[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100325285":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":40,"studyPopulation":29,"armGroups":41,"interventions":54,"overallOfficials":62,"centralContacts":67,"locations":76,"responsibleParty":94,"collaborators":29,"id":98,"slug":29,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":29,"enrollmentInfo":107,"targetDuration":29,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":79,"whyStopped":29,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Papa Giovanni XXIII Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Clinical Failure","The primary endpoint is the achievement of clinical failure defined as:\n\nAt least one of major criteria Or\n\nAt least 2 or more of the minor criteria maintained for at least 1 consecutive hour:\n\nMAJOR CRITERIA:\n\nCardiac or respiratory arrest Breathing pauses with loss of consciousness Severe hemodynamic instability (Heart Rate ≤ 50 bpm with loss of alertness or Systolic Blood Pressure ≤ 70 mmHg) Need for sedation\n\nMINOR CRITERIA (observed for ≥ 1 hour):\n\nReduction ≥30% of the value of the PaO 2 \u002F FiO 2 compared to baseline Increased 20% if PaCO2 PaCO2 previous ≥40mmHg Worsening alertness as increased by one degree on the Kelly scale (see Appendix II) Persistence or onset of respiratory distress ( severe dyspnea or use of accessories respiratory muscles or paradoxical abdominal motion)","Participants will be followed for the duration of hospital stay, for a maximum of 30 days",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"30-day mortality after admission","mortality rate at 30 days after admission","day 30",{"measure":19,"description":20,"timeFrame":21},"improvement of respiratory exchanges compared to baseline","arterial blood gas evaluation of gas exchange and ventilation","hospital admission (=day 1), day 2, until the achievement of clinical stability",{"measure":23,"description":24,"timeFrame":25},"adverse events","observation adverse events rate","Hospital discharge; participants will be followed for the duration of hospital stay, an expected average of 1 week",{"measure":27,"description":28,"timeFrame":25},"hospital stay","length of hospital stay",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":29,"timePerspective":29,"maskingInfo":35},"RANDOMIZED","PARALLEL","open randomized controlled trial","TREATMENT",{"masking":36,"maskingDescription":37,"whoMasked":38},"SINGLE","Assessor will be blind to the treatment allocation",[39],"OUTCOMES_ASSESSOR","1.1 Basic information Pneumonia is still the most important infectious disease in terms of morbidity and mortality and is one of the most common causes of hospitalization for acute respiratory failure. The aim of this trial is to compare the use of High Flow Nasal Cannula (HFNC) oxygenation versus standard oxygen therapy in patients with hypoxemia due to pneumonia.\n\n1.2 Rationale The oxygenation through HFNC allows the use of high concentrations of oxygen administered by a high gas flow, heated and humidified. This device allows both higher FiO2 and the presence of a positive end-expiratory pressure (PEEP) with a greater gas exchange.\n\n2\\. Aims OF THE STUDY 2.1 Primary aim The primary aim 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 clinical failure during acute respiratory failure due to severe pneumonia 2.2 Secondary aims\n\nThe secondary aims are:\n\n30-day mortality gas exchange improvement in-hospital length of stay adverse events as per prior\n\n3\\. STUDY DESIGN 3.1 Design This is randomized, open, controlled, multicenter study 3.2 Number of patients The sample size is 150 patients. The enrolled subjects will be randomized in two Arms: Arm 1, intervention, 75 patients treated with HFNC, minimum flow ≥ 60L \u002F min, FiO2 such as to maintain a SpO2 ≥ 92%, and Arm 2, reference technique, 75 patients treated with oxygen with Venturi mask, with FiO2 as to maintain a SpO 2 ≥ 92%.\n\n3.3 Duration of the study The estimated time to complete the recruitment of cases is 24 months. Each subject will be followed from enrolment until discharge.\n\n3.4 Evaluation 3.5.1 Primary endpoint The primary endpoint is the achievement of clinical failure defined as at least one major criteria Or\n\nAt least ≥2 of the minor criteria maintained for at least 1 consecutive hour:\n\nMAJOR CRITERIA:\n\nCardiac or respiratory arrest Breathing pauses with loss of consciousness Severe hemodynamic instability Need for sedation\n\nMINOR CRITERIA:\n\nReduction ≥30% of the value of the PaO 2 \u002F FiO 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\n\n3.5.2 Secondary endpoint\n\nThe secondary endpoint includes:\n\n30 days mortality after admission. improvement of respiratory exchanges compared to baseline, rated at 1, 24 and 48 hours and at the achievement of clinical stability with arterial blood gas.\n\nrate of adverse events length of hospital stay. 3.5.3 Follow-up At 30 days from admission, each subject will be assessed, possibly through telephone contact, to determine the status of life (secondary endpoint).