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BELUGA: Better to Exchange ETT for LMA Before Extubation in Children Under General Anaesthesia
Sponsor: Telethon Kids Institute
Summary
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.
Key Details
Gender
All
Age Range
0 Years - 16 Years
Study Type
INTERVENTIONAL
Enrollment
1400
Start Date
2026-01-12
Completion Date
2029-01-30
Last Updated
2025-12-01
Healthy Volunteers
No
Interventions
Endotracheal tube removed awake
Patient will have the ETT removed awake and transferred to PACU breathing independently or with a face mask.
Laryngeal mask airway inserted following deep extubation
Patient will have LMA inserted following deep extubation of endotracheal tube.
Locations (8)
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Perth Children's Hospital
Nedlands, Western Australia, Australia
The Kids Research Institute Australia
Nedlands, Western Australia, Australia
University of São Paulo
São Paulo, Brazil
Istituto Giannina Gaslini
Genova, Italy
Uppsala University Hospital
Uppsala, Sweden
Bern University Hospital
Bern, Switzerland