[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100325285":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":61,"collaborators":25,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":25,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Papa Giovanni XXIII Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"High Flow Nasal Cannula Oxygenation","EXPERIMENTAL","High Flow Nasal Cannula Oxygenation with a minimum flow ≥ 60L \u002F min, and an FiO2 such as to maintain a SpO2 ≥ 92% for at least 48 hours until clinical stability",[13],"Device: High Flow Nasal Cannula Oxygenation",{"label":15,"type":16,"description":17,"interventionNames":18},"Venturi Mask Oxygenation","ACTIVE_COMPARATOR","Venturi Mask Oxygenation, with an FiO2 such as to maintain an SpO2 ≥ 92% for at least 48 hours until clinical stability",[19],"Device: Venturi Mask Oxygenation",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Delivery of humidified and heated (37ºC) high flow oxygen",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"delivery of high flow oxygen",[15],[30],{"name":31,"affiliation":32,"role":33},"roberto cosentini, MD","A.O. Ospedale Papa Giovanni XXIII","STUDY_DIRECTOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+39 338 600 2601","r.cosentini@gmail.com",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"andrea duca, MD","+39 339 698 0728","andreaducamd@gmail.com",[44],{"facility":45,"status":46,"city":47,"state":25,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Vicky Rubini","RECRUITING","Bergamo","24127","Italy","IT",{"type":52,"coordinates":53},"Point",[54,55],9.66721,45.69601,{"lat":55,"lon":54},[58],{"name":45,"role":36,"phone":59,"phoneExt":25,"email":60},"3923633715","v.rubini.95@gmail.com",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Roberto Cosentini","MD, Head of Emergency Room","100325285","high-flow-nasal-cannulae-vs-venturi-mask-in-respiratory-failure-due-to-pneumonia-100325285",false,"NCT03515031","High Flow Nasal Cannulae vs Venturi Mask in Respiratory Failure Due to Pneumonia","Open Randomized Controlled Clinical Trial Comparing Oxygen Therapy by High Flow Nasal Cannulae and by Venturi Mask in the Treatment of Acute Respiratory Failure Due to Severe Pneumonia (Hi Flow Oxygen vs Venturi Mask In Pneumonia)","HiFlOViP","Inclusion Criteria:\n\n* male or female of any ethnic group\n* age greater than or equal to 18 years;\n* respiratory rate (RR) at rest ≥ 20 breaths\u002Fminute or presence of respiratory distress (severe - dyspnea at rest or use of accessory respiratory muscles or paradox abdominal movement) PaO 2\u002F FiO 2 ≤250 during oxygen therapy with Venturi mask with FiO 2 50% administered for at least 60 minutes;\n* diagnosis of pneumonia as the unique cause of acute respiratory failure\n* informed consent obtained from the patient or the closest relative in case of patient's inability to give it.\n\nExclusion Criteria:\n\n* other diagnoses (instead of pneumonia) as a cause of acute respiratory failure\n* unstable angina and acute myocardial infarction in place;\n* Acute respiratory acidosis with pH \\\u003C7.35 and PaCO 2 \\> 45 mmHg;\n* systolic blood pressure \\\u003C90 mmHg unresponsive to fluids or with amines\n* severe arrhythmias;\n* epileptic seizures;\n* the degree of vigilance depending on the Kelly scale \\> 3 (see Appendix II)\n* impaired swallowing, which increases the risk of pneumonia aspiration inability to protect airways\n* craniofacial trauma or burns\n* uncooperative patient\n* presence of open wound (skull, chest, abdomen)\n* respiratory arrest or need for intubation\n* ongoing pregnancy or suspected","ALL","18 Years",{"count":76,"type":77},150,"ESTIMATED","INTERVENTIONAL",[80],"NA","The primary objective of this study is to compare the efficacy of treatment with HFNC (group A) compared to administration of oxygen therapy by Venturi mask (group B, standard therapy) in terms of reaching of endotracheal intubation criteria during acute respiratory failure due to severe pneumonia.\n\nInclusion Criteria: Respiratory rate (RR) at rest ≥20 bpm or presence of respiratory distress (severe dyspnoea at rest or use of accessory respiratory muscles or abdominal paradox); PaO2 \u002F FiO2 ≤250 during oxygenation with Venturi Oxygenation mask at FiO2 = 50% administered for at least 60 minutes; Diagnosis of pneumonia as the sole cause of acute respiratory failure. Randomization: 150 consecutive patients will be randomized either to High Flow Nasal Cannula Oxygenation (75 patients, HFNCO with flow ≥ 60 L\u002Fmin and FiO2 to maintain SpO2 ≥ ) or Venturi Mask Oxygenation (control, 75 patients).\n\nPatients from both groups will be treated with antibiotic therapy according to the IDSA\u002FATS 2007 guidelines for community-acquired pneumonia and the IDSA\u002FATS 2016 guidelines for hospital-acquired pneumonia.\n\nIntubation Criteria:\n\nMAJOR CRITERIA:\n\nCardiac or respiratory arrest Breathing pauses with loss of consciousness Severe hemodynamic instability Need for sedation\n\nMINOR CRITERIA (maintained for ≥1h):\n\nReduction ≥30% of the value of the PaO2\u002FFiO 2 compared to baseline Increased 20% if PaCO2 PaCO2 previous ≥40mmHg Worsening alertness as increased by one degree on the Kelly scale Persistence or onset of respiratory distress Vital parameters, Kelly scale and arterial blood gas analysis (BGA) will be performed on admission, and at 1, 24, at 48 hours, at the achievement of clinical stability, and whenever there is a clinical worsening.\n\nPatients enrolled in HFNC arm will continue HFNC oxygenation until clinical stability, defined as:\n\nBody temperature ≤ 37°C and ≥36°C for 24 consecutive hours Good ability in swallowing CRP and WBC normalization trend than the admission exams Hemodynamic stability Lack of respiratory distress SpO2 94-98% The primary outcome variable is the proportion of patients who reach the endotracheal intubation criteria - regardless of the actual intubation rate - within the first 48 hours of treatment. The primary analysis will be performed on the ITT population",[83,84],"Respiratory Insufficiency","Pneumonia",[86,87],"High Flow Nasal Cannula","Venturi mask","2024-03-05",{"date":90,"type":91},"2024-03-07","ACTUAL",{"date":93,"type":91},"2023-06-01",{"date":95,"type":77},"2026-06-30",{"name":5,"class":6},1]