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BELUGA: Airway Management in Children After Anesthesia

This study, called BELUGA, is looking at the best way to remove a breathing tube (endotracheal tube or ETT) in children aged 0 to 16 after general anesthesia. Doctors are comparing two methods: either removing the ETT directly, or replacing it with a laryngeal mask airway (LMA) before the child fully wakes up. The goal is to see which method leads to fewer breathing problems after surgery. They plan to enroll 1400 children who weigh 5kg or more and are having elective, semi-elective, or emergency surgery. Children with severe heart or lung conditions, or those under 5kg, cannot participate. The study will consider the treatment successful if it reduces breathing issues from extubation until discharge from the recovery room (PACU). The current status of this study is unclear.

Study design
This is an interventional study comparing two different procedures for airway management. It aims to enroll 1400 children.
What's involved
Children participating will receive either direct removal of their endotracheal tube or have it exchanged for a laryngeal mask airway. All clinical care will follow standard institutional practices.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored from extubation until their discharge from the post-anesthetic care unit (PACU).

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NCT07204990

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

Recruiting
NAAges 0–16InterventionalPrevention
Telethon Kids Institute
~1,400 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Direct removal of endotracheal tubeLaryngeal mask airway inserted following deep extubation

At a glance

Recruiting sites
2 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over 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)

Conditions

Endotracheal Extubation
Airway Anesthesia
Paediatric

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Surgical Procedure

Where it's being run

8 sites across 7 states
Western Australia2
North Carolina1
Pennsylvania1
Brazil1
Italy1
Sweden1
Switzerland1

Who to contact

Britta S. von Ungern-Sternberg, MD PHD
[email protected]
+618 6456 4806
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Eligibility criteria

Inclusion

Children 0-16 years,
5kg and above,
presenting for elective, semi-elective or emergency surgery under general anaesthesia
With airway management planned with an endotracheal tube.

Exclusion

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

What this trial measures

  • 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 LMAAssessed by the anaesthetist along the course of the patient's perioperative pathway from extubation until their discharge from the post-anaesthetic care unit (PACU)

    Perioperative respiratory adverse events (PRAE) are defined as: Major PRAE: laryngospasm or bronchospasm, as determined by the anaesthetist, or desaturation \<85% SpO2 for more than 1 minute on pulse oximetry. Minor PRAE: desaturation (\<85% SpO2 for more than 10 secs on pulse oximetry), airway obstruction, severe coughing, post-operative stridor.