Clinical trial Recruiting at 2 sites Interventional Ages 0 to 16

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.

More Airway Complication of Anesthesia trials

Quick facts

Study typeInterventional
Ages0 Years to 16 Years
SexAll
Enrollment1400 (estimated)
SponsorTelethon Kids Institute
Academic / other
Locations8 sites (Winston-Salem, North Carolina and 7 other locations)
StatusRecruiting
StartedFebruary 6, 2026
Main results expectedFebruary 16, 2029
Study endsFebruary 28, 2029
Registry record updatedJune 1, 2026
Trial IDNCT07204990 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
  • Istituto Giannina Gaslini
    Genova, Italy
    Not yet recruiting
  • Bern University Hospital
    Bern, Switzerland
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.