[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635867":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":55,"locations":65,"responsibleParty":99,"collaborators":102,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":115,"sex":120,"minAge":121,"maxAge":59,"enrollmentInfo":122,"targetDuration":59,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":132,"overallStatus":186,"whyStopped":59,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},{"fullName":5,"class":6},"Ohio State University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-Invasive Positive Pressure Ventilation (NIPPV)","ACTIVE_COMPARATOR","Participants (randomized) who are experiencing acute hypoxemic respiratory failure will be placed on Non-Invasive Positive Pressure Ventilation (NIPPV), by face mask.",[13],"Device: Non-Invasive Positive Pressure Ventilation",{"label":15,"type":10,"description":16,"interventionNames":17},"High Flow Nasal Oxygen (HFNO)","Participants (randomized) who are experiencing acute hypoxemic respiratory failure will be placed on humidified High-Flow Nasal Oxygen (HFNO), delivered to the participant through a specially designed nasal cannula.",[18],"Device: High Flow Nasal Oxygen",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Non-Invasive Positive Pressure Ventilation","Oxygen is delivered with positive pressure through a face mask covering the nose and mouth.",[9],[26],"NIPPV",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"High Flow Nasal Oxygen","Humidified oxygen is delivered to the participant through a specially-designed nasal cannula.",[15],[32],"HFNO",[34,37,40,43,47,50,53],{"name":35,"affiliation":5,"role":36},"Henry E Wang, MD, MS","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":39,"role":36},"Jarrod Mosier, MD","University of Arizona",{"name":41,"affiliation":42,"role":36},"Mark Tidswell, MD","Baystate Health",{"name":44,"affiliation":45,"role":46},"William Meurer, MD","University of Michigan - Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) Clinical Coordinating Center","STUDY_DIRECTOR",{"name":48,"affiliation":49,"role":46},"Robert Silbergleit, MD","University of Michigan - SIREN Clinical Coordinating Center",{"name":51,"affiliation":52,"role":36},"Valerie Durkalski-Mauldin, PhD","Medical University of South Carolina - SIREN Data Coordinating Center",{"name":54,"affiliation":5,"role":36},"Lai Wei, PhD",[56,61],{"name":35,"role":57,"phone":58,"phoneExt":59,"email":60},"CONTACT","614-648-1372",null,"Henry.wang@osumc.edu",{"name":62,"role":57,"phone":63,"phoneExt":59,"email":64},"Valerie L Durkalski-Mauldin, PhD","843-876-1911","durkalsv@musc.edu",[66,89],{"facility":67,"status":59,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Ohio State East Hospital","Columbus","Ohio","43203","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-82.99879,39.96118,{"lat":77,"lon":76},[80,84,88],{"name":81,"role":57,"phone":82,"phoneExt":59,"email":83},"Jason Bischof, MD","614-293-8305","jason.bischof@osumc.edu",{"name":85,"role":57,"phone":86,"phoneExt":59,"email":87},"Michael Hill","614-293-6185","michael.hill@osumc.edu",{"name":81,"role":36,"phone":59,"phoneExt":59,"email":59},{"facility":90,"status":59,"city":68,"state":69,"zip":91,"country":71,"countryCode":72,"cosmosGeoPoint":92,"geoPoint":94,"contacts":95},"OSU Wexner Medical Center","43210",{"type":74,"coordinates":93},[76,77],{"lat":77,"lon":76},[96,97,98],{"name":81,"role":57,"phone":82,"phoneExt":59,"email":83},{"name":85,"role":57,"phone":86,"phoneExt":59,"email":87},{"name":81,"role":36,"phone":59,"phoneExt":59,"email":59},{"type":36,"investigatorFullName":100,"investigatorTitle":101,"investigatorAffiliation":5,"oldNameTitle":59,"oldOrganization":59},"Henry Wang, MD","Principal Investigator",[103,106,108,110,111],{"name":104,"class":105},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",{"name":107,"class":6},"University of Michigan",{"name":109,"class":6},"Medical University of South Carolina",{"name":39,"class":6},{"name":112,"class":6},"Baystate Medical Center","100635867","win-ratio-analysis-to-determine-a-strategy-of-non--invasive-support-for-respiratory-failure-in-the-emergency-department-100635867",false,"NCT07558265","WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department","WINDSURFER","Inclusion Criteria:\n\n* Age ≥18 years\n* Presenting to the Emergency Department (ED) with Acute Hypoxemic Respiratory failure (AHRF), defined as:\n\n  * \\[(respiratory rate ≥25 breaths\u002Fmin) AND (requiring ≥6 L\u002Fmin of oxygen required to maintain SpO2 ≥90%), OR SpO2:FiO2 ratio\\\u003C250\\] OR\n  * Arrival at ED on prehospital Non-Invasive Respiratory Support (NIRS).