[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544577":3},{"organization":4,"armGroups":7,"interventions":46,"overallOfficials":52,"centralContacts":57,"locations":65,"responsibleParty":81,"collaborators":51,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":51,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":91,"minAge":92,"maxAge":51,"enrollmentInfo":93,"targetDuration":51,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":51,"overallStatus":68,"whyStopped":51,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Institute of Mountain Emergency Medicine","OTHER",[8,14,18,22,26,30,34,38,42],{"label":9,"type":10,"description":11,"interventionNames":12},"NRM - Non-rebreather mask in children 6-12 yrs","ACTIVE_COMPARATOR","Non-rebreather mask in children 6-12 yrs",[13],"Other: Preoxygenation",{"label":15,"type":10,"description":16,"interventionNames":17},"BVM with PEEP in children 6-12 yrs","Bag valve mask with positive end-expiratory pressure (PEEP) in children 6-12 yrs",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"BVM without PEEP in children 6-12 yrs","Bag valve mask without positive end-expiratory pressure (PEEP) in children 6-12 yrs",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"NRM - Non-rebreather mask in normal weight adults","Non-rebreather mask in normal weight adults",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"BVM with PEEP in normal weight adults","Bag valve mask with positive end-expiratory pressure (PEEP) in normal weight adults",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"BVM without PEEP in normal weight adults","Bag valve mask without positive end-expiratory pressure (PEEP) in normal weight adults",[13],{"label":35,"type":10,"description":36,"interventionNames":37},"NRM - Non-rebreather mask in overweight\u002Fobese adults","Non-rebreather mask in overweight\u002Fobese adults",[13],{"label":39,"type":10,"description":40,"interventionNames":41},"BVM with PEEP in overweight\u002Fobese adults","Bag valve mask with positive end-expiratory pressure (PEEP) in overweight\u002Fobese adults",[13],{"label":43,"type":10,"description":44,"interventionNames":45},"BVM without PEEP in overweight\u002Fobese adults","Bag valve mask without positive end-expiratory pressure (PEEP) in overweight\u002Fobese adults",[13],[47],{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"Preoxygenation","Preoxygenation of volunteers over 3 minutes",[15,27,39,19,31,43,9,23,35],null,[53],{"name":54,"affiliation":55,"role":56},"Simon Rauch, MD, PhD","Institute of Mountain Emergency Medicine, Eurac Research","PRINCIPAL_INVESTIGATOR",[58,62],{"name":54,"role":59,"phone":60,"phoneExt":51,"email":61},"CONTACT","00393404967398","simon.rauch@eurac.edu",{"name":63,"role":59,"phone":51,"phoneExt":51,"email":64},"Giulia Roveri, MD","giulia.roveri@eurac.edu",[66],{"facility":67,"status":68,"city":69,"state":51,"zip":51,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"TerraXCube","RECRUITING","Bolzano","Italy","IT",{"type":73,"coordinates":74},"Point",[75,76],11.33982,46.49067,{"lat":76,"lon":75},[79],{"name":80,"role":59,"phone":51,"phoneExt":51,"email":61},"Simon Rauch",{"type":82,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR","100544577","comparison-of-three-pre-oxygenation-strategies-100544577",false,"NCT06370689","Comparison of Three Pre-oxygenation Strategies","Comparison of Three Pre-oxygenation Strategies for Prehospital Anaesthesia Induction in Children, Normal Weight Adults and Obese Adults","Inclusion Criteria:\n\n* Normal-weight adults (BMI 18.5-24.9 kg\u002Fm2) with an \"American Society of Anesthesiologists Physical Status Classification System (ASA) \" score of I or II\n* Adults with a BMI 25-39.9 kg\u002Fm2 with and ASA score \\\u003C3\n* Healthy (ASA I) children aged 6-12 years\n\nExclusion Criteria:\n\n* ASA 3\n* Age \\\u003C 6 and age 12-18\n* pregnant women\n* missing informed consent\n* signs and symptoms of an acute respiratory illness on the study day",true,"ALL","6 Years",{"count":94,"type":95},45,"ESTIMATED","INTERVENTIONAL",[98],"NA","Study objective: Comparing the efficacy of three different preoxygenation strategies, i.e. non-rebreather face mask (NRM), bag-valve-mask (BVM) with and BVM without additional positive end-expiratory pressure (PEEP) in three subgroups of spontaneously breathing volunteers.\n\nStudy endpoints\n\nPrimary Endpoint:\n\nDifference in expiratory oxygen concentration (FeO2) at the end of the 3 min preoxygenation sessions.\n\nSecondary endpoints:\n\n* Difference in Oxygen Reserve Index (ORi) at the end of the 3 min preoxygenation sessions.\n* Changes in regional ventilation from baseline to 1.5 min and 3 min into the preoxygenation sessions, assessed using electrical impedance tomography (EIT)\n* Time to reaching an Oxygen Reserve Index (ORi) ≥ 0.5\n* Time to reaching an Oxygen Reserve Index (ORi) =1\n* Time to Oxygen Reserve Index (ORi) back to baseline after the 3 min preoxygenation sessions.\n\nNumber of participants 15 participants per subgroup, i.e. 45 participants in total.\n\nInclusion criteria\n\n* Normal-weight adults (body mass index, BMI 18.5-24.9 kg\u002Fm2) with an \"American Society of Anesthesiologists Physical Status Classification System (ASA) \" score of I or II\n* Adults with a BMI 25-39.9 kg\u002Fm2 with and ASA score \\\u003C3\n* Healthy (ASA I) children aged 6-12 years Exclusion criteria ASA 3, Age \\\u003C 6 and age 12-18, pregnant women, missing informed consent, signs and symptoms of an acute respiratory illness on the study day.\n\nAfter informed consent and a medical check-up, baseline measurements will be done for 10 minutes (peripheral oxygen saturation SpO2, ORI, regional ventilation). Then the participants will undergo 3 different preoxygenation sessions with the 3 interfaces (i.e. non-rebreather facemask with reservoir and a bag-valve-mask with and without PEEP) in a randomized order and a 20 min washout between the sessions. Each preoxygenation session is conducted in a supine position and will be proceeded until the measured FeO2 (end expiratory O2 fraction) reaches 90% or up to a maximum time of 3 min. Afterwards 10 min of SpO2, ORI and regional ventilation measurements will follow.",[101,102],"Emergencies","Anesthesia","2025-03-25",{"date":105,"type":106},"2025-03-28","ACTUAL",{"date":108,"type":106},"2024-05-23",{"date":110,"type":95},"2025-07-30",{"name":5,"class":6},1]