[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100398668":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":28,"locations":38,"responsibleParty":61,"collaborators":23,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":23,"enrollmentInfo":72,"targetDuration":23,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":41,"whyStopped":23,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University Hospital, Rouen","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"High-Flow Oxygen Therapy, followed by Non-Invasive Ventilation","oxygenation first by High-Flow Oxygen Therapy, then by O2C, then by Non-Invasive Ventilation",[12],"Other: HFO\u002FO2C\u002FNIV",{"label":14,"type":6,"description":15,"interventionNames":16},"Non-Invasive Ventilation, followed by High-Flow Oxygen Therapy","oxygenation first by Non-Invasive Ventilation, then by O2C, then by High-Flow Oxygen Therapy",[17],"Other: NIV\u002FO2C\u002FHFO",[19,24],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"HFO\u002FO2C\u002FNIV","High-flow oxygen therapy + O2C + Non invasive ventilation",[9],null,{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"NIV\u002FO2C\u002FHFO","Non invasive ventilation + O2C + High-flow oxygen therapy",[14],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":23,"email":33},"Elisabeth Surlemont, Dr","CONTACT","+33232881705","Elisabeth.Surlemont@chu-rouen.fr",{"name":35,"role":31,"phone":36,"phoneExt":23,"email":37},"Emmanuel Besnier, Dr","+332888283","Emmanuel.Besnier@chu-rouen.fr",[39],{"facility":40,"status":41,"city":42,"state":23,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Chu Rouen","RECRUITING","Rouen","76031","France","FR",{"type":47,"coordinates":48},"Point",[49,50],1.09932,49.44313,{"lat":50,"lon":49},[53,55,57,59],{"name":35,"role":31,"phone":54,"phoneExt":23,"email":37},"02 32 88 17 05",{"name":35,"role":56,"phone":23,"phoneExt":23,"email":23},"PRINCIPAL_INVESTIGATOR",{"name":30,"role":58,"phone":23,"phoneExt":23,"email":23},"SUB_INVESTIGATOR",{"name":60,"role":58,"phone":23,"phoneExt":23,"email":23},"Christophe Girault, Dr",{"type":62,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100398668","non-invasive-ventilation-and-high-speed-oxygen-therapy-effects-on-heart-function---hiflow-heart-study-100398668",false,"NCT04471129","Non-invasive Ventilation and High-speed Oxygen Therapy Effects on Heart Function - HiFlow-Heart Study","HiFlow-Heart","Inclusion Criteria:\n\n1. Major patient\n2. Patient who has undergone cardiac surgery with extracorporeal circulation for more than 24 hours and has been extubated for at least 6 hours.\n3. Pre-operative heart failure with left ventricular ejection fraction \\\u003C 40%.\n4. Invasive monitoring by pulmonary arterial catheter (Swan-Ganz) with transpulmonary thermodilution and by radial arterial catheter intended for use in the intra- and post-operative monitoring of the patient.\n5. Treatment with conventional oxygen therapy (O2C) without an increase in O2 flow for more than 30 minuts, without signs of hypoxemia (SpO292%)\n6. Stable hemodynamic parameters: no changes in hemodynamic parameters (arterial pressures and pulmonary and cardiac index) by more than 10% over the 30 minutes prior to inclusion and no increase in cardiotropic medication for at least 30 minutes.\n7. Patient with an oxygenation rate ≤ 6L\n8. For women of child-bearing age: negative pregnancy test at inclusion\n9. Person who has read and understood the information letter and signed the consent form\n10. Affiliation to a social security scheme\n\nExclusion Criteria:\n\n1. Contraindication to the use of NIV or HFO\n2. Patient with orotracheal intubation or tracheotomy\n3. Renal failure with hemodialysis or hemofiltration\n4. Uncontrolled state of shock (PAS\\\u003C90 mmHg and\u002For cardiac index\\\u003C1.8 L\u002Fmin\u002Fm² and\u002For norepinephrine\\>0.2 μg\u002Fkg\u002Fmin and\u002For dobutamine\\>10 μg\u002Fkg\u002Fmin)\n5. Acute respiratory failure as defined by :\n\n   * clinical signs: respiratory rate \\>35\u002Fmin, signs of struggle, SpO2\\\u003C92% on O2C\n   * indication for treatment with NIV or HFO at the discretion of the clinician\n   * oxygen dependency requiring O2C\\>6L\u002Fmin O2C flow at the oxygen mask\n6. Chronic advanced respiratory disease\n7. Chronic treatment with NIV or CPAP at home\n8. Non-operated aortic or mitral insufficiency ≥ II\u002FIV\n9. Administration of loop diuretics within 3 hours prior to inclusion for intravenous forms and within 6 hours for oral forms.\n10. Presence of altered consciousness defined by a Glasgow score \\\u003C 15\u002F15 or cognitive dysfunction defined by a CAM-ICU score \\> 0\u002F4\n11. Pregnant or parturient or nursing woman or proven lack of effective contraception\n12. Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection \u002F subtutorship or guardianship\n13. Person participating in another trial \u002F having participated in another trial that may interfere with the procedures that are the subject of the research within a 4-week time frame","ALL","18 Years",{"count":73,"type":74},30,"ESTIMATED","INTERVENTIONAL",[77],"NA","The investigators hypothesize that the airway pressures generated by High Flow Oxygen Therapy could have a beneficial impact in patients with heart failure, particularly by lowering capillary pulmonary arterial pressures. However, results compared to Non-Invasive Ventilation are difficult to predict due to the lack of data in the literature.",[80],"Chronic Heart Failure",[82,83,84,85],"chronic heart failure","heart surgery","invasive mechanical ventilation","high flow oxygen therapy","2026-03-13",{"date":88,"type":89},"2026-03-16","ACTUAL",{"date":91,"type":89},"2020-09-16",{"date":93,"type":74},"2026-09-16",{"name":5,"class":6},1]