\n\n4\\. STUDIED POPULATION AND SELECTION CRITERIA 4.1 Examined population The studied population consists of individuals with pneumonia presenting to the Emergency Departments 4.2 Inclusion\u002Fexclusion criteria (see appropriate section)\n\n5\\. SCREENING PROCEDURES, RANDOMISATION, MASKING 5.1 Randomization The statistician of the study will make randomization, preparing a list generated by the computer using a special program. The experimenter center will receive a group of envelopes progressively numbered, opaque, sealed in order to avoid any opening.\n\n5.2 Masking This study is open, not being justified a possible double masking technique or sham procedures.\n\n6\\. SCHEDULE AND STUDY PROCEDURES The study is divided into a baseline visit, followed by 1 visit at 1 hour, in the next 24 hours, followed by another visit during the 48-hour and the last when clinical stability is achieved The patient then will be followed until discharge and with a visit or a follow-up interview after 30 days of admission to determine the status of life.\n\n6.1 Clinical evaluation\n\nClinical evaluations include:\n\ncollection of history (prior and concomitant diseases), and any concomitant therapies complete physical exam only at baseline respiratory symptoms at each evaluation vital signs during each evaluation dyspnea assessment at every clinical evaluation, using the Borg scale axillary body temperature (BT) every 8 hours Kelly scale assessment at each evaluation.\n\n6.2 Laboratory evaluations Unless otherwise specified, the following tests will be performed on admission, 24 hours and then every 48 hours until discharge criteria are reached.\n\nCBC: (5 mL in EDTA); Biochemistry: blood urea nitrogen, creatinine, serum sodium, potassium, glucose, ALT, AST, creatine phosphokinase (CPK), bilirubin, C-reactive protein, albumin (5 mL whole blood); lactates: performed at baseline and subsequent blood gas controls (3 mL of whole blood) pregnancy test on the urine sample (only at baseline) The arterial blood gas analysis (BGA) with the calculation of PaO2\u002FFiO2 will be performed on admission, at 1, 24, at 48 hours, and at the achievement of clinical stability, and whenever there is a clinical worsening.\n\n6.3 Instrumental exams Routine chest x-ray on admission, as well as whenever a clinical deterioration occurs.\n\n6.4 Examinations plan 6.4.1 Baseline medical exam For each patient it will be made physical examination and lab evaluation as described previously Then it will proceed to randomization as indicated in § 5.2. 6.4.2 Treatment period The doctor in charge is free to perform all measurements, including BGA, as needed to assess the patient's condition. These will be in the clinic folder but they are not part of the data analyzed for the study, with the exception of blood gas analysis necessary to determine the minor intubation criteria (§ 3.5.1). Such measures will be noted for determination of primary endpoint, but they will not be used for the measurement of gas exchange trend (secondary endpoint).\n\nFor the analysis of secondary endpoint, after 24 hours, 48 hours and the achievement of clinical stability should be measured and recorded:\n\nvital parameters (BP, HR, RR). The BT is measured every 8 hours with other vital parameters evaluation of dyspnea using both the Borg scale and the Kelly scale adverse events BGA during the treatment with lactate measurement (maintaining the HFNC and oxygen therapy with a mask as defined for randomization) and evaluation of P\u002FF ratio, A-a difference of O2 and arterial O2 consumption.\n\n24 hours after randomization there will be rated the severity score the SAPS-II scale and the SOFA score in case of sepsis.\n\nEvery 48 hours there will be performed blood samples (CBC, biochemistry, CRP) until the clinical stability is reached.\n\nIf intubation criteria are reached, the study must be regarded as concluded. For patients enrolled in HFNC arm, the ventilatory support therapy using HFNC must be continued until the clinical stability, considered as the fulfillment of the following clinical stability.\n\nAfter attainment of all clinical stability, there will be an attempt to remove HFNC and to put the patient in Venturi mask, with the same FiO2 as the HFNC used before.\n\nThis step will be considered definitive when one hour after the attempt the SpO2 remains 94-98% and the absence of respiratory distress or FR \\\u003C25 acts per minutes.\n\nFor patients in Venturi group, as soon as clinical stability is reached through the fulfillment of clinical stability criteria, the successive evaluation takes place at the time of discharge.\n\n6.4.3 End-study medical examination The visit will take place at the end of the study at the time of discharge or when intubation criteria will be achieved.\n\nEvaluation will include:\n\nvital parameters (BP, HR, RR) respiratory symptoms using both the Borg and the Kelly scale SpO2 6.4.4 Observations to 30 days or in case of unplanned evaluation\n\nAfter 30 days of enrolment the patient will be requested via telephone interview of the subject or of the reference family:\n\nIf the participant is alive any hospitalization\n\n7\\. STUDIED TECHNIQUES The two techniques in this trial are widely known and used for oxygen therapy, although still lacks a comparative assessment of efficiency in the case examined in this study\n\n8\\. ASSESSMENT OF SCIENTIFIC AIMS 8.1 See appropriate section on Outcome measures 9. STATISTICAL CONSIDERATIONS 9.1 Studied population The study population consists of adult and consenting subjects, from to the ER population diagnosed with pneumonia as the unique cause of acute respiratory and PaO2\u002FFiO2 ≤ 250 during oxygen with Venturi mask with FiO2 50% administered for at least 60 minutes.