[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636312":3},{"organization":4,"armGroups":7,"interventions":44,"overallOfficials":75,"centralContacts":80,"locations":90,"responsibleParty":112,"collaborators":50,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":122,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":50,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":92,"whyStopped":50,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Institute of Mountain Emergency Medicine","OTHER",[8,14,19,24,29,34,39],{"label":9,"type":10,"description":11,"interventionNames":12},"Nasal Cannula (NC)","EXPERIMENTAL","Preoxygenation over 3 minutes with a nasal cannula (NC) with supplemental oxygen delivered at 15 L\u002Fmin, during spontaneous breathing.",[13],"Device: Nasal cannula (NC)",{"label":15,"type":10,"description":16,"interventionNames":17},"Non-rebreather facemask (NRM)","Preoxygenation over 3 minutes with a Non-rebreather facemask (NRM) with supplemental oxygen delivered at 15 L\u002Fmin, during spontaneous breathing.",[18],"Device: Non-rebreather mask (NRM)",{"label":20,"type":10,"description":21,"interventionNames":22},"Non-rebreather facemask (NRM) plus Nasal Cannula (NC)","Preoxygenation for 3 minutes using a non-rebreather mask (NRM) combined with a nasal cannula delivering supplemental oxygen at 15 L\u002Fmin for each device, during spontaneous breathing.",[23],"Device: Non-rebreather mask (NRM) plus Nasal cannula (NC)",{"label":25,"type":10,"description":26,"interventionNames":27},"Bag valve mask (BVM)","Preoxygenation for 3 minutes using a bag-valve-mask (BVM) with supplemental oxygen delivered at 15 L\u002Fmin, during spontaneous breathing.",[28],"Device: Bag-valve mask (BVM) without PEEP",{"label":30,"type":10,"description":31,"interventionNames":32},"Bag valve mask (BVM) plus Nasal cannula (NC)","Preoxygenation for 3 minutes using a bag -valve-mask (BVM) combined with a nasal cannula delivering supplemental oxygen at 15 L\u002Fmin for each device, during spontaneous breathing.",[33],"Device: Bag-valve mask (BVM) without PEEP + nasal cannula (NC)",{"label":35,"type":10,"description":36,"interventionNames":37},"Bag valve mask (BVM) plus PEEP","Preoxygenation for 3 minutes using a bag-valve mask (BVM) with positive end-expiratory pressure (PEEP) set at 10 cmH₂O and supplemental oxygen delivered at 15 L\u002Fmin, during spontaneous breathing.",[38],"Device: Bag-valve mask (BVM) with PEEP",{"label":40,"type":10,"description":41,"interventionNames":42},"Bag valve mask (BVM) plus PEEP plus Nasal Cannula (NC)","Preoxygenation for 3 minutes using a bag-valve mask (BVM) with positive end-expiratory pressure (PEEP) set at 10 cmH₂O, combined with a nasal cannula delivering supplemental oxygen at 15 L\u002Fmin for each device, during spontaneous breathing.",[43],"Device: Bag-valve mask (BVM) with PEEP + nasal cannula (NC)",[45,51,55,59,63,67,71],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"DEVICE","Nasal cannula (NC)","Preoxygenation performed using a nasal cannula delivering supplemental oxygen at a flow rate of 15 L\u002Fmin, without the use of an additional mask or ventilation device, during spontaneous breathing.",[9],null,{"type":46,"name":52,"description":53,"armGroupLabels":54,"otherNames":50},"Non-rebreather mask (NRM)","Preoxygenation performed using a non-rebreather mask with reservoir, delivering oxygen at a flow rate of 15 L\u002Fmin. The mask is fitted to ensure an optimal seal, and participants breathe spontaneously without assisted ventilation.",[15],{"type":46,"name":56,"description":57,"armGroupLabels":58,"otherNames":50},"Non-rebreather mask (NRM) plus Nasal cannula (NC)","Preoxygenation performed using a non-rebreather mask with reservoir, delivering oxygen at a flow rate of 15 L\u002Fmin, combined with a nasal cannula delivering supplemental oxygen at 15 L\u002Fmin. The mask is fitted to ensure an optimal seal, and participants breathe spontaneously without assisted ventilation.",[20],{"type":46,"name":60,"description":61,"armGroupLabels":62,"otherNames":50},"Bag-valve mask (BVM) without PEEP","Preoxygenation performed using a bag-valve mask without a PEEP valve, delivering oxygen at a flow rate of 15 L\u002Fmin. The mask is held with a two-handed technique to ensure an airtight seal, without providing assisted ventilation, allowing spontaneous breathing.",[25],{"type":46,"name":64,"description":65,"armGroupLabels":66,"otherNames":50},"Bag-valve mask (BVM) without PEEP + nasal cannula (NC)","Preoxygenation performed using a bag-valve mask without a PEEP valve, delivering oxygen at a flow rate of 15 L\u002Fmin, combined with a nasal cannula delivering supplemental oxygen at 15 L\u002Fmin. The mask is held with a two-handed technique to ensure an airtight seal, without providing assisted ventilation, allowing