[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521200":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":43,"responsibleParty":550,"collaborators":553,"id":560,"slug":561,"hasResults":562,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":566,"eligibilityCriteria":567,"healthyVolunteers":562,"sex":568,"minAge":569,"maxAge":24,"enrollmentInfo":570,"targetDuration":24,"studyType":573,"phases":574,"briefSummary":576,"conditions":577,"keywords":580,"overallStatus":46,"whyStopped":24,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":596},{"fullName":5,"class":6},"Beth Israel Deaconess Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Precision ventilation","EXPERIMENTAL","Ventilator support will be calibrated to maintain the range of lung stress typical of relaxed breathing in healthy adults. The ventilator management protocol takes into account pleural pressure, tidal volume and driving pressure, fraction of inspired oxygen (FiO2) and oxygen saturation (SpO2), and positive end-expiratory pressure (PEEP) titration.",[13],"Other: Precision ventilation",{"label":15,"type":16,"description":17,"interventionNames":18},"Guided usual care","ACTIVE_COMPARATOR","Ventilator support will be managed by the clinical team per usual care with select protocol-based guard rails to avoid practice extremes beyond the current body of evidence. PEEP titration will be performed by the clinical team within the limits set in. The allowable combinations of PEEP and FiO2 in the control arm reflect pre-intervention usual care observed at baseline in the recent large federally-funded multicenter ARDS trials.",[19],"Other: Guided usual care ventilation",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"The intervention arm prioritizes mitigation of ventilator-induced-lung-injury by individualizing support to patient-specific mechanics in an integrated approach to limit overdistension and atelectrauma. This is accomplished in this arm by titration of tidal volume to limitation of driving pressure at 12 centimeters of water (cmH2O) or less and using esophageal manometry to titrate PEEP to a transpulmonary pressure of 0 cmH2O with adjustments in respiratory rate to allow for permissive hypercapnia and FiO2 adjustments to assure adequate oxygenation.",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Guided usual care ventilation","The comparison arm allows clinician discretion when titrating PEEP and tidal volume, while setting general targets for allowable PEEP\u002FFiO2 combinations, target range for SpO2, and target range for tidal volume. This arm applies routine best-practice guidelines. This includes maintenance of tidal volumes of 6-8 cc\u002Fkg of ideal body weight, limiting plateau pressures to 30 cmH2O or less and application of PEEP-FiO2 combinations which include a wide range of typical usual care with esophageal manometry only for data collection and not clinical adjustment.",[15],[30],{"name":31,"affiliation":5,"role":32},"Daniel Talmor, MD MPH","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Valerie Goodspeed, MPH","CONTACT","6176328055","vgoodspe@bidmc.harvad.edu",{"name":40,"role":36,"phone":41,"phoneExt":24,"email":42},"Nancy Ringwood, RN","617-724-9836","nringwood@mgh.harvard.edu",[44,65,82,99,115,128,144,155,172,190,207,224,237,250,262,276,293,307,322,333,346,360,376,393,406,419,436,453,467,483,500,516,533],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"University of