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

Conditions

• Airway Anesthesia
• Endotracheal Extubation
• Paediatric

Eligibility Criteria

Sex

ALL

Age

0 Years - 16 Years

Healthy Volunteers

Not accepted

Interventions

• Direct removal of endotracheal tube — PROCEDURE
  Patient will have direct removal of ETT and transferred to PACU breathing independently or with a face mask.
• Laryngeal mask airway inserted following deep extubation — PROCEDURE
  Patient will have LMA inserted following deep extubation of endotracheal tube.

Study Details

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 Dates

Start date

Feb 6, 2026

Status verified

Nov 2025

Primary completion

Feb 16, 2029

Completion

Feb 28, 2029

Study Design

Enrollment

1,400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: Group ETT direct removal
  ETT removal once the patient is fully awake (at least 3 of the following criteria: spontaneous tidal volume \>5ml/kg, 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/kg.
• Active Comparator: Group LMA exchange
  ETT removal deep; @ at least 1 Mac or an equivalent depth of anaesthesia (if available BIS\<60, Sedline \<50), an additional bolus of propofol (1mg/kg) maybe given if deemed appropriate/ 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.

Primary Outcome Measure

Compare the overall rate of perioperative respiratory adverse events in children following either (1) directly at the end of surgery or (2) exchange of ETT for LMA followed by awake removal of LMA [ Time Frame: Assessed by the anaesthetist along the course of the patient's perioperative pathway from extubation until their discharge from the post-anaesthetic care unit (PACU) ]

Central Contacts

• Britta S. von Ungern-Sternberg, MD PHD
  +618 6456 4806
  [email protected]
• Lliana B Slevin, BSc
  +61864564806
  [email protected]

Locations (2)

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