spontaneous breathing.",[30],{"type":46,"name":68,"description":69,"armGroupLabels":70,"otherNames":50},"Bag-valve mask (BVM) with PEEP","Preoxygenation performed using a bag-valve mask equipped with a PEEP valve set at 10 cmH₂O, delivering oxygen at a flow rate of 15 L\u002Fmin. The mask is held with a two-handed technique to ensure an airtight seal, without assisted ventilation, during spontaneous breathing.",[35],{"type":46,"name":72,"description":73,"armGroupLabels":74,"otherNames":50},"Bag-valve mask (BVM) with PEEP + nasal cannula (NC)","Preoxygenation performed using a bag-valve mask equipped with a PEEP valve set at 10 cmH₂O, delivering oxygen at a flow rate of 15 L\u002Fmin, combined with a nasal cannula delivering supplemental oxygen at 15 L\u002Fmin. The mask is held with a two-handed technique to ensure an airtight seal, without assisted ventilation, during spontaneous breathing.",[40],[76],{"name":77,"affiliation":78,"role":79},"Simon Rauch","Eurac research, Institute of mountain emergency medicine","PRINCIPAL_INVESTIGATOR",[81,86],{"name":82,"role":83,"phone":84,"phoneExt":50,"email":85},"Giulia Roveri, MD","CONTACT","+390471055115","giulia.roveri@eurac.edu",{"name":87,"role":83,"phone":88,"phoneExt":50,"email":89},"Simon Rauch, MD, PhD","+390471055544","simon.rauch@eurac.edu",[91],{"facility":78,"status":92,"city":93,"state":94,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":103,"contacts":104},"RECRUITING","Bolzano","BZ","39100","Italy","IT",{"type":99,"coordinates":100},"Point",[101,102],11.33982,46.49067,{"lat":102,"lon":101},[105,106,107,110,111],{"name":82,"role":83,"phone":84,"phoneExt":50,"email":85},{"name":87,"role":83,"phone":88,"phoneExt":50,"email":89},{"name":108,"role":109,"phone":50,"phoneExt":50,"email":50},"Ruth Martintoni","SUB_INVESTIGATOR",{"name":87,"role":79,"phone":50,"phoneExt":50,"email":50},{"name":82,"role":79,"phone":50,"phoneExt":50,"email":50},{"type":79,"investigatorFullName":77,"investigatorTitle":113,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"MD, PhD","100636312","physiological-effects-of-different-preoxygenation-strategies-100636312",false,"NCT07564050","Physiological Effects of Different Preoxygenation Strategies","Physiological Effects of Different Preoxygenation Strategies in Adults and Children: A Comparative Study of NRM and BVM With and Without PEEP","PREOXY II","Inclusion Criteria:\n\n* Adults with an American Society of Anesthesiologists (ASA) physical status score ≤ 2\n* Children aged 5 to 12 years with an ASA physical status score ≤ 2\n* Ability (or legal guardian ability) to provide written informed consent\n\nExclusion Criteria:\n\n* Children aged \\\u003C 5 years or 13 to 18 years\n* ASA physical status score \\> 2\n* Body mass index (BMI) ≥ 30 kg\u002Fm²\n* Known airway pathology or anatomical abnormality that could affect mask fit, ventilation, or oxygenation\n* Presence of an active airway infection at the time of the study\n* Pregnancy\n* Refusal or inability to provide informed consent",true,"ALL","5 Years","75 Years",{"count":127,"type":128},30,"ESTIMATED","INTERVENTIONAL",[131],"NA","The goal of this clinical trial is to evaluate the performance and physiological effects of different preoxygenation devices in healthy adult and pediatric volunteers (children aged 5-12 years). The study aims to determine how these devices influence oxygen delivery, airway pressure, and cardiopulmonary physiology during preoxygenation.\n\nThe main questions it aims to answer are:\n\n* What fraction of inspired oxygen (FiO₂) is delivered by non-rebreather masks (NRM) compared to bag-valve masks (BVM) with and without positive end-expiratory pressure (PEEP)?\n* How do these devices differ in terms of generated PEEP, inspiratory effort, and their effects on lung ventilation and cardiac function?\n\nResearchers will compare NRM, BVM without PEEP, and BVM with PEEP (each with or without supplemental oxygen via nasal cannula) to evaluate differences in oxygenation and physiological effects.\n\nParticipants will:\n\n* Complete multiple 3-minute preoxygenation sessions using each device in randomized order\n* Breathe spontaneously through each device, with or without additional oxygen via nasal cannula\n* Undergo non-invasive monitoring of oxygen concentration (FiO₂), respiratory parameters, airway pressures, and ultrasound assessment of the lungs, diaphragm, and heart\n* Perform a brief breath-holding maneuver to assess airway pressure generation",[134],"Preoxygenation",[134,136,52,137,138,139],"Bag-valve mask (BVM)","Positive end-expiratory pressure (PEEP)","Fraction of inspired oxygen (FiO₂)","Respiratory physiology","2026-05-06",{"date":142,"type":143},"2026-05-08","ACTUAL",{"date":145,"type":128},"2026-05-23",{"date":147,"type":128},"2026-06-30",{"name":5,"class":6},1]