[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578775":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":42,"studyPopulation":35,"armGroups":43,"interventions":50,"overallOfficials":56,"centralContacts":60,"locations":68,"responsibleParty":84,"collaborators":87,"id":91,"slug":35,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":35,"studyType":104,"phases":105,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":117,"whyStopped":35,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Università degli Studi di Ferrara","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"To evaluate the changes of inspiratory effort based on the analysis of the oesophageal pressure curve.","Our hypothesis is based on changes of inspiratory effort, based on the analysis of the delta esophageal pressure (ΔPes), after the administration of Salbutamol by via a vibrating mesh nebulizer during HFNC in patients with AHRF. Evaluating the delta esophageal pressure (ΔPes) requires careful measurement of esophageal pressure (Pes) during the respiratory cycle. ΔPes specifically reflects the inspiratory effort or the work of breathing (WOB), as it measures the difference between the maximum inspiratory and expiratory Pes values during each breath.","The measurement of ΔPes will be conducted: After 20 minutes of ventilatory support with HFNC (Time 0) 10 minutes following the completion of Salbutamol administration (Time 1) At 1 hour, 2 hours, and 3 hours post-Salbutamol administration",[14,18,21,24,27,31,33],{"measure":15,"description":16,"timeFrame":17},"Feasibility and safety of administering salbutamol via a vibrating mesh nebulize","To evaluate the feasibility and safety of administering salbutamol via a vibrating mesh nebulizer during HFNC in patients with AHRF. The safety evaluation involves identifying and mitigating potential risks associated with the intervention.\n\nMonitor patients for known side effects of Salbutamol, such as:\n\nTachycardia (\\>100bpm) Arrhythmias (identified by bpm; millisecond)\n\nContinuously monitor:\n\nHeart rate (to detect tachycardia; bpm)","Data Collection Points: Baseline (prior to Salbutamol administration). During nebulization. Post-nebulization at 10 minutes, 1 hour, 2 hours, and 3 hours.",{"measure":19,"description":20,"timeFrame":17},"Feasibility and safety of administering salbutamol via a vibrating mesh nebulize To evaluate the feasibility and safety of administering salbutamol via a vibrating mesh nebulizer during HFNC in patients with AHRF. The safety evaluation involves identif","To evaluate the feasibility and safety of administering salbutamol via a vibrating mesh nebulizer during HFNC in patients with AHRF. The safety evaluation involves identifying and mitigating potential risks associated with the intervention. Hypokalemia (definied \\\u003C3.0 to 3.4 mEq\u002FL)",{"measure":15,"description":22,"timeFrame":23},"To evaluate the feasibility and safety of administering salbutamol via a vibrating mesh nebulizer during HFNC in patients with AHRF. The safety evaluation involves identifying and mitigating potential risks associated with the intervention. Record any exacerbation of respiratory distress or intolerance to the nebulization process. Continuously monitor: Oxygen saturation (SpO₂,%) and respiratory rate (to ensure adequate oxygenation and ventilation)","[Time Frame: Data Collection Points: Baseline (prior to Salbutamol administration). During nebulization. Post-nebulization at 10 minutes, 1 hour, 2 hours, and 3 hours.]",{"measure":15,"description":25,"timeFrame":26},"To evaluate the feasibility and safety of administering salbutamol via a vibrating mesh nebulizer during HFNC in patients with AHRF. Patient Tolerance: Document patient comfort scale (from 1 to 10)",": Baseline (prior to Salbutamol administration). During nebulization. Post-nebulization at 10 minutes, 1 hour, 2 hours, and 3 hours.]",{"measure":28,"description":29,"timeFrame":30},"Evaluation of global and regional ventilation by EIT","To evaluate the improvement of global and regional ventilation based on data obtained with EIT after the administration of salbutamol via a vibrating mesh nebulizer during HFNC in patients with AHRF. EIT provides real-time, non-invasive monitoring of ventilation by measuring regional changes in electrical impedance within the thorax. Parameters to Monitor with EIT: Global Ventilation: Overall changes in lung ventilation during tidal breathing.\n\nRegional Ventilation Distribution in percentage in tidal volume (%).","Data Collection Points: Baseline (before Salbutamol administration) during HFNC therapy. Post-Salbutamol: 10 minutes (early phase of response) 1 hour, 2 hours, and 3 hours after Salbutamol administration.",{"measure":28,"description":32,"timeFrame":30},"To evaluate the improvement of regional ventilation based on data obtained with EIT after the administration of salbutamol via a vibrating mesh nebulizer during HFNC in patients with AHRF. Regional Ventilation Delay (RVD) Definition: Measures the time delay in the filling of different lung regions during inhalation.\n\nUnit: Milliseconds (ms) or as a percentage of the respiratory cycle.",{"measure":28,"description":34,"timeFrame":30},"To evaluate the improvement of regional ventilation based on data obtained with EIT after the administration of salbutamol via a vibrating mesh nebulizer during HFNC in patients with AHRF. Center of Ventilation (CoV) Definition: Describes the gravity-dependent distribution of ventilation from ventral (front) to dorsal (back) lung regions.\n\nUnit: Percentage (%), representing the shift in ventilation",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":35,"primaryPurpose":39,"observationalModel":35,"timePerspective":35,"maskingInfo":40},"NA","SINGLE_GROUP","TREATMENT",{"masking":41,"maskingDescription":35,"whoMasked":35},"NONE","To evaluate the patient's respiratory effort, the pressure-time product (PTPes) and the delta of Pes oscillations during inspiration (∆ Pes) will be obtained from the analysis of the Pes curve. Global and regional pulmonary tidal volumes will be evaluated with EIT.",[44],{"label":45,"type":46,"description":47,"interventionNames":48},"Salbutamol","EXPERIMENTAL","All patients will received ventilatory support with HFNC by adjusting gas flows to 30 L\u002Fmin with 100% relative humidity, heated to 37 C, adjusting FiO2 levels to maintain SpO2 between 92 and 96%. After 20 min, each patient remaining on ventilatory support with HFNC will receive administration of salbutamol 2.5 mg via the vibrating mesh nebulizer (VMN) (Aerogen Solo®, Aerogen Ltd., Galway, Ireland) positioned immediately downstream of the humidification chamber of the HFNC system, using the dedicated connector.",[49],"Drug: salbutamol 2.5 mg via vibrating mesh nebulizer (VMN)",[51],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":35},"DRUG","salbutamol 2.5 mg via vibrating mesh nebulizer (VMN)","To evaluate the patient's respiratory effort, the pressure-time product (PTPes) and the delta of Pes oscillations during inspiration (∆ Pes) will be obtained from the analysis of the Pes curve. Global and regional pulmonary tidal volumes will be evaluated with Electrical Impedance Tomography",[45],[57],{"name":58,"affiliation":5,"role":59},"Carlo Alberto Volta, Professor","PRINCIPAL_INVESTIGATOR",[61,66],{"name":62,"role":63,"phone":64,"phoneExt":35,"email":65},"Savino Spadaro, Associate professor","CONTACT","+39 0532 293111","spdsvn@unife.it",{"name":58,"role":63,"phone":35,"phoneExt":35,"email":67},"vlc@unife.it",[69],{"facility":70,"status":35,"city":71,"state":35,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Azienda ospedaliera Universitaria di Ferrara","Ferrara","44121","Italy","IT",{"type":76,"coordinates":77},"Point",[78,79],11.62057,44.83804,{"lat":79,"lon":78},[82],{"name":83,"role":63,"phone":35,"phoneExt":35,"email":65},"Savino Spadaro, Associate Professor",{"type":59,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Savino Spadaro","Professor",[88],{"name":89,"class":90},"Aerogen","INDUSTRY","100578775",false,"NCT06815679","Physiological Effects of Nebulized Salbutamol in Acute Respiratory Failure Patients on HFNC","The Physiological Effects of Nebulized Salbutamol in Patients With Acute Respiratory Failure During HFNC","PENSAFE-HFNC","Inclusion Criteria:\n\n* • Age \\> 18, \\\u003C 90 years\n\n  * Non-intubated critically ill patients with AHRF due to pneumonia (diagnosis is based on the presence of infiltrates on chest X-ray and the onset of clinical signs of infection less than 7 days earlier)\n  * PaO2\u002FFiO2 ≤ 300 mmHg\n  * Patients receiving oxygen therapy\n\nExclusion Criteria:\n\n* • Age \\\u003C 18 years\n\n  * Hypercapnia (PaCO2 \\> 50 mmHg)\n  * Hemodynamic instability (Systolic blood pressure \\\u003C 90 mmHg or Mean arterial pressure \\\u003C 60 or high dose of vasoactive drugs)\n  * Tachycardia or tachyarrhythmia (HR \\> 130 b\u002Fmin)\n  * Known allergy or intolerance to salbutamol\n  * Patient has received inhaled therapy with short-acting beta 2 agonists \\\u003C 8 hours before or with long-acting beta 2 agonists \\\u003C 24 hours before\n  * Acute exacerbation of COPD or bronchial asthma\n  * Cardiogenic pulmonary edema\n  * GCS ≤ 12\n  * Contraindication for EIT (e.g. ICD)\n  * Pregnancy\n  * Patient refuses to participate","ALL","18 Years","90 Years",{"count":102,"type":103},20,"ESTIMATED","INTERVENTIONAL",[106,107],"PHASE2","PHASE3","This is a prospective physiological interventional study that assess the feasibility and safety of administering salbutamol using a vibrating mesh nebulizer during HFNC in patients with acute hypoxemic respiratory failure (AHRF). We evaluate whether this method of salbutamol delivery can reduce inspiratory effort and improve global and regional lung ventilation in AHRF patients. To achieve this, the study will record and analyze the following: esophageal pressure (Pes) curves, global and regional tidal volumes, minute ventilation, and changes in global and regional lung ventilation assessed through Electrical Impedance Tomography (EIT).",[110,111],"Acute Respiratory Failure","Pneumonia",[113,114,115,116],"salbutamol","acute respiratory failure","high flow nasal cannalae","aerosol delivery","NOT_YET_RECRUITING","2025-02-03",{"date":120,"type":121},"2025-02-07","ACTUAL",{"date":123,"type":103},"2025-03-01",{"date":125,"type":103},"2026-07",{"name":5,"class":6},1]