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NOT YET RECRUITING
NCT07204990
NA

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

Sponsor: Telethon Kids Institute

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

0 Years - 16 Years

Study Type

INTERVENTIONAL

Enrollment

1400

Start Date

2026-01-12

Completion Date

2029-01-30

Last Updated

2025-12-01

Healthy Volunteers

No

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.

Locations (8)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Perth Children's Hospital

Nedlands, Western Australia, Australia

The Kids Research Institute Australia

Nedlands, Western Australia, Australia

University of São Paulo

São Paulo, Brazil

Istituto Giannina Gaslini

Genova, Italy

Uppsala University Hospital

Uppsala, Sweden

Bern University Hospital

Bern, Switzerland