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

Study acronym: BELUGA
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv4 Show 7 more changesShow less
    • Primary endpoint revised
    • Primary completion date: Jan 12, 2029 to Feb 16, 2029
    • Study completion date: Jan 30, 2029 to Feb 28, 2029
    • Start date changed from estimate of Jan 12, 2026 to Feb 6, 2026
    • Interventions: Endotracheal tube removed awake (Procedure), Laryngeal mask airway inserted following deep extubation (Procedure) to Direct removal of endotracheal tube (Procedure), Laryngeal mask airway inserted following deep extubation (Procedure)
    • Secondary endpoints revised (9)
    • Site details revised at 8 of 8 sites
  2. Start date: Nov 10, 2025 to Jan 12, 2026
    • Primary completion date: Nov 10, 2028 to Jan 12, 2029
    • Study completion date: Nov 15, 2028 to Jan 30, 2029
    v3
  3. Start date: Oct 1, 2025 to Nov 10, 2025v2 Show 4 more changesShow less
    • Primary completion date: Oct 1, 2028 to Nov 10, 2028
    • Study completion date: Oct 1, 2028 to Nov 15, 2028
    • Secondary endpoints revised (9)
    • Eligibility criteria shortened, about 2 words
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)		 Endotracheal Extubation, Airway Anesthesia, Paediatric
Enrollment 1,400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov