Endotracheal ExtubationBELUGANCT07204990
BELUGA: Better to Exchange ETT for LMA Before Extubation in Children Under General Anaesthesia
A study testing Direct removal of endotracheal tube and Laryngeal mask airway inserted following deep extubation in people with Endotracheal Extubation and Airway Anesthesia, run by Telethon Kids Institute at 8 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 16 years
- Conditions the study is for
- Endotracheal Extubation, Airway Anesthesia, Paediatric
- What is being tested?
- Direct removal of endotracheal tube and Laryngeal mask airway inserted following deep extubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 6 Feb 2026to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- 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
- Children remaining intubated post-procedure
- Children undergoing major airway surgery or bronchoscopies
Trial locations and contacts
8 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 6 countries
United States2 sites, 2 recruiting
- Not yet recruiting
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4313
Annery Garcia-Marcinkiewicz, MD, +1(646)5414638, garciamara@chop.edu
Annery Garcia-Marcinkiewicz, MD
- Not yet recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Thomas Templeton, MD, +1(336)575-5712, ttemplet@wakehealth.edu
Thomas Templeton, MD
Australia2 sites, 1 recruiting
- Recruiting
Perth Children's Hospital
Nedlands, Western Australia, 6909
Britta S von Ungern-Sternberg, MD PHD, +618 6456 4806, britta.regli-vonungern@health.wa.gov.au
Lliana B Slevin, BSc, lliana.slevin@thekids.org.au
- Active, not recruiting
The Kids Research Institute Australia
Nedlands, Western Australia, 6909
Brazil1 site, 1 recruiting
- Not yet recruiting
University of São Paulo
São Paulo
Vinícius C Quintão, MD PHD, +55(11)97127-3950, vinicius.quintao@hc.fm.usp.br
Vinícius C Quintão, MD PHD
Italy1 site, 1 recruiting
- Not yet recruiting
Istituto Giannina Gaslini
Genova
Nicola Disma, MD, +393382758043, nicoladisma@gmail.com
Nicola Disma, MD
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University Hospital
Uppsala
Peter Frykholm, MD PHD, +46708454969, peter.frykholm@uu.se
Peter Frykholm, MD PHD
Switzerland1 site, 1 recruiting
- Not yet recruiting
Bern University Hospital
Bern
Thomas Riva, MD, +41764211409, thomasriva@me.com
Thomas Riva, MD
About this study
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.
Read the detailed description
Anaesthesia induction and maintenance will be performed as deemed appropriate by the attending anaesthetist. The choice and dose of analgesia will be at the discretion of the individual anaesthetist adjusted to the individual patient's needs. All clinical care will be in accordance with institutional standards.
All children undergoing surgery under general anaesthesia involving insertion of an endotracheal tube who arrive in the PCH post-anaesthetic care unit (PACU) between 0800 and 1800 on weekdays during the data collection periods will be included in this study under a waiver of consent. Surgical lists in our institution operate on four-week cycles (weeks A, B, C and D), with some surgical specialities scheduled for one list a fortnight or one list every four weeks and others having multiple lists per week. In order to ensure that both intervention groups have equal representation of each of the weeks A, B C and D, data collection will take place in 8-week blocks until such a time as the sample size has been reached.
Group ETT awake: ETT removal once the patient is fully awake (at least 3 of the following criteria: spontaneous tidal volume >5ml/kg, conjugate gaze, facial grimace, eye-opening, purposeful movement Group LMA exchange: ETT removal deep; @ at least 1 Mac or an equivalent depth of anaesthesia (if available BIS <60, Sedline <50), an additional bolus of propofol (1mg/kg) maybe given if deemed appropriate/ required prior to the ETT removal as per normal clinical practice. Following gentle suctioning around the ETT at the end of the case, the ETT is removed under deep anaesthesia and a LMA is inserted in its place.
There is no individual randomisation or blinding in this study. Extubation procedure (either ETT removed awake or ETT removed deep and exchanged for LMA) will each be used for 4 out of 8 weeks during the data collection period. The intervention assigned for the first 4-week cycle of the data collection period will be decided by the toss of a coin. Thereafter, intervention 1 (either ETT awake or LMA exchange) will be in place for weeks 4 weeks, with the alternate intervention in place for the subsequent 4 weeks. Given the nature of the intervention it is not possible to have blinding for this study. The statistical analysis will be performed by individuals blinded to the randomisation. This will be repeated until the required sample size has been reached
Demographic information routinely collected as part of normal clinical care will be recorded on a patient data sheet, including their date of birth, natal sex, height, weight, ethnicity and age on the day of surgery. Details about their condition on