Arizona","RECRUITING","Tucson","Arizona","85724","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-110.92648,32.22174,{"lat":56,"lon":55},[59,62],{"name":60,"role":36,"phone":24,"phoneExt":24,"email":61},"Jarrod M Mosier, MD","jmosier@arizona.edu",{"name":63,"role":36,"phone":24,"phoneExt":24,"email":64},"Beth S Campbell, PhD","bsalvag@arizona.edu",{"facility":66,"status":46,"city":67,"state":68,"zip":69,"country":50,"countryCode":51,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"University of Arkansas for Medical Sciences","Little Rock","Arkansas","72205",{"type":53,"coordinates":71},[72,73],-92.28959,34.74648,{"lat":73,"lon":72},[76,79],{"name":77,"role":36,"phone":24,"phoneExt":24,"email":78},"Harmeen Goraya, MD","HGoraya@uams.edu",{"name":80,"role":36,"phone":24,"phoneExt":24,"email":81},"Brandy Lee","BLee4@uams.edu",{"facility":83,"status":46,"city":84,"state":85,"zip":86,"country":50,"countryCode":51,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"University of California, San Diego","La Jolla","California","92093",{"type":53,"coordinates":88},[89,90],-117.2742,32.84727,{"lat":90,"lon":89},[93,96],{"name":94,"role":36,"phone":24,"phoneExt":24,"email":95},"Robert Owens, MD","rowens@health.ucsd.edu",{"name":97,"role":36,"phone":24,"phoneExt":24,"email":98},"Pamela N Deyoung","pdeyoung@health.ucsd.edu",{"facility":100,"status":46,"city":101,"state":85,"zip":102,"country":50,"countryCode":51,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"University of California, Los Angeles Medical Center","Los Angeles","90024",{"type":53,"coordinates":104},[105,106],-118.24368,34.05223,{"lat":106,"lon":105},[109,112],{"name":110,"role":36,"phone":24,"phoneExt":24,"email":111},"Steven Y Chang, MD","sychang@mednet.ucla.edu",{"name":113,"role":36,"phone":24,"phoneExt":24,"email":114},"Julia Vargas","JuliaVargas@mednet.ucla.edu",{"facility":116,"status":46,"city":101,"state":85,"zip":117,"country":50,"countryCode":51,"cosmosGeoPoint":118,"geoPoint":120,"contacts":121},"Cedar-Sinai Medical Center","90048",{"type":53,"coordinates":119},[105,106],{"lat":106,"lon":105},[122,125],{"name":123,"role":36,"phone":24,"phoneExt":24,"email":124},"Abirami Kumaresan, MD","Abirami.Kumaresan@cshs.org",{"name":126,"role":36,"phone":24,"phoneExt":24,"email":127},"Janice Emmanuella, DO","janice.emmanuella@cshs.org",{"facility":129,"status":46,"city":130,"state":85,"zip":131,"country":50,"countryCode":51,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Stanford University","Palo Alto","94305",{"type":53,"coordinates":133},[134,135],-122.14302,37.44188,{"lat":135,"lon":134},[138,141],{"name":139,"role":36,"phone":24,"phoneExt":24,"email":140},"Joseph Levitt, MD","jlevitt@stanford.edu",{"name":142,"role":36,"phone":24,"phoneExt":24,"email":143},"Rosemary Vojnik","rvojnik@stanford.edu",{"facility":145,"status":46,"city":146,"state":85,"zip":147,"country":50,"countryCode":51,"cosmosGeoPoint":24,"geoPoint":24,"contacts":148},"University of California, San Francisco","San Franciso","94143",[149,152],{"name":150,"role":36,"phone":24,"phoneExt":24,"email":151},"Michael Matthay, MD","Michael.Matthay@ucsf.edu",{"name":153,"role":36,"phone":24,"phoneExt":24,"email":154},"Hanjing Zhou, MPH","hanjing.zhuo@ucsf.edu",{"facility":156,"status":46,"city":157,"state":158,"zip":159,"country":50,"countryCode":51,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"University of