[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100456717":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":23,"locations":29,"responsibleParty":45,"collaborators":18,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":18,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":18,"enrollmentInfo":58,"targetDuration":18,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":32,"whyStopped":18,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Dalarna County Council, Sweden","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PEP-device","EXPERIMENTAL","Positive expiratory pressure device: continuous treatment with PEP-device breathing air for 20 minutes followed by 10 minutes rest and assessment. Inspiration through nose\u002Fmouth, expiration through device.",[13],"Device: PEP-device",{"label":15,"type":16,"description":17,"interventionNames":18},"spontaneous recovery","NO_INTERVENTION","Control group: Resting and breathing air for 20 + 10 minutes.",null,[20],{"type":21,"name":9,"description":9,"armGroupLabels":22,"otherNames":18},"DEVICE",[9],[24],{"name":25,"role":26,"phone":27,"phoneExt":18,"email":28},"Maria Hårdstedt, MD\u002FPhD","CONTACT","46-738089464","maria.hardstedt@regiondalarna.se",[30],{"facility":31,"status":32,"city":33,"state":18,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Center of Clinical Research Dalarna","RECRUITING","Falun","79182","Sweden","SE",{"type":38,"coordinates":39},"Point",[40,41],15.62597,60.60357,{"lat":41,"lon":40},[44],{"name":25,"role":26,"phone":18,"phoneExt":18,"email":18},{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Maria Hårdstedt","Dr. Maria Hårdstedt, PhD, Specialist Internal Medicine","100456717","pep-device-for-treatment-of-swimming-induced-pulmonary-edema-sipe-100456717",false,"NCT05227222","PEP-device for Treatment of Swimming-induced Pulmonary Edema (SIPE)","Evaluation of Positive Expiratory Pressure Device (PEP-device) for Treatment of Swimming Induced Pulmonary Edema (SIPE) - a Randomized Single-blinded Controlled Study","Inclusion Criteria:\n\n* clinical diagnosis of swimming induced pulmonary edema (SIPE) with need of acute treatment\n* peripheral oxygen saturation ≥92%\n* 18 years or older\n* informed consent\n\nExclusion Criteria:\n\n* declined consent\n* suspected acute coronary syndrome\n* severe asthma diagnosed together with pulmonary edema with requirement of beta-agonist-inhalation prior to treatment of pulmonary edema\n* hemodynamic instability or decreased consciousness","ALL","18 Years",{"count":59,"type":60},40,"ESTIMATED","INTERVENTIONAL",[63],"NA","In swimming induced pulmonary edema (SIPE), there is a lack of knowledge regarding optimal treatment. The present study was designed to assess the benefit of treatment with positive expiratory pressure device (PEP-device) compared to spontaneous recovery in patients with SIPE without hypoxia in the out-of-hospital environment.",[66,67,68],"Swimming Induced Pulmonary Edema (SIPE)","Pulmonary Edema","Lung Diseases",[70,71,72,73],"positive expiratory pressure","therapeutics","ultrasonography","oximetry","2025-02-25",{"date":76,"type":77},"2025-02-27","ACTUAL",{"date":79,"type":77},"2022-07-02",{"date":81,"type":60},"2027-07-15",{"name":5,"class":6},1]