\n* Clinical need for NIRS\n* Randomization ≤2 hours after identification of need for NIRS\n* Randomization ≤6 hours of ED arrival\n\nExclusion Criteria:\n\n* Urgent need for intubation\n* Cardiac arrest\n* Respiratory arrest\n* Patient not located in the ED\n* Craniofacial anatomic features that prohibit either Non-Invasive Positive Pressure Ventilation (NIPPV) or High Flow Nasal Oxygen (HFNO) interface\n* Tracheostomy or laryngectomy stoma\n* Hemodynamic instability requiring \\>0.2mcg\u002Fkg\u002Fmin of norepinepherine (or equivalent) to maintain mean arterial pressure \\>65mmHg\n* Pre-existing \"do not resuscitate\" or \"do not intubate\" order\n* Home use of non-invasive positive-pressure ventilation for respiratory support of a medical condition other than sleep apnea\n* Transferred from another Emergency Department\n* History of advanced chronic obstructive pulmonary disease\n* History of advanced heart failure\n* Presence of opt-out identification\n* Prisoner\n* Known or apparent pregnant\n* Previous enrollment in WINDSURFER\n* A patient-specific contraindication makes one assigned study intervention unsafe","ALL","18 Years",{"count":123,"type":124},500,"ESTIMATED","INTERVENTIONAL",[127],"NA","The purpose of this clinical trial is to determine the best initial non-invasive respiratory support (NIRS) strategy for adults who present to the emergency department with acute hypoxemic respiratory failure, a condition in which blood oxygen levels are dangerously low and require urgent treatment. This study compares two commonly used non-invasive respiratory support strategies to evaluate their effectiveness and safety, based on important patient outcomes during hospitalization, including survival, the need for invasive mechanical ventilation, and the duration of respiratory support. Participants will be randomly assigned (with an equal chance) to receive one of the following treatments:\n\n* Non-Invasive Positive Pressure Ventilation (NIPPV): Oxygen delivered under pressure through a face mask.\n* High-Flow Nasal Oxygen (HFNO): Oxygen delivered at high-flow through a specially designed nasal cannula placed in the nostrils.\n\nResearchers will compare the two treatment strategies using a hierarchical assessment of major pulmonary outcomes, including:\n\n* Hospital survival\n* Days on mechanical ventilation\n* Duration of non-invasive respiratory support\n\nAs part of the study, researchers will collect:\n\n* Blood and urine samples\n* Physiologic measurements (such as chest movement measured through sensors placed on the skin)\n* Information from participants' medical records",[130,131],"Acute Hypoxic Respiratory Failure","Acute Respiratory Distress Syndrome (ARDS)",[133,134,135,136,137,138,139,140,32,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,26,22,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,118,182,183,184,185],"Acute Hypoxemic Respiratory Failure","Acute Decompensated Heart Failure","Acute Respiratory Distress Syndrome","BiPAP","BPAP","COPD","Chronic Obstructive Pulmonary Disease","Continuous Positive Airway Pressure","High-Flow Nasal Oxygen","EPAP","Expiratory Positive Airway Pressure","FiO2","Inspired Oxygen Fraction","IMV","Invasive Mechanical Ventilation","IPAP","Inspiratory Positive Airway Pressure","MAPE","Major Adverse Pulmonary Events","MV","Mechanical Ventilation","NIRS","Non-Invasive Respiratory Support","PaCO2","Partial pressure of carbon dioxide in arterial blood","PaO2","Partial pressure of oxygen in arterial blood","P:F","Ratio of PaO2 to FiO2","RR","Respiratory Rate","P-SILI","Patient Self-Inflicted Lung Injury","RRT","Renal Replacement Therapy","RSFD","Respiratory Support Free Days","S:F","Ratio of SpO2 to FiO2","SpO2","Transcutaneous measurement of peripheral arterial saturation","UADE","Unanticipated Adverse Device Effects","VAS","Visual Analog Scale","VDays","Ventilator Days","VFD","Ventilator-Free Days","WIN ratio analysis to determine a strategy of non-invasive support for respiratory failure in the emergency department trial","WR","WIN Ratio","Bilevel Positive Airway Pressure","NOT_YET_RECRUITING","2026-05-05",{"date":189,"type":190},"2026-05-07","ACTUAL",{"date":192,"type":124},"2026-07",{"date":194,"type":124},"2031-08",{"name":5,"class":6},2]