,162,164,166],{"name":161,"class":6},"Baystate Medical Center",{"name":163,"class":6},"Boston University",{"name":165,"class":6},"Oregon Health and Science University",{"name":81,"class":6},"100653610","the-variable-ventilation-trial-part-a-100653610",false,"NCT07791225","The Variable Ventilation Trial (Part A)","A Bayesian, Operationally Seamless Adaptive Phase 2A\u002F2B, Open-label, Multi-center, Randomized, Two-part Trial to Evaluate the Safety, Efficacy, and Optimal Tidal Volume Distribution of Variable Ventilation (VV) in Participants Undergoing Mechanical Ventilatory Support for Acute Respiratory Distress Syndrome","VV (A)","Inclusion Criteria:\n\n1. Patients ≥21 years old admitted to the Surgical, Trauma, Burn, Coronary or Medical ICUs with ARDS according to the Berlin criteria \\[50\\] and requiring mechanical ventilation will be eligible for inclusion.\n2. Not more than 96 hours of mechanical ventilation before randomization\n3. Anticipated need for at least 48 more hours of controlled mechanical ventilation\n4. Intubated and mechanically ventilated for ARDS according to the Berlin criteria\n\n   * Hypoxemia of acute onset, within the past 7 days\n   * Mild or moderate hypoxemia, PaO2\u002FFiO2 ratio 100 - 300 mm Hg\n   * Presence of a risk factor for ARDS\n   * Respiratory failure not fully explained by cardiac failure or fluid overload\n   * Bilateral opacities not explained by effusions, lobar collapse, or nodules\n\nExclusion Criteria:\n\nDemographic\n\n1. Age less than 21 years\n2. Pregnant or breastfeeding\n3. Prisoner\n4. Concurrent participation in another investigational drug study\n5. Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if they would receive all supportive care except for attempts at resuscitation from cardiac arrest)\n6. No consent or inability to obtain consent or appropriate legal representative not available\n7. Physician refusal to allow enrollment in the trial\n8. Moribund patient not expected to survive 24 hours\n9. Treating team unwilling to use ARDS network low tidal volume strategy or variable ventilation mode\n10. Use, or planned use of ECMO\n11. Stroke (ischemic or hemorrhagic) or traumatic brain injury (TBI) within the prior 3 months\n12. Burns \\> 40% total body surface area (TBSA)\n13. Severe airway inhalational injury\n14. Diffuse alveolar hemorrhage\n15. Any of the following hallmarks of Severe COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) grade 3 or 4\n\n    1. FEV1 \\\u003C 50% predicted\n    2. Resting arterial blood gas values PaO2\\\u003C55, SaO2\\\u003C88%, or PaCO2\\>55\n    3. Home invasive or non-invasive ventilation other than for sleep apnea\n    4. Cor Pulmonale\n    5. Candidate for, or has received, lung volume reduction surgery, bronchoscopic intervention to reduce end-expiratory lung volume, or lung transplantation\n16. Any of the following cardiac problems:\n\n    1. Acute myocardial infarction (MI) or acute coronary syndrome within the last 90 days\n    2. Coronary artery bypass graft (CABG) surgery within 30 days\n    3. Angina pectoris, or use of nitrates, with activities of daily living\n    4. Cardiopulmonary disease classified as NYHA class IV\n\n    Physiological Exclusions\n17. Evidence of current barotrauma (e.g., pneumothorax, pneumomediastinum, or subcutaneous emphysema)\n18. Hemodynamic instability defined by inability to maintain a mean arterial pressure \\> 60 mm Hg.\n19. Other respiratory instability PEEP ≥18 cmH2O, suctioning more than hourly, Pplateau \\> 35 cm H2O, severe respiratory acidosis pH\\\u003C7.25.\n20. Increased ICP \\> 20 cmH2O or mechanism of injury leading to concern for increased ICP\n21. Active bleeding with hemodynamic instability.","ALL","21 Years",{"count":178,"type":179},20,"ESTIMATED","INTERVENTIONAL",[182],"NA","The goal of this clinical trial is to learn if a breathing machine (ventilator) method called \"variable ventilation\" can help protect the lungs of adult patients with acute respiratory distress syndrome (ARDS) who need help breathing through a ventilator. In variable ventilation, the size of each breath given by the machine changes slightly from breath to breath, instead of staying the same size in every breath. The study has two parts, A (safety and feasibility) and B (efficacy). This entry will cover the part A (safety study).\n\nThe main questions part A aims to answer are:\n\n1. Is variable ventilation safe to use in adults with ARDS?\n2. Is it feasible to deliver this method of ventilation to patients?\n\nResearchers will compare variable ventilation to the standard breathing machine method used today to see if variable ventilation is safe and feasible.\n\nParticipants will be placed on an FDA approved ventilator that can deliver conventional mechanical ventilation and variable ventilation. Participants will:\n\n* Have a period of stabilization on conventional ventilation, followed by 24 hours of variable ventilation, followed by 24 hours of conventional ventilation.\n* Be checked regularly for breathing, oxygen levels, lung function, and plasma biomarkers.",[185],"ARDS (Acute Respiratory Distress Syndrome)","NOT_YET_RECRUITING","2026-08-25",{"date":189,"type":190},"2026-08-27","ACTUAL",{"date":192,"type":179},"2027-02-01",{"date":194,"type":179},"2031-08-31",{"name":5,"class":6},5]