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

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

Interventions

PROCEDURE

Endotracheal tube removed awake

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

PROCEDURE

Laryngeal mask airway inserted following deep extubation

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

Sponsors & Collaborators

• Uppsala University Hospital

  collaborator OTHER

• Atrium Health Wake Forest Baptist

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• Insel Gruppe AG, University Hospital Bern

  collaborator OTHER

• University of Sao Paulo

  collaborator OTHER

• Istituto Giannina Gaslini

  collaborator OTHER

• Child and Adolescent Health Service - Perth

  collaborator OTHER_GOV

• Telethon Kids Institute

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

0 Years

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-12

Primary Completion

2029-01-12

Completion

2029-01-30

Countries

• United States
• Australia
• Brazil
• Italy
• Sweden
• Switzerland

Study Locations