Miami","Miami","Florida","33136",{"type":53,"coordinates":161},[162,163],-80.19366,25.77427,{"lat":163,"lon":162},[166,169],{"name":167,"role":36,"phone":24,"phoneExt":24,"email":168},"Alexander Fort, MD","acfort@med.miami.edu",{"name":170,"role":36,"phone":24,"phoneExt":24,"email":171},"Alessandro Colantuono Esaa","adc135@med.miami.edu",{"facility":173,"status":174,"city":175,"state":176,"zip":177,"country":50,"countryCode":51,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Emory University \u002F Grady Health System","NOT_YET_RECRUITING","Atlanta","Georgia","30322",{"type":53,"coordinates":179},[180,181],-84.38798,33.749,{"lat":181,"lon":180},[184,187],{"name":185,"role":36,"phone":24,"phoneExt":24,"email":186},"Matthew R Thau, MD","matthew.ryan.thau@emory.edu",{"name":188,"role":36,"phone":24,"phoneExt":24,"email":189},"Vidhi Javia","vidhi.javia@emory.edu",{"facility":191,"status":46,"city":192,"state":193,"zip":194,"country":50,"countryCode":51,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"University of Chicago","Chicago","Illinois","60637",{"type":53,"coordinates":196},[197,198],-87.65005,41.85003,{"lat":198,"lon":197},[201,204],{"name":202,"role":36,"phone":24,"phoneExt":24,"email":203},"Bhakti Patel, MD","bpatel@bsd.uchicago.edu",{"name":205,"role":36,"phone":24,"phoneExt":24,"email":206},"Tasneem Tweel","tasneem.tweel@bsd.uchicago.edu",{"facility":208,"status":46,"city":209,"state":210,"zip":211,"country":50,"countryCode":51,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Tufts Medical Center","Boston","Massachusetts","02111",{"type":53,"coordinates":213},[214,215],-71.05977,42.35843,{"lat":215,"lon":214},[218,221],{"name":219,"role":36,"phone":24,"phoneExt":24,"email":220},"Anthony Faugno, MD","Anthony.Faugno1@tuftsmedicine.org",{"name":222,"role":36,"phone":24,"phoneExt":24,"email":223},"Bipin Malla","Bipin.Malla@tuftsmedicine.org",{"facility":225,"status":46,"city":209,"state":210,"zip":226,"country":50,"countryCode":51,"cosmosGeoPoint":227,"geoPoint":229,"contacts":230},"Massachusetts General Hospital","02114",{"type":53,"coordinates":228},[214,215],{"lat":215,"lon":214},[231,234],{"name":232,"role":36,"phone":24,"phoneExt":24,"email":233},"Lorenzo Berra, MD","lberra@mgh.harvard.edu",{"name":235,"role":36,"phone":24,"phoneExt":24,"email":236},"Cristina Mietto, MD","cmietto@mgh.harvard.edu",{"facility":238,"status":46,"city":209,"state":210,"zip":239,"country":50,"countryCode":51,"cosmosGeoPoint":240,"geoPoint":242,"contacts":243},"Brigham and Women's Hospital","02115",{"type":53,"coordinates":241},[214,215],{"lat":215,"lon":214},[244,247],{"name":245,"role":36,"phone":24,"phoneExt":24,"email":246},"Jakob Wollborn, MD, PhD","jwollborn@bwh.harvard.edu",{"name":248,"role":36,"phone":24,"phoneExt":24,"email":249},"Tayisha Examond","texamond@bwh.harvard.edu",{"facility":5,"status":46,"city":209,"state":210,"zip":251,"country":50,"countryCode":51,"cosmosGeoPoint":252,"geoPoint":254,"contacts":255},"02215",{"type":53,"coordinates":253},[214,215],{"lat":215,"lon":214},[256,259],{"name":35,"role":36,"phone":257,"phoneExt":24,"email":258},"617-632-8055","vgoodspe@bidmc.harvard.edu",{"name":31,"role":36,"phone":260,"phoneExt":24,"email":261},"617-667-2902","dtalmor@bidmc.harvard.edu",{"facility":263,"status":174,"city":264,"state":210,"zip":265,"country":50,"countryCode":51,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"Lowell General