[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608702":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":176,"collaborators":178,"id":191,"slug":192,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":193,"sex":198,"minAge":199,"maxAge":200,"enrollmentInfo":201,"targetDuration":25,"studyType":204,"phases":205,"briefSummary":207,"conditions":208,"keywords":212,"overallStatus":80,"whyStopped":25,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":227},{"fullName":5,"class":6},"Telethon Kids Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group ETT direct removal","ACTIVE_COMPARATOR","ETT removal once the patient is fully awake (at least 3 of the following criteria:\n\nspontaneous tidal volume \\>5ml\u002Fkg, conjugate gaze, small pupils facial grimace, movement other than coughing, swallowing, oxygen saturations greater than 95%. eye-opening, purposeful movement). A bolus of propofol can be given up to 1mg\u002Fkg.",[13],"Procedure: Direct removal of endotracheal tube",{"label":15,"type":10,"description":16,"interventionNames":17},"Group LMA exchange","ETT removal deep; @ at least 1 Mac or an equivalent depth of anaesthesia (if available BIS\\\u003C60, Sedline \\\u003C50), an additional bolus of propofol (1mg\u002Fkg) maybe given if deemed appropriate\u002F required prior to the ETT removal. Following gentle suctioning around the ETT at the end of the case, the ETT is removed under deep anaesthesia and a LMA inserted.",[18],"Procedure: Laryngeal mask airway inserted following deep extubation",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Direct removal of endotracheal tube","Patient will have direct removal of ETT and transferred to PACU breathing independently or with a face mask.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Laryngeal mask airway inserted following deep extubation","Patient will have LMA inserted following deep extubation of endotracheal tube.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Britta S. von Ungern-Sternberg, MD PHD","CONTACT","+618 6456 4806","britta.regli-vonungern@health.wa.gov.au",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Lliana B Slevin, BSc","+61864564806","lliana.slevin@thekids.org.au",[41,62,78,106,112,128,144,160],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Atrium Health Wake Forest Baptist","NOT_YET_RECRUITING","Winston-Salem","North Carolina","27157","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-80.24422,36.09986,{"lat":53,"lon":52},[56,60],{"name":57,"role":33,"phone":58,"phoneExt":25,"email":59},"Thomas Templeton, MD","+1(336)575-5712","ttemplet@wakehealth.edu",{"name":57,"role":61,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"facility":63,"status":43,"city":64,"state":65,"zip":66,"country":47,"countryCode":48,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"The Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104-4313",{"type":50,"coordinates":68},[69,70],-75.16362,39.95238,{"lat":70,"lon":69},[73,77],{"name":74,"role":33,"phone":75,"phoneExt":25,"email":76},"Annery Garcia-Marcinkiewicz, MD","+1(646)5414638","garciamara@chop.edu",{"name":74,"role":61,"phone":25,"phoneExt":25,"email":25},{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Perth Children's Hospital","RECRUITING","Nedlands","Western Australia","6909","Australia","AU",{"type":50,"coordinates":87},[88,89],115.8073,-31.98184,{"lat":89,"lon":88},[92,94,95,98,100,102,104],{"name":93,"role":33,"phone":34,"phoneExt":25,"email":35},"Britta S von Ungern-Sternberg, MD PHD",{"name":37,"role":33,"phone":25,"phoneExt":25,"email":39},{"name":96,"role":97,"phone":25,"phoneExt":25,"email":25},"David Sommerfield, MD","SUB_INVESTIGATOR",{"name":99,"role":97,"phone":25,"phoneExt":25,"email":25},"Neil Hauser, MD",{"name":101,"role":97,"phone":25,"phoneExt":25,"email":25},"Nazim Khan, PhD",{"name":103,"role":97,"phone":25,"phoneExt":25,"email":25},"Heather Patterson, MD",{"name":105,"role":97,"phone":25,"phoneExt":25,"email":25},"Chloe Heath, MD",{"facility":107,"status":108,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":109,"geoPoint":111,"contacts":25},"The Kids Research Institute Australia","ACTIVE_NOT_RECRUITING",{"type":50,"coordinates":110},[88,89],{"lat":89,"lon":88},{"facility":113,"status":43,"city":114,"state":25,"zip":25,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"University of São Paulo","São Paulo","Brazil","BR",{"type":50,"coordinates":118},[119,120],-46.63611,-23.5475,{"lat":120,"lon":119},[123,127],{"name":124,"role":33,"phone":125,"phoneExt":25,"email":126},"Vinícius C Quintão, MD