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Clinical Trials in Australia / NCT07204990
Recruiting Not applicable

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

NCT07204990 · tracked via the Priya Life Science Australia tracker
Phase
Not applicable
Started
2026-02-06
Last updated
2026-06-01

Condition(s) studied

Endotracheal ExtubationAirway AnesthesiaPaediatric

Investigational drug(s) / intervention(s)

Direct removal of endotracheal tubeLaryngeal mask airway inserted following deep extubation

Direct removal of endotracheal tube: 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: Patient will have LMA inserted following deep extubation of endotracheal tube.

Study 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.

Eligibility

Sex
ALL
Min age
0 Years
Max age
16 Years
Healthy volunteers
No
Participant Inclusion Criteria * 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 Criteria: * 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

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Atrium Health Wake Forest Baptist Winston-Salem North Carolina Not Yet Recruiting
The Children's Hospital of Philadelphia Philadelphia Pennsylvania Not Yet Recruiting
Perth Children's Hospital Nedlands Western Australia Recruiting
The Kids Research Institute Australia Nedlands Western Australia Active Not Recruiting
University of São Paulo São Paulo Brazil Not Yet Recruiting
Istituto Giannina Gaslini Genova Italy Not Yet Recruiting
Uppsala University Hospital Uppsala Sweden Recruiting
Bern University Hospital Bern Switzerland Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07204990 on ClinicalTrials.gov ↗ ← All trials in Australia