Hospital","Lowell","01854",{"type":53,"coordinates":267},[268,269],-71.31617,42.63342,{"lat":269,"lon":268},[272,274],{"name":219,"role":36,"phone":24,"phoneExt":24,"email":273},"anthony.faugno1@tuftsmedicine.org",{"name":222,"role":36,"phone":24,"phoneExt":24,"email":275},"bipin.malla@tuftsmedicine.org",{"facility":277,"status":46,"city":278,"state":279,"zip":280,"country":50,"countryCode":51,"cosmosGeoPoint":281,"geoPoint":285,"contacts":286},"University of Michigan","Ann Arbor","Michigan","48109",{"type":53,"coordinates":282},[283,284],-83.74088,42.27756,{"lat":284,"lon":283},[287,290],{"name":288,"role":36,"phone":24,"phoneExt":24,"email":289},"Pauline K Park, MD","parkpk@med.umich.edu",{"name":291,"role":36,"phone":24,"phoneExt":24,"email":292},"Norman Olbrich","onorman@med.umich.edu",{"facility":294,"status":46,"city":295,"state":296,"zip":297,"country":50,"countryCode":51,"cosmosGeoPoint":298,"geoPoint":302,"contacts":303},"Mayo Clinic","Rochester","Minnesota","55905",{"type":53,"coordinates":299},[300,301],-92.4699,44.02163,{"lat":301,"lon":300},[304],{"name":305,"role":36,"phone":24,"phoneExt":24,"email":306},"Gustavo Cortes Puentes, MD","CortesPuentes.Gustavo@mayo.edu",{"facility":308,"status":46,"city":309,"state":309,"zip":226,"country":50,"countryCode":51,"cosmosGeoPoint":310,"geoPoint":314,"contacts":315},"NYU Lagone Health","New York",{"type":53,"coordinates":311},[312,313],-74.00597,40.71427,{"lat":313,"lon":312},[316,319],{"name":317,"role":36,"phone":24,"phoneExt":24,"email":318},"Jeremy Beitler, MD MPH","Jeremy.Beitler@nyulangone.org",{"name":320,"role":36,"phone":24,"phoneExt":24,"email":321},"Alexis Serra, MD MPH","dl_aspire@nyulangone.org",{"facility":323,"status":46,"city":309,"state":309,"zip":324,"country":50,"countryCode":51,"cosmosGeoPoint":325,"geoPoint":327,"contacts":328},"New York City Health + Hospitals\u002F Bellevue","10016",{"type":53,"coordinates":326},[312,313],{"lat":313,"lon":312},[329,332],{"name":330,"role":36,"phone":24,"phoneExt":24,"email":331},"Jeremy Beitler, MD","jeremy.beitler@nyulangone.org",{"name":24,"role":36,"phone":24,"phoneExt":24,"email":321},{"facility":334,"status":46,"city":335,"state":309,"zip":336,"country":50,"countryCode":51,"cosmosGeoPoint":337,"geoPoint":341,"contacts":342},"Albert Einstein College of Medicine\u002FMontefiore Medical Center","The Bronx","10461",{"type":53,"coordinates":338},[339,340],-73.86641,40.84985,{"lat":340,"lon":339},[343],{"name":344,"role":36,"phone":24,"phoneExt":24,"email":345},"Ari L Moskowitz, MD MPH","amoskowitz@montefiore.org",{"facility":347,"status":46,"city":348,"state":349,"zip":350,"country":50,"countryCode":51,"cosmosGeoPoint":351,"geoPoint":355,"contacts":356},"Duke University Medical Center","Durham","North Carolina","27710",{"type":53,"coordinates":352},[353,354],-78.89862,35.99403,{"lat":354,"lon":353},[357],{"name":358,"role":36,"phone":24,"phoneExt":24,"email":359},"Christina Barkauskas, MD","christina.barkauskas@duke.edu",{"facility":361,"status":46,"city":362,"state":349,"zip":363,"country":50,"countryCode":51,"cosmosGeoPoint":364,"geoPoint":368,"contacts":369},"Atrium Health Wake Forest Baptist","Winston-Salem","27157",{"type":53,"coordinates":365},[366,367],-80.24422,36.09986,{"lat":367,"lon":366},[370,373],{"name":371,"role":36,"phone":24,"phoneExt":24,"email":372},"Kevin Gibbs, MD","kevin.gibbs@wfusm.edu",{"name":374,"role":36,"phone":24,"phoneExt":24,"email":375},"Darija Ward, MBA","darija.runjaicward@advocatehealth.org",{"facility":377,"status":46,"city":378,"state":379,"zip":380,"country":50,"countryCode":51,"cosmosGeoPoint":381,"geoPoint":385,"contacts":386},"University