NCT07204990 BELUGA: Better to Exchange ETT for LMA Before Extubation in Children Under General Anaesthesia
| NCT ID | NCT07204990 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Telethon Kids Institute |
| Condition | Endotracheal Extubation |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,400 participants |
| Start Date | 2026-02-06 |
| Primary Completion | 2029-02-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,400 participants in total. It began in 2026-02-06 with a primary completion date of 2029-02-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07204990 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 16 Years, studying Endotracheal Extubation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07204990 currently recruiting?
Yes, NCT07204990 is actively recruiting participants. Contact the research team at britta.regli-vonungern@health.wa.gov.au for enrollment information.
Where is the NCT07204990 trial being conducted?
This trial is being conducted at Winston-Salem, United States, Philadelphia, United States, Nedlands, Australia, Nedlands, Australia and 4 additional locations.
Who is sponsoring the NCT07204990 clinical trial?
NCT07204990 is sponsored by Telethon Kids Institute. The trial plans to enroll 1,400 participants.