[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06805838":3,"trial-entities:NCT06805838":84,"trial-summary:NCT06805838":88},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":40,"secondary_outcomes":47,"sex":51,"minimum_age":52,"maximum_age":16,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":63,"locations":66,"central_contacts":76,"overall_officials":77,"references":82,"see_also_links":83},"NCT06805838","DoD Ventilation Study","Prolonged Manual Ventilation Simulation","ENROLLING_BY_INVITATION","2026-07-31","2025-02","2025-08-28","2025-01-25","SafeBVM","INDUSTRY",false,"A pilot study on simulated lung scenarios using the standard manual resuscitator bag, flow limiting resuscitator bag, and an FDA approved flow rate limiting device paired with a standard manual resuscitator.",null,[18],"Manual Ventilation",[20,21,22,23,24,25],"Prolonged manual ventilation simulation","BVM","Sotair","BLS certification","tidal volume","peak inspiratory pressure","INTERVENTIONAL","BASIC_SCIENCE",[29],"NA",{"count":31,"type":32},102,"ESTIMATED",[34],{"type":35,"name":22,"description":36,"armGroupLabels":37},"DEVICE","The device is a durable plastic connector with a silicone flap inside it requiring no special handling. There are no patients involved, only a simulated lung that also requires no special handling. Adult Sotair® device has FDA clearance as a Class II device through the 510(k) pathway (K212905) for the intended use of \"Flow-limiting, safe, and optimal manual ventilation to minimize gastric insufflation.\"",[38,39],"Ambu + Sotair + Low compliance","Ambu + Sotair + Normal lung compliance",[41,45],{"measure":42,"description":43,"timeFrame":44},"Minute ventilation while manually ventilating the simulated lung","The primary Ventilation endpoint is minute ventilation while manually ventilating the simulated lung over the course of 10 hours.","10 hours of manual ventilation",{"measure":42,"description":46,"timeFrame":44},"The major endpoints of the subjects response to performing the manual ventilation will be: Respiratory rate and heart rate; Samn-Perelli 7-point fatigue scale reported hourly; Modified Borg Rating of Perceived Exertion 10-point scale reported hourly.",[48],{"measure":49,"description":50,"timeFrame":44},"Secondary Outcome Measure","Secondary endpoints include: tidal volume, peak inspiratory pressure, respiratory rate, and estimated alveolar ventilation while ventilating the simulated lung.","ALL","18 Years",true,{"inclusion":55,"exclusion":59,"raw_text":62},[56,57,58],"18 years old or older","Have a current basic life support (BLS) certification","Be available for the entire 10 hours to complete the protocol",[60,61],"Any training in medical school or respiratory therapy school","Not being available for the full 10 hours to complete the protocol","Inclusion Criteria:\n\n* 18 years old or older\n* Have a current basic life support (BLS) certification\n* Be available for the entire 10 hours to complete the protocol\n\nExclusion Criteria:\n\n* Any training in medical school or respiratory therapy school\n* Not being available for the full 10 hours to complete the protocol",[64,65],"ADULT","OLDER_ADULT",[67],{"facility":68,"city":69,"state":70,"zip":71,"country":72,"geoPoint":73},"Brown Physicians, Inc","Providence","Rhode Island","02903","United States",{"lat":74,"lon":75},41.82399,-71.41283,[],[78],{"name":79,"affiliation":80,"role":81},"Mark Brady, MD","Brown Physicians, Inc.","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":85,"biomarkers":87},[86],"Manual Ventilation Simulation",[],{"nct_id":4,"found":14,"summary":16,"prompt_version":16}]