[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100507784":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":47,"responsibleParty":64,"collaborators":67,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":26,"enrollmentInfo":82,"targetDuration":26,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Supplemental oxygen delivered by facemask","EXPERIMENTAL","Patients with acute PE will be randomized to breathing supplemental oxygen by non-rebreather face mask first.\n\nSubjects will alternate treatments (supplemental oxygen or room air) every 30 minutes for 90 minutes (e.g. T=30, T=60, T=90) and then will maintain their treatment (oxygen or room air) for a total of 180 minutes.",[13,14],"Drug: Oxygen Therapy","Device: Non-rebreather mask",{"label":16,"type":17,"description":18,"interventionNames":19},"Room air delivered by facemask","ACTIVE_COMPARATOR","Patients with acute PE will be randomized to breathing room air by non-rebreather face mask first.\n\nSubjects will alternate treatments (supplemental oxygen or room air) every 30 minutes for 90 minutes (e.g. T=30, T=60, T=90) and then will maintain their treatment (oxygen or room air) for a total of 180 minutes.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Oxygen Therapy","Study subjects will be asked to breathe supplemental, or extra, oxygen during several time periods.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DEVICE","Non-rebreather mask","Non-rebreather mask is a non-invasive oxygen supplementation device that is used to provide continuous oxygen flow, typically in a hospital setting.",[16,9],[33],"NRM (Non-rebreather mask)",[35],{"name":36,"affiliation":5,"role":37},"Christopher Kabrhel, MD, MPH","PRINCIPAL_INVESTIGATOR",[39,43],{"name":36,"role":40,"phone":41,"phoneExt":26,"email":42},"CONTACT","617-726-7622","ckabhrel@mgb.org",{"name":44,"role":40,"phone":45,"phoneExt":26,"email":46},"Blair Alden Parry, CCRC, BA","617-724-4758","bparry@mgh.harvard.edu",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-71.05977,42.35843,{"lat":59,"lon":58},[62,63],{"name":44,"role":40,"phone":45,"phoneExt":26,"email":46},{"name":36,"role":37,"phone":26,"phoneExt":26,"email":26},{"type":37,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Christopher Kabrhel MD MPH","Professor of Emergency Medicine; Attending Physician",[68,71],{"name":69,"class":70},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",{"name":72,"class":6},"Aarhus University Hospital","100507784","early-phase-1-supplemental-oxygen-in-pulmonary-embolism-so-pe-100507784",false,"NCT05891886","Supplemental Oxygen in Pulmonary Embolism (SO-PE)","SO-PE","Inclusion Criteria:\n\n* Adults ≥18 years old\n* Confirmed Pulmonary Embolism (PE) on imaging \\\u003C24 hours prior to enrollment\n* New symptom onset and \u002F or worsening symptoms \\\u003C72 hours\n* Confirmation of right ventricular dysfunction (RVD) by clinician\n* Oxygen saturation ≥90% while breathing room air\n\nExclusion Criteria:\n\n* Hemodynamic instability\n* Use of vasopressors or mechanical circulatory support\n* Planned use of thrombolytics or plan for embolectomy\n* Oxygen saturation \\\u003C90% while breathing room air\n* New onset arrhythmia\n* History of pulmonary hypertension, severe chronic obstructive pulmonary disease (COPD) requiring home oxygen or chronic steroid use, hypoventilation syndrome requiring continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), or congestive heart failure (CHF) with LV ejection fraction \\\u003C 40% or chronic oxygen therapy\n* Known pregnancy\n* Vasodilator medication used in the past 24 hours\n* Symptom onset ≥72 hours\n* Inability to wear a face mask\n* Inability to obtain adequate baseline echocardiogram","ALL","18 Years",{"count":83,"type":84},80,"ESTIMATED","INTERVENTIONAL",[87],"EARLY_PHASE1","A study of how supplemental oxygen helps patients with acute pulmonary embolism (PE).\n\nHypothesis: Oxygen affects right ventricular dysfunction (RVD) in patients with acute pulmonary embolism (PE) primarily by relieving hypoxic pulmonary vasoconstriction and reducing pulmonary pressure (PA) pressure, and that this process is metabolically driven.",[90,91,92,93],"Pulmonary Embolism","Venous Thromboembolism","Metabolomics","Oxygen Inhalation Therapy",[90,95,96],"PE","Right ventricular dysfunction","2025-06-12",{"date":99,"type":100},"2025-06-15","ACTUAL",{"date":102,"type":100},"2023-10-01",{"date":104,"type":84},"2027-06-30",{"name":5,"class":6},1]