of Cincinnati","Cincinnati","Ohio","45267",{"type":53,"coordinates":382},[383,384],-84.51439,39.12711,{"lat":384,"lon":383},[387,390],{"name":388,"role":36,"phone":24,"phoneExt":24,"email":389},"Kristin Hudock, MD","hudockkn@ucmail.uc.edu",{"name":391,"role":36,"phone":24,"phoneExt":24,"email":392},"Robert D Hite, MD","hitern@ucmail.uc.edu",{"facility":394,"status":46,"city":395,"state":379,"zip":396,"country":50,"countryCode":51,"cosmosGeoPoint":397,"geoPoint":401,"contacts":402},"Cleveland Clinic Foundation","Cleveland","44195",{"type":53,"coordinates":398},[399,400],-81.69541,41.4995,{"lat":400,"lon":399},[403],{"name":404,"role":36,"phone":24,"phoneExt":24,"email":405},"Eduardo Mireles-Cabodevila, MD","mirelee@ccf.org",{"facility":407,"status":46,"city":408,"state":379,"zip":409,"country":50,"countryCode":51,"cosmosGeoPoint":410,"geoPoint":414,"contacts":415},"Ohio State University Wexner Medical Center","Columbus","43210",{"type":53,"coordinates":411},[412,413],-82.99879,39.96118,{"lat":413,"lon":412},[416],{"name":417,"role":36,"phone":24,"phoneExt":24,"email":418},"Joshua A Englert, MD","Joshua.Englert@osumc.edu",{"facility":420,"status":174,"city":421,"state":422,"zip":423,"country":50,"countryCode":51,"cosmosGeoPoint":424,"geoPoint":428,"contacts":429},"University of Oklahoma Health Sciences","Oklahoma City","Oklahoma","73104",{"type":53,"coordinates":425},[426,427],-97.51643,35.46756,{"lat":427,"lon":426},[430,433],{"name":431,"role":36,"phone":24,"phoneExt":24,"email":432},"Huimin Wu, MD","Huimin-Wu@ou.edu",{"name":434,"role":36,"phone":24,"phoneExt":24,"email":435},"Blair Apple Hill","Blair-AppleHill@ouhsc.edu",{"facility":437,"status":46,"city":438,"state":439,"zip":440,"country":50,"countryCode":51,"cosmosGeoPoint":441,"geoPoint":445,"contacts":446},"Oregon Health & Science University","Portland","Oregon","97239",{"type":53,"coordinates":442},[443,444],-122.67621,45.52345,{"lat":444,"lon":443},[447,450],{"name":448,"role":36,"phone":24,"phoneExt":24,"email":449},"Akram Khan, MD","khana@ohsu.edu",{"name":451,"role":36,"phone":24,"phoneExt":24,"email":452},"Jose Pena, MD","penaj@ohsu.edu",{"facility":454,"status":46,"city":455,"state":456,"zip":457,"country":50,"countryCode":51,"cosmosGeoPoint":458,"geoPoint":462,"contacts":463},"Thomas Jefferson University","Philadelphia","Pennsylvania","19107",{"type":53,"coordinates":459},[460,461],-75.16362,39.95238,{"lat":461,"lon":460},[464],{"name":465,"role":36,"phone":24,"phoneExt":24,"email":466},"Michael Baram, MD","Michael.Baram@jefferson.edu",{"facility":468,"status":46,"city":469,"state":470,"zip":471,"country":50,"countryCode":51,"cosmosGeoPoint":472,"geoPoint":476,"contacts":477},"Baylor College of Medicine \u002F St. Luke's Medical Center","Houston","Texas","77030",{"type":53,"coordinates":473},[474,475],-95.36327,29.76328,{"lat":475,"lon":474},[478,481],{"name":479,"role":36,"phone":24,"phoneExt":24,"email":480},"Christopher Howard, MD","christopher.howard@bcm.edu",{"name":24,"role":36,"phone":24,"phoneExt":24,"email":482},"cru_pulmonary@bcm.edu",{"facility":484,"status":46,"city":485,"state":486,"zip":487,"country":50,"countryCode":51,"cosmosGeoPoint":488,"geoPoint":492,"contacts":493},"Intermountain Health","Murray","Utah","84107",{"type":53,"coordinates":489},[490,491],-111.88799,40.66689,{"lat":491,"lon":490},[494,497],{"name":495,"role":36,"phone":24,"phoneExt":24,"email":496},"Jennifer