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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-16
SponsorTelethon Kids Institute

About this trial

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

Qualifiers

5kg and above,

presenting for elective, semi-elective or emergency surgery under general anaesthesia

With airway management planned with an endotracheal tube.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Direct removal of endotracheal tube
  • Laryngeal mask airway inserted following deep extubation

Treatment groups

1,400 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Telethon Kids Institute

Lead sponsor

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