[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100263449":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":62,"centralContacts":67,"locations":77,"responsibleParty":98,"collaborators":101,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":107,"sex":113,"minAge":114,"maxAge":32,"enrollmentInfo":115,"targetDuration":32,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":32,"overallStatus":80,"whyStopped":32,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Milton S. Hershey Medical Center","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"ETT only","ACTIVE_COMPARATOR","Endotracheal tube intubation after induction of anesthesia. Ventilation with ETT until emergence.",[13,14,15,16,17],"Procedure: Induction of anesthesia","Device: Laryngoscopy and placement of ETT","Procedure: Ventilation via the ETT","Procedure: Removal of the ETT","Procedure: Emergence from anesthesia",{"label":19,"type":20,"description":21,"interventionNames":22},"Combined ETT\u002FLMA technique","EXPERIMENTAL","Placement of LMA after induction of anesthesia. Intubation of trachea with ETT via LMA with fiberoptic bronchoscope. Ventilation with ETT throughout case. Removal of ETT while deeply anesthetized. Ventilation with LMA until emergence.",[13,23,15,16,24,25,17],"Device: Placement of LMA [Ambu (R) AuraGain (TM) disposable laryngeal mask]","Procedure: Intubation of the trachea through the LMA","Procedure: Ventilation via the LMA",[27,33,38,42,46,50,54,58],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"PROCEDURE","Induction of anesthesia","At the discretion of the primary anesthesiologist. Typically involves the administration of an analgesic agent, hypnotic agent, and neuromuscular blocking agent",[19,9],null,{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":32},"DEVICE","Placement of LMA [Ambu (R) AuraGain (TM) disposable laryngeal mask]","By standard method. Sizing at the discretion of the primary anesthesiologist.",[19],{"type":34,"name":39,"description":40,"armGroupLabels":41,"otherNames":32},"Laryngoscopy and placement of ETT","Via direct or indirect laryngoscopy. Sizing at the discretion of the primary anesthesiologist. Mallinckrodt (TM) Intermediate Hi-Lo cuffed endotracheal tube (Covidien)",[9],{"type":28,"name":43,"description":44,"armGroupLabels":45,"otherNames":32},"Ventilation via the ETT","Ventilator mode, tidal volume\u002F ventilation pressure, respiratory rate, positive end expiratory pressure, inspired to expired ratio at the discretion of the primary anesthesiologist.",[19,9],{"type":28,"name":47,"description":48,"armGroupLabels":49,"otherNames":32},"Removal of the ETT","Either upon emergence of anesthesia after suctioning of the oropharynx and after a positive pressure breath or while deeply anesthetized after release of the pneumoperitoneum in the combined LMA\u002FETT group.",[19,9],{"type":28,"name":51,"description":52,"armGroupLabels":53,"otherNames":32},"Intubation of the trachea through the LMA","With ETT using fiberoptic bronchoscope guidance.",[19],{"type":28,"name":55,"description":56,"armGroupLabels":57,"otherNames":32},"Ventilation via the LMA","After removal of the ETT. Ventilator mode, tidal volume\u002F ventilation pressure, respiratory rate, positive end expiratory pressure, inspired to expired ratio at the discretion of the primary anesthesiologist.",[19],{"type":28,"name":59,"description":60,"armGroupLabels":61,"otherNames":32},"Emergence from anesthesia","At the discretion of primary team. Airway device (either ETT or LMA) will be removed when patient is adequately ventilating and able to respond to commands (such as \"open your eyes\" or \"squeeze my hand\").",[19,9],[63],{"name":64,"affiliation":65,"role":66},"Arne Budde, MD","Penn State M.S. Hershey Medical Center","PRINCIPAL_INVESTIGATOR",[68,72],{"name":64,"role":69,"phone":70,"phoneExt":32,"email":71},"CONTACT","717-531-6140","abudde@pennstatehealth.psu.edu",{"name":73,"role":69,"phone":74,"phoneExt":75,"email":76},"Cynthia Reed, Bachelor of Science","717-531-0003","282465","creed@pennstatehealth.psu.edu",[78],{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Penn State Health - Hershey Medical Center","RECRUITING","Hershey","Pennsylvania","17033","United States","US",{"type":87,"coordinates":88},"Point",[89,90],-76.65025,40.28592,{"lat":90,"lon":89},[93,95,96],{"name":64,"role":69,"phone":94,"phoneExt":32,"email":71},"7175316140",{"name":64,"role":66,"phone":32,"phoneExt":32,"email":32},{"name":73,"role":97,"phone":32,"phoneExt":32,"email":32},"SUB_INVESTIGATOR",{"type":66,"investigatorFullName":99,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Taylor Anspach","Assistant Professor of Anesthesia and Perioperative Medicine",[102],{"name":103,"class":104},"Ambu A\u002FS","INDUSTRY","100263449","limiting-emergence-phenomena-after-general-anesthesia-with-combined-lma-and-ett-airway-management-technique-100263449",false,"NCT02708836","Limiting Emergence Phenomena After General Anesthesia With Combined LMA and ETT Airway Management Technique","Limiting Emergence Phenomena After General Anesthesia for Laparoscopic Surgery With Combined Laryngeal Mask Airway and Endotracheal Tube Airway Management Technique","LEPAGA","Inclusion Criteria:\n\n* ASA 1-3\n* Patients undergoing elective laparoscopic surgery\n\nExclusion Criteria:\n\n* Individuals who cannot provide consent\n* Individuals who would require translation services to provide consent\n* Prisoners\n* Parturients\n* Non-fasted patients (as per HMC Anesthesiology Department NPO policy)\n* Patients felt to be high risk for gastric reflux and pulmonary aspiration (those with gastroparesis, symptomatic GERD, etc.: at the discretion of primary anesthesia team) Those patients with anticipated difficult airway requiring maintenance of spontaneous ventilation (awake intubation)","ALL","18 Years",{"count":116,"type":117},130,"ESTIMATED","INTERVENTIONAL",[120],"NA","Emergence from general anesthesia with a laryngeal mask airway compared with an endotracheal tube has been shown to favorable with respect to limiting emergence phenomena such as coughing, straining, restlessness, and sympathetic stimulation leading to hypertension and tachycardia.\n\nMany anesthesiologists would prefer the use of an ETT to an LMA in cases in which higher ventilation pressures may be required, in those patients who are perceived to be high risk for reflux and pulmonary aspiration of gastric contents, as well as during cases that allow the anesthesiologist to have little accessibility the airway.\n\nThe aim of this study is to investigate an airway management technique that would allow for the benefits of the ETT in terms of a secure airway for the duration of the surgical procedure as well the potential for less emergence phenomena seen when emerging with an LMA.",[123],"Limit Emergence Phenomena After General Anesthesia","2026-07-16",{"date":126,"type":127},"2026-07-17","ACTUAL",{"date":129,"type":127},"2020-01-01",{"date":131,"type":117},"2028-06-01",{"name":5,"class":6},1]