Better to Exchange ETT for LMA Before Extubation in Children Under General Anaesthesia
Official title: BELUGA: Better to Exchange ETT for LMA Before Extubation in Children Under General Anaesthesia
Run by Telethon Kids Institute · NCT07204990 · Data updated 2026-11-12
This study tests whether removing the endotracheal tube and using a laryngeal mask airway before the child wakes up is safer than removing the tube while awake, in children undergoing surgery under general anesthesia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Years to 16 Years |
| Sex | All |
| Enrollment | 1400 (estimated) |
| Sponsor | Telethon Kids Institute Academic / other |
| Locations | 8 sites (Winston-Salem, North Carolina and 7 other locations) |
| Status | Recruiting |
| Started | February 6, 2026 |
| Main results expected | February 16, 2029 |
| Study ends | February 28, 2029 |
| Registry record updated | June 1, 2026 |
| Trial ID | NCT07204990 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children 0-16 years old, weighing at least 5 kg, undergoing elective, semi-elective, or emergency surgery with planned endotracheal intubation.
✕Probably not a fit
Children with high risk of aspiration, known difficult airway, or requiring major airway surgery may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial compares two end-of-anesthesia extubation strategies in pediatric patients: deep extubation with immediate LMA insertion followed by awake removal after PACU arrival, versus awake extubation from the endotracheal tube. It is conducted under real-world anesthesia practice with data collection in defined weekly blocks to ensure balanced representation. The study uses a waiver of informed consent and observes standard clinical care in participating institutions. Outcomes focus on airway safety and respiratory events during emergence from anesthesia. Eligible participants are children aged 0-16 years requiring endotracheal intubation for surgery, with key exclusions including severe cardiopulmonary disease or anticipated difficult airway.
Why it matters
Potential benefit: If successful, the approach could reduce airway complications and desaturation during emergence from anesthesia in children.
How similar studies have gone: Previous research has explored awake versus deep extubation with mixed results, but this combination with subsequent LMA exchange is a newer approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Perth Children's Hospital
Nedlands, Western Australia, Australia Recruiting -
Uppsala University Hospital
Uppsala, Sweden Recruiting -
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States Not yet recruiting -
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States Not yet recruiting -
The Kids Research Institute Australia
Nedlands, Western Australia, Australia Active not recruiting -
University of São Paulo
São Paulo, Brazil Not yet recruiting
Show 2 more locations
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Istituto Giannina Gaslini
Genova, Italy Not yet recruiting -
Bern University Hospital
Bern, Switzerland Not yet recruiting
Study contacts
- Study coordinator: Britta S. von Ungern-Sternberg, MD PHD
- Email: britta.regli-vonungern@health.wa.gov.au
- Phone: +618 6456 4806
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.