PHD","+55(11)97127-3950","vinicius.quintao@hc.fm.usp.br",{"name":124,"role":61,"phone":25,"phoneExt":25,"email":25},{"facility":129,"status":43,"city":130,"state":25,"zip":25,"country":131,"countryCode":132,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Istituto Giannina Gaslini","Genova","Italy","IT",{"type":50,"coordinates":134},[135,136],11.87211,45.21604,{"lat":136,"lon":135},[139,143],{"name":140,"role":33,"phone":141,"phoneExt":25,"email":142},"Nicola Disma, MD","+393382758043","nicoladisma@gmail.com",{"name":140,"role":61,"phone":25,"phoneExt":25,"email":25},{"facility":145,"status":80,"city":146,"state":25,"zip":25,"country":147,"countryCode":148,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Uppsala University Hospital","Uppsala","Sweden","SE",{"type":50,"coordinates":150},[151,152],17.63889,59.85882,{"lat":152,"lon":151},[155,159],{"name":156,"role":33,"phone":157,"phoneExt":25,"email":158},"Peter Frykholm, MD PHD","+46708454969","peter.frykholm@uu.se",{"name":156,"role":61,"phone":25,"phoneExt":25,"email":25},{"facility":161,"status":43,"city":162,"state":25,"zip":25,"country":163,"countryCode":164,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Bern University Hospital","Bern","Switzerland","CH",{"type":50,"coordinates":166},[167,168],7.44744,46.94809,{"lat":168,"lon":167},[171,175],{"name":172,"role":33,"phone":173,"phoneExt":25,"email":174},"Thomas Riva, MD","+41764211409","thomasriva@me.com",{"name":172,"role":61,"phone":25,"phoneExt":25,"email":25},{"type":177,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[179,180,181,183,185,187,188],{"name":145,"class":6},{"name":42,"class":6},{"name":182,"class":6},"Children's Hospital of Philadelphia",{"name":184,"class":6},"Insel Gruppe AG, University Hospital Bern",{"name":186,"class":6},"University of Sao Paulo",{"name":129,"class":6},{"name":189,"class":190},"Child and Adolescent Health Service - Perth","OTHER_GOV","100608702","beluga-better-to-exchange-ett-for-lma-before-extubation-in-children-under-general-anaesthesia-100608702",false,"NCT07204990","BELUGA: Better to Exchange ETT for LMA Before Extubation in Children Under General Anaesthesia","BELUGA","Participant Inclusion Criteria\n\n* Children 0-16 years,\n* 5kg and above,\n* presenting for elective, semi-elective or emergency surgery under general anaesthesia\n* With airway management planned with an endotracheal tube.\n\nExclusion Criteria:\n\n* Children with severe cardiopulmonary disease or syndrome\n* Children \\\u003C 5kg\n* Children with a contraindication to deep removal of ETT deep or exchange of ETT to LMA at the end of the case (e.g. high risk of aspiration)\n* Children with a known or anticipated difficult airway\n* Children remaining intubated post-procedure\n* Children undergoing major airway surgery or bronchoscopies","ALL","0 Years","16 Years",{"count":202,"type":203},1400,"ESTIMATED","INTERVENTIONAL",[206],"NA","During surgery, anaesthetists can use an endotracheal tube (ETT) to facilitate ventilation. At emergence from general anaesthesia, there are two techniques for removal of the ETT: (1) the ETT is removed when the child is waking up in (awake removal); or (2) the ETT is removed while still under anaesthesia(deep removal).\n\nCurrently there is no evidence to suggest either technique is safer - deep removal of the ETT may decrease the risk of overall airway complications, including cough and desaturations. However, it may be associated with increased airway obstruction compared with awake extubation in paediatric patients. In our institution, a further technique has become increasingly common practice: removing ETT deep to avoid coughing and desaturation, then inserting a laryngeal mask airway (LMA) which can be removed once the patient is awake in the postoperative care unit (PACU), avoiding the risk of airway obstruction coupled with deep airway removal. The aim of the study is to assess whether deep removal of an ETT and exchange to an LMA, is superior to awake ETT removal with regards to the occurrence of postoperative respiratory adverse events.\n\nIn this study, patients will be randomised to awake removal of ETT or deep removal of an ETT and exchange to an LMA. Data will be collected regarding the rate of respiratory adverse events in either group, as well as the incidence of post-operative pain, delirium and nausea and vomiting.",[209,210,211],"Endotracheal Extubation","Airway Anesthesia","Paediatric",[213,214,215,216,217],"Paediatrics","Anaesthesia","Surgery","Extubation","Respiratory adverse events","2026-05-28",{"date":220,"type":221},"2026-06-01","ACTUAL",{"date":223,"type":221},"2026-02-06",{"date":225,"type":203},"2029-02-28",{"name":5,"class":6},8]