[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491147":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":41,"centralContacts":45,"locations":50,"responsibleParty":66,"collaborators":11,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":11,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":11,"enrollmentInfo":78,"targetDuration":11,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":53,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Columbia University","OTHER",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"HFNC only","ACTIVE_COMPARATOR",null,[13],"Device: HFNC only",{"label":15,"type":16,"description":11,"interventionNames":17},"HFNC + CNEP10","EXPERIMENTAL",[18],"Device: HFNC + CNEP10",{"label":20,"type":16,"description":11,"interventionNames":21},"HFNC + CNEP20",[22],"Device: HFNC + CNEP20",{"label":24,"type":16,"description":11,"interventionNames":25},"HFNC + CNEP30",[26],"Device: HFNC + CNEP30",[28,32,35,38],{"type":29,"name":9,"description":30,"armGroupLabels":31,"otherNames":11},"DEVICE","HFNC for 45 minutes, with FiO2 titrated to SpO2 of 90-97%",[9],{"type":29,"name":15,"description":33,"armGroupLabels":34,"otherNames":11},"HFNC with CNEP of 10 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%",[15],{"type":29,"name":20,"description":36,"armGroupLabels":37,"otherNames":11},"HFNC with CNEP of 20 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%",[20],{"type":29,"name":24,"description":39,"armGroupLabels":40,"otherNames":11},"HFNC with CNEP of 30 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%",[24],[42],{"name":43,"affiliation":5,"role":44},"Jeremy Beitler, MD, MPH","PRINCIPAL_INVESTIGATOR",[46],{"name":43,"role":47,"phone":48,"phoneExt":11,"email":49},"CONTACT","212-305-0334","jrb2266@cumc.columbia.edu",[51],{"facility":52,"status":53,"city":54,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Columbia University Irving Medical Center","RECRUITING","New York","10032","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-74.00597,40.71427,{"lat":62,"lon":61},[65],{"name":43,"role":47,"phone":48,"phoneExt":11,"email":49},{"type":44,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Jeremy Beitler","Assistant Professor of Medicine","100491147","physiological-effects-of-continuous-negative-external-pressure-for-acute-hypoxemic-respiratory-failure-100491147",false,"NCT05675345","Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure","Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure: A Pilot Crossover Trial","Inclusion Criteria:\n\n* Age 18 years or older\n* Acute hypoxemic respiratory failure\n* Non-cardiogenic airspace opacities on chest radiograph or computed tomography (CT) scan\n* High-flow nasal cannula (flow ≥ 30 LPM) initiated within last 96 hours (4 days)\n* FiO2 ≥ 40%\n* SpO2 ≥ 92%\n\nExclusion Criteria:\n\n* Do-not-intubate order\n* Anatomical factor predisposing to poor fit of cuirass (e.g. severe kyphosis or scoliosis)\n* Use of cuirass precluded, e.g. due to:\n\n  * Clinically prescribed prone positioning\n  * Tense ascites\n  * Severe abdominal pain\n  * Abdominal wound or surgery\n  * Pregnancy\n  * Agitated delirium\n* Prior intubation during hospital stay\n* Cardiogenic pulmonary edema\n* Exacerbation of asthma or COPD\n* Chronic lung disease, including:\n\n  * Interstitial lung disease\n  * Cystic fibrosis\n  * Lung mass, lung cancer, or metastasis to the lung\n  * Lung transplant recipient\n  * Any disease that requires home oxygen\n* Glasgow coma score \\\u003C 15\n* Chest tube, pneumothorax, or pneumomediastinum\n* Hemodynamic instability (mean arterial pressure \\\u003C 55 mmHg or norepinephrine-equivalent vasopressor requirement \\> 0.1mcg\u002Fkg\u002Fmin)\n* Implantable electrical device (e.g. pacemaker, defibrillator, neurostimulator)\n* Unreliable pulse-oximetry tracing\n* Imminent intubation\n* Anticipated lack of patient availability to complete study procedures (e.g. due to planned clinical procedure such as CT scan or dialysis during potential time of study)\n* Attending physician refusal","ALL","18 Years",{"count":79,"type":80},20,"ESTIMATED","INTERVENTIONAL",[83],"NA","This study is being conducted to evaluate if wearing a non-invasive breathing support device over the chest\u002Fabdomen improves markers of breathing in patients with lung injury requiring high-flow oxygen. The breathing support device consists of a plastic shell that sits over the chest and abdomen and connects to a vacuum that helps the chest expand with breathing. This breathing support is known as continuous negative external pressure (CNEP). Study findings will help determine if this breathing support device might be useful for patients with acute hypoxemic respiratory failure (AHRF).",[86],"Acute Hypoxemic Respiratory Failure",[88,89,90,91,92,93],"acute respiratory distress syndrome","noninvasive ventilation","mechanical ventilation","oxygen inhalation therapy","atelectasis","high-flow nasal cannula","2024-02-29",{"date":96,"type":97},"2024-03-04","ACTUAL",{"date":99,"type":97},"2024-02-28",{"date":101,"type":80},"2026-12-31",{"name":5,"class":6},1]