BELUGA: Better to Exchange ETT for LMA Before Extubation in Children Under General Anaesthesia

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). Currently 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. In 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.

NCT Number	NCT07204990
Lead Sponsor	Telethon Kids Institute Collaborators: Uppsala University Hospital, Atrium Health Wake Forest Baptist, Children's Hospital of Philadelphia, Insel Gruppe AG, University Hospital Bern, University of Sao Paulo, Istituto Giannina Gaslini, Child and Adolescent Health Service - Perth
Conditions	Endotracheal Extubation, Airway Anesthesia, Paediatric
Enrollment	1,400 participants
Start Date	2026-02-06
Primary Completion	2029-02-16 (estimated)
Study Completion	2029-02-28 (estimated)
Updated on ClinicalTrials.gov	2026-06-01