[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100443092":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":26,"centralContacts":45,"locations":52,"responsibleParty":79,"collaborators":26,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":26,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":26,"overallStatus":55,"whyStopped":26,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Direction Centrale du Service de Santé des Armées","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"History of Immersion Pulmonary Edema","ACTIVE_COMPARATOR","The participants will have 2 visits:\n\nAt visit 1 (Day 0), the participants will perform a terrestrial exercise, have a transthoracic cardiac ultrasound, a transthoracic pulmonary ultrasound and several blood samples will be collected.\n\nAt visit 2 (Day 7), the participants will perform a swimming exercise, have a transthoracic cardiac ultrasound, a transthoracic pulmonary ultrasound and several blood samples will be collected.",[13,14,15,16,17],"Other: Terrestrial exercise","Other: Swimming exercise","Device: Transthoracic cardiac ultrasound","Device: Transthoracic pulmonary ultrasound","Biological: Blood collection",{"label":19,"type":10,"description":11,"interventionNames":20},"No history of Immersion Pulmonary Edema",[13,14,15,16,17],[22,27,31,36,40],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"Terrestrial exercise","At visit 1 (Day 0), an exercise test will be performed (maximal incremental test), followed by a 30-minute submaximal exercise at constant load.\n\nDuring this exercise, continuous data collection will be performed:\n\n* Continuous 12-lead electrocardiogram\n* Continuous monitoring of blood pressure and ventilation.",[9,19],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Swimming exercise","At visit 2 (Day 7), the subjects will perform a swimming exercise in the experimental pool equipped with a turbine to create a counter-current. The water speed will be constant (4 min per 100 m, i.e. 1.5 km\u002Fh). The duration of the exercise will be 30 minutes. Each diver will breathe with the help of a snorkel.\n\nDuring this exercise, continuous data collection will be performed:\n\n* Continuous 12-lead electrocardiogram\n* Continuous monitoring of blood pressure and ventilation.",[9,19],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"DEVICE","Transthoracic cardiac ultrasound","The participants will have a transthoracic cardiac ultrasound to measure the dilatations of the cardiac cavities at visit 1 and 2.",[9,19],{"type":32,"name":37,"description":38,"armGroupLabels":39,"otherNames":26},"Transthoracic pulmonary ultrasound","The participants will have a transthoracic pulmonary ultrasound to quantify the presence of signs of pulmonary vascular overload (comet tails) at visit 1 and 2.",[9,19],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":26},"BIOLOGICAL","Blood collection","Several blood samples will be collected at visit 1 and 2.",[9,19],[46],{"name":47,"role":48,"phone":49,"phoneExt":50,"email":51},"CASTAGNA Olivier, MD, PhD","CONTACT","483162830","+33","olivier.castagna@intradef.gouv.fr",[53,69],{"facility":54,"status":55,"city":56,"state":26,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Equipe Résidente de Recherche Subaquatique Opérationnelle","RECRUITING","Toulon","83800","France","FR",{"type":61,"coordinates":62},"Point",[63,64],5.92836,43.12442,{"lat":64,"lon":63},[67],{"name":68,"role":48,"phone":49,"phoneExt":50,"email":51},"Olivier CASTAGNA, MD, PhD",{"facility":70,"status":55,"city":56,"state":26,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":71,"geoPoint":73,"contacts":74},"Hôpital d'Instruction des Armées Sainte-Anne",{"type":61,"coordinates":72},[63,64],{"lat":64,"lon":63},[75],{"name":76,"role":48,"phone":77,"phoneExt":50,"email":78},"Jean-Eric BLATTEAU, MD, PhD","483162189","jean-eric.blatteau@intradef.gouv.fr",{"type":80,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100443092","screening-for-individual-susceptibility-factors-to-immersion-pulmonary-edema-100443092",false,"NCT05049889","Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema","RFSI-OPI","Inclusion Criteria:\n\n* Military or civilian diver with at least 100 dives\n* Between the ages of 18 and 60\n* Good physical condition (able to run\u002Fswim for 30 minutes at a constant pace).\n\nExclusion Criteria:\n\n* Divers with a current temporary medical incapacity to dive\n* Persons with contraindications to physical exercise and\u002For scuba diving\n* Pregnant or breastfeeding women",true,"ALL","18 Years","60 Years",{"count":93,"type":94},63,"ESTIMATED","INTERVENTIONAL",[97],"NA","Immersion Pulmonary Edema (IPE) is a relatively new form of hemodynamic pulmonary edema. The number of cases has been increasing over the last ten years and it has become the second most common cause of hospitalization for military divers, after decompression sickness. The pathophysiological mechanisms of IPE are not completely known. Its occurrence is linked to a combination of factors related to the environmental constraints of diving, as well as to the diver's equipment. The main external factors are increased hydrostatic pressure, cold, intense effort and emotional stress. The impact of internal factors is not known. At this time, no severe forms of IPE have been identified in the military. However, it is important to identify this pathology at an early stage, even if the signs appear minor, because the continuation of underwater activity can significantly worsen the clinical picture. The risk of recurrence (greater than 15%) could result in a severe or even lethal accident.",[100],"Pulmonary Edema","2022-09-13",{"date":103,"type":104},"2022-09-14","ACTUAL",{"date":106,"type":104},"2022-08-17",{"date":108,"type":94},"2026-08",{"name":5,"class":6},2]