Edwards, MD","Jennifer.Edwards@imail.org",{"name":498,"role":36,"phone":24,"phoneExt":24,"email":499},"Sarah Duckworth","Sarah.Duckworth@imail.org",{"facility":501,"status":46,"city":502,"state":486,"zip":503,"country":50,"countryCode":51,"cosmosGeoPoint":504,"geoPoint":508,"contacts":509},"University of Utah","Salt Lake City","84132",{"type":53,"coordinates":505},[506,507],-111.89105,40.76078,{"lat":507,"lon":506},[510,513],{"name":511,"role":36,"phone":24,"phoneExt":24,"email":512},"Andrew Freeman, MD","Andrew.Freeman@hsc.utah.ed",{"name":514,"role":36,"phone":24,"phoneExt":24,"email":515},"Lindsey Waddoups, MS","lindsey.Waddoups@hsc.utah.edu",{"facility":517,"status":46,"city":518,"state":519,"zip":520,"country":50,"countryCode":51,"cosmosGeoPoint":521,"geoPoint":525,"contacts":526},"University of Virginia","Charlottesville","Virginia","22908",{"type":53,"coordinates":522},[523,524],-78.47668,38.02931,{"lat":524,"lon":523},[527,530],{"name":528,"role":36,"phone":24,"phoneExt":24,"email":529},"Danny Theodore, MD","dt7sj@uvahealth.org",{"name":531,"role":36,"phone":24,"phoneExt":24,"email":532},"Jennifer Phillips","jvp8a@uvahealth.org",{"facility":534,"status":46,"city":535,"state":536,"zip":537,"country":50,"countryCode":51,"cosmosGeoPoint":538,"geoPoint":542,"contacts":543},"University of Washingont\u002FHarborview Medical Center","Seattle","Washington","98104",{"type":53,"coordinates":539},[540,541],-122.33207,47.60621,{"lat":541,"lon":540},[544,547],{"name":545,"role":36,"phone":24,"phoneExt":24,"email":546},"Nicholas J Johnson, MD","nickj45@uw.edu",{"name":548,"role":36,"phone":24,"phoneExt":24,"email":549},"Frances Nagore","francesn@uw.edu",{"type":32,"investigatorFullName":551,"investigatorTitle":552,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Daniel Talmor","Professor and Chair of Anaesthesia",[554,556,557],{"name":555,"class":6},"NYU Langone Health",{"name":225,"class":6},{"name":558,"class":559},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100521200","phase-3-precision-ventilation-vs-standard-care-for-acute-respiratory-distress-syndrome-100521200",false,"NCT06066502","Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome","PREcision VENTilation to Attenuate Ventilator-Induced Lung Injury: A Phase 3 Multicenter Randomized Clinical Trial","PREVENT VILI","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Ventilator-dependent ARDS, with all of the following (a-e):\n\n   1. Invasive ventilation with positive end-expiratory pressure (PEEP) ≥ 8 cm H2O or FiO2 ≥ 0.5\n   2. Hypoxemia as characterized by: • If arterial blood gas (ABG) available: the partial pressure of oxygen in the arterial blood (PaO2)\u002FFiO2 ≤ 300 mm Hg, or, • if ABG not available OR overt clinical deterioration in oxygenation since last ABG: SpO2\u002FFiO2 ≤ 316 with SpO2 ≤ 97% (both conditions) on two representative assessments between 1 to 6 hours apart. • If patient is positioned prone or receiving inhaled pulmonary vasodilator at time of screening:\n\n      Qualifying PaO2\u002FFiO2 or SpO2\u002FFiO2 (as defined above) that was recorded within the 6 hours immediately prior to initiating either of these therapies may be used for eligibility determination. • If PEEP has been increased by \\> 5 cm H2O within the last 12 hours immediately prior to screening:\n\n      Qualifying PaO2\u002FFiO2 or SpO2\u002FFiO2 (as defined above) prior to PEEP increase may be used for eligibility determination if recorded within this 12-hour window.