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

Condition(s) studied

Investigational drug(s) / intervention(s)

Direct removal of endotracheal tube: Patient will have direct removal of ETT and transferred to PACU breathing independently or with a face mask.

Laryngeal mask airway inserted following deep extubation: Patient will have LMA inserted following deep extubation of endotracheal tube.

Study 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.

Eligibility

Primary outcome measure(s)

• Compare the overall rate of perioperative respiratory adverse events in children following either (1) directly at the end of surgery 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)
  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.

Trial sites (8)