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

NCT07204990 | Not Yet Recruiting DMC

• 1 other identifier: RGS0000007646
• Study Type: interventional
• Target: 1,400
• Locations: 6 countries
• Sites: 8

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.

Conditions

Endotracheal Extubation; Airway Anesthesia; Paediatric

Keywords

Paediatrics; Anaesthesia; Surgery; Extubation; Respiratory adverse events

Outcome Measures

Primary Outcomes (1)

• Compare the overall rate of perioperative respiratory adverse events in children following either (1) awake removal of ETT or (2) exchange of ETT for LMA followed by awake removal of LMA

  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.

  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)

Secondary Outcomes (9)

• Compare the rate of specific perioperative respiratory adverse events in children following either (1) awake removal of ETT or (2) exchange of ETT for LMA followed by awake removal of LMA

  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)

• Compare the rate of required post-operative airway interventions in children following either (1) awake removal of ETT or (2) exchange of ETT for LMA followed by awake removal of LMA

  Any airway interventions given along the course of the patient's perioperative pathway from extubation until their discharge from the post-anaesthetic care unit (PACU) will be recorded

• Comparison of postoperative delirium scores in PACU (post anaesthetic care unit)between the two groups using the Paediatric Anaesthesia Emergence Delirium (PAED) scale 10 minutes after awake (UMSS <2)

  A single measurement of using the PAED score will be taken 10 minutes after the patient is assessed to first be at a UMSS of 2 as per the PACU nurse.

• Comparison of pain scores 5 and 20 min post-awake airway removal (ETT in the awake ETT group and LMA removal in the exchange group) between the two groups

  Assessments of pain will be taken at 5 and 20 minutes after the patient is assessed to first be at a UMSS of 2 as per the PACU nurse.

• Comparison of the number of additional opioid analgesia use in PACU between the two groups

  All opioid analgesia usage from PACU admission until discharge will be recorded.

Study Arms (2)

Group ETT awake

ACTIVE COMPARATOR

ETT removal once the patient is fully awake (at least 3 of the following criteria: spontaneous tidal volume \>5ml/kg, conjugate gaze, facial grimace, eye-opening, purposeful movement)

Procedure: Endotracheal tube removed awake

Group LMA exchange

ACTIVE COMPARATOR

ETT removal deep; @ at least 1 Mac or an equivalent depth of anaesthesia (if available BIS\<60, Sedline \<50), an additional bolus of propofol (1mg/kg) maybe given if deemed appropriate/ required prior to the ETT removal. Following gentle suctioning around the ETT at the end of the case, the ETT is removed under deep anaesthesia and a LMA inserted.

Procedure: Laryngeal mask airway inserted following deep extubation

Interventions

Endotracheal tube removed awake PROCEDURE

Patient will have the ETT removed awake and transferred to PACU breathing independently or with a face mask.

Group ETT awake

Laryngeal mask airway inserted following deep extubation PROCEDURE

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

Group LMA exchange

Eligibility Criteria

• Age: 0 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Telethon Kids Institute: lead
• Uppsala University Hospital: collaborator
• Atrium Health Wake Forest Baptist: collaborator
• Children's Hospital of Philadelphia: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• University of Sao Paulo: collaborator
• Istituto Giannina Gaslini: collaborator
• Child and Adolescent Health Service - Perth: collaborator

Study Sites (8)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-4313, United States

Location

Perth Children's Hospital

Nedlands, Western Australia, 6909, Australia

Location

The Kids Research Institute Australia

Nedlands, Western Australia, 6909, Australia

Location

University of São Paulo

São Paulo, Brazil

Location

Istituto Giannina Gaslini

Genova, Italy

Location

Uppsala University Hospital

Uppsala, Sweden

Location

Bern University Hospital

Bern, Switzerland

Location

Central Study Contacts

Britta S. von Ungern-Sternberg, MD PHD

CONTACT

+618 6456 4806; britta.regli-vonungern@health.wa.gov.au

Lliana B Slevin, BSc

CONTACT

+61864564806; lliana.slevin@thekids.org.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 3, 2025
• Study Start: January 12, 2026
• Primary Completion (Estimated): January 12, 2029
• Study Completion (Estimated): January 30, 2029
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); SE (1); CH (1); BR (1); AU (2); US (2)