\n   3. Bilateral lung opacities on chest imaging not fully explained by effusions, lobar collapse, or nodules\n   4. Respiratory failure not fully explained by heart failure or fluid overload\n   5. Onset within 1 week of clinical insult or new\u002Fworsening symptoms\n3. Early in ARDS course\n\n   * Full criteria for ARDS (#2 above) first met within previous 3 days\n   * Current invasive ventilation episode not more than 4 days duration\n   * Current severe hypoxemic episode (receipt of invasive ventilation, noninvasive ventilation, or high-flow nasal cannula) not more than 10 days duration\n\nExclusion Criteria:\n\n1. Esophageal manometry already in use clinically\n2. Severe brain injury: including suspected elevated intracranial pressure, cerebral edema, or Glasgow coma score (GCS) ≤ 8 directly caused by severe brain injury (e.g., ischemia or hemorrhage)\n3. Gross barotrauma or chest tube inserted to treat barotrauma (note: chest tube inserted strictly for drainage of pleural effusion is not an exclusion)\n4. Esophageal pathology that, in judgement of the site investigator, significantly increases risk of esophageal catheter placement, including high-risk esophageal varices, recent oropharyngeal or gastroesophageal surgery; or past esophagectomy\n5. Ongoing severe coagulopathy (platelet \\\u003C 5000\u002FμL or INR \\> 4)\n6. Extracorporeal membrane oxygenation (ECMO) or CO2 removal (ECCO2R)\n7. Neuromuscular disease that impairs spontaneous breathing (including but not limited to amyotrophic lateral sclerosis, Guillain-Barré syndrome, spinal cord injury at C5 or above)\n8. Any of the following severe chronic lung diseases: cystic fibrosis, acute bronchiectasis exacerbation, acute exacerbation of a chronic interstitial lung disease (ILD), chronic pulmonary hypertension (PH) on PH-targeted vasoactive medication, or lung transplant\n9. End-stage chronic cirrhosis with Child-Pugh Class C (Section 12.3)\n10. ICU admission for burn injury\n11. Current ICU stay \\> 2 weeks or acute care hospital stay \\> 4 weeks\n12. Moribund patient not expected to survive 24 hours as assessed by the study physician; if cardiopulmonary resuscitation (CPR) was provided, assessment for moribund status must occur at least 6 hours after CPR was completed\n13. Current limitation on life-sustaining care (other than do-not-resuscitate), or expectation by clinical team that a limitation on life-sustained care will be adopted within next 24 hours.\n14. Treating clinician refusal or unwilling to use protocol-specified ventilator settings\u002Fmodes\n15. Prisoner\n16. Previous enrollment in this trial","ALL","18 Years",{"count":571,"type":572},1100,"ESTIMATED","INTERVENTIONAL",[575],"PHASE3","The goal of this interventional study is to compare standard mechanical ventilation to a lung-stress oriented ventilation strategy in patients with Acute Respiratory Distress Syndrome (ARDS). Participants will be ventilated according to one of two different strategies. The main question the study hopes to answer is whether the personalized ventilation strategy helps improve survival.",[578,579],"Acute Respiratory Distress Syndrome","Respiratory Failure",[581,582,583,584,585,586],"critical care","critical illness","esophageal manometry","transpulmonary pressure","mechanical ventilation","lung stress","2026-06-25",{"date":589,"type":590},"2026-06-29","ACTUAL",{"date":592,"type":590},"2024-06-24",{"date":594,"type":572},"2030-12-31",{"name":5,"class":6},33]