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

Recruiting now · Not applicable

Conditions studied: Endotracheal Extubation, Airway Anesthesia, Paediatric

In brief

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 facts

Study ID

NCT07204990

Run by

Telethon Kids Institute

People needed

1400

Starts

2026-02-06

Expected to finish

2029-02-28

Last updated by the study team

2026-06-01

Who can join

Age: any, up to 16. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Children with severe cardiopulmonary disease or syndrome
• Children < 5kg
• 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)
• Children with a known or anticipated difficult airway
• Children remaining intubated post-procedure
• Children undergoing major airway surgery or bronchoscopies

Where it is running

• Uppsala University Hospital — Uppsala, Sweden (enrolling)
• Perth Children's Hospital — Nedlands, Western Australia, Australia (enrolling)
• The Kids Research Institute Australia — Nedlands, Western Australia, Australia
• University of São Paulo — São Paulo, Brazil
• Istituto Giannina Gaslini — Genova, Italy
• Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States
• Bern University Hospital — Bern, Switzerland
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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