\n\n9.2 Study design The study follows the randomized, controlled design vs. standard open intervention. Randomization is defined by the main statistician. The center receives a set of disposable sealed envelopes, opaque, prepared by the main statistician in blocks in accordance with procedures stored by itself. Each subject enrolled will receive the treatment indicated inside the envelope with the lowest number available.\n\n9.3 Outcome measures of the study See appropriate section on Outcome Measures\n\n9.4 Study hypothesis The study aims to evaluate the null hypothesis according to the proportion of patients reaching the primary endpoint does not differ in its populations.\n\n9.5 Sample size The aim of the study is the null hypothesis examination, which indicates that the groups in the two populations are the same.\n\nWith the proposed sample of 75 subjects in both the two groups (a total of 150 subjects), the study has a power of 80% to give statistically significant results. This calculation assumes that the proportion of subjects that reach the primary endpoint is approximately the 60% of the control group and that the treatment in question is able to reduce this proportion of 35%.\n\n9.6 Patients enrolling and follow-up Overall, it is expected to enrol approximately 150 patients. The estimated duration of enrolment is about 12 months. Considering the period of follow up of the patients, the expected study duration is approximately 36 months.\n\n9.7 Analysis plan 9.7.1 Primary variable analysis The primary variable is the proportion of patients who meet the criteria for endotracheal intubation - regardless of the actual intubation - during the treatment until the achievement of the clinical stability criteria. The primary analysis will be performed on the ITT population. The proportion of subjects qualified as a \"failure\" related to the achievement of the criteria for intubation will be analyzed by contingency tables (chi-square) accompanied by the confidence interval of the difference, by the relative risk estimates and by the NNT, if applicable. It may also be analyzed by multivariate logistic regression.\n\nThe proportion of subjects who achieved the outcome at a set time (secondary analysis), if relevant, will be tabulated by relative confidence intervals for the difference and estimated odds-ratios for daily intervals.\n\n9.7.2 Secondary variables analysis The Secondary endpoints include both continuous and binary distribution variables. The 30-day mortality will be analyzed by contingency tables and using multivariate logistic regression, considering as membership population these three categories: HFNC, Venturi (if randomized to standard after treatment maintained until the end of observation) and Mixed (if randomized to standard treatment and subsequently transferred to HFNC before the observation term)",[42,48],{"label":43,"type":44,"description":45,"interventionNames":46},"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",[47],"Device: High Flow Nasal Cannula Oxygenation",{"label":49,"type":50,"description":51,"interventionNames":52},"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",[53],"Device: Venturi Mask Oxygenation",[55,59],{"type":56,"name":43,"description":57,"armGroupLabels":58,"otherNames":29},"DEVICE","Delivery of humidified and heated (37ºC) high flow oxygen",[43],{"type":56,"name":49,"description":60,"armGroupLabels":61,"otherNames":29},"delivery of high flow oxygen",[49],[63],{"name":64,"affiliation":65,"role":66},"roberto cosentini, MD","A.O. Ospedale Papa Giovanni XXIII","STUDY_DIRECTOR",[68,72],{"name":64,"role":69,"phone":70,"phoneExt":29,"email":71},"CONTACT","+39 338 600 2601","r.cosentini@gmail.com",{"name":73,"role":69,"phone":74,"phoneExt":29,"email":75},"andrea duca, MD","+39 339 698 0728","andreaducamd@gmail.com",[77],{"facility":78,"status":79,"city":80,"state":29,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Vicky Rubini","RECRUITING","Bergamo","24127","Italy","IT",{"type":85,"coordinates":86},"Point",[87,88],9.66721,45.69601,{"lat":88,"lon":87},[91],{"name":78,"role":69,"phone":92,"phoneExt":29,"email":93},"3923633715","v.rubini.95@gmail.com",{"type":95,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Roberto Cosentini","MD, Head of Emergency Room","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":108,"type":109},150,"ESTIMATED","INTERVENTIONAL",[112],"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",[115,116],"Respiratory Insufficiency","Pneumonia",[118,119],"High Flow Nasal Cannula","Venturi mask","2024-03-05",{"date":122,"type":123},"2024-03-07","ACTUAL",{"date":125,"type":123},"2023-06-01",{"date":127,"type":109},"2026-06-30",{"name":5,"class":6},1]