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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Direct removal of endotracheal tube
Procedure/SurgeryPatient will have direct removal of ETT and transferred to PACU breathing independently or with a face mask.
Laryngeal mask airway inserted following deep extubation
Procedure/SurgeryPatient will have LMA inserted following deep extubation of endotracheal tube.
Treatment groups
1,400 Participants
are divided into 2 treatment groupsGroup A: Group ETT direct removalActive comparator 1 intervention
Group B: Group LMA exchangeActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
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.
Time frame
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
1
Compare the rate of specific perioperative respiratory adverse events in children following either (1) direct 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 (\<95% SpO2 for more than 10 seconds on pulse oximetry), airway obstruction, severe coughing, post-operative stridor. Each individual PRAE (laryngospasm, bronchospasm, desaturation, airway obstruction, severe persistent coughing and post-operative stridor) will be considered separately.
Time frame
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)2
Compare the rate of required post-operative airway interventions in children following either (1) direct removal of ETT or (2) exchange of ETT for LMA followed by awake removal of LMA
Airway interventions are defined as: requirement for jaw thrust after airway removal, CPAP, supplemental O2 for over 10 min after the airway has been removed awake, need to reinsert LMA or ETT, use of airway adjuncts (e.g. guedel once airway removed), need for propofol or muscle relaxant following airway removal.
Time frame
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 recorded3
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)
PAED scale ranges from 0 to 20, a score of 0 is equivalent to no delirium and 20 is significant delirium
Time frame
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.4
Comparison of pain scores 5 and 20 min post airway removal (ETT in the direct removal ETT group and LMA removal in the exchange group) between the two groups
Pain will be assessed by the PACU nurse by asking the patient to rate their pain on a scale of 0 to 10, where 0 is no pain and 10 is worst possible pain.
Time frame
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov