[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525126":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":41,"responsibleParty":58,"collaborators":18,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":18,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":18,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":43,"whyStopped":18,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Rhode Island Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bag mask ventilation with Adult Sotair device","ACTIVE_COMPARATOR","The anesthesia provider will manually bag ventilate with the Adult Sotair® device for 3 minutes.",[13],"Device: ADULT Sotair Device",{"label":15,"type":16,"description":17,"interventionNames":18},"Mechanical Ventilation","NO_INTERVENTION","The anesthesia provider will remove the bag valve mask and Adult Sotair® device and connect the patient to the mechanical ventilator. The recording of pressure and flow will last for 3 minutes.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","ADULT Sotair Device","Sotair® device employs a flow limiting and pressure control valve mechanism.",[9],[26,27],"Sotair","SafeBVM",[29],{"name":30,"affiliation":5,"role":31},"Mark Kendall, MD","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},"Stephanie Farias","CONTACT","401-444-5172","stephanie.farias@lifespan.org",{"name":39,"role":35,"phone":18,"phoneExt":18,"email":40},"Mark Brady, MD","mark.brady@brownphysicians.org",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Providence","Rhode Island","02903","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-71.41283,41.82399,{"lat":53,"lon":52},[56],{"name":30,"role":35,"phone":36,"phoneExt":18,"email":57},"mark.kendall@lifespan.org",{"type":31,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Mark Kendall","Director of Clinical Research","100525126","non-inferiority-trial-between-sotair-device-attached-to-manual-resuscitator-versus-mechanical-ventilation-100525126",false,"NCT06117683","Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation","Non-inferiority Comparative Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation in Patients Undergoing Non-emergent Surgery With General Anesthesia","Inclusion Criteria:\n\n* Adult patients who are scheduled for non-emergency surgery with general anesthesia at Rhode Island Hospital.\n* American Society of Anesthesiologists physical status 1 and 2\n\nExclusion Criteria:\n\n* ASA PS \\>3 (e.g., respiratory disease)\n* Oropharyngeal or facial pathology","ALL","18 Years","80 Years",{"count":72,"type":73},310,"ESTIMATED","INTERVENTIONAL",[76],"NA","Effective respiratory ventilation is achieved by moving the right amount of air in and out of the lungs while keeping the pressures at a safe level. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery. In this non-inferiority study, we will perform a pre-post study design (single group, within-group comparison) to test the non-inferiority of the Adult Sotair® device compared to mechanical ventilation.",[79,80],"Airway Management","Respiration, Artificial",[15,82,83,84],"General Anesthesia","Bag Mask Ventilation","Adult Sotair Device","2025-07-09",{"date":87,"type":88},"2025-07-11","ACTUAL",{"date":90,"type":88},"2023-12-20",{"date":92,"type":73},"2025-07",{"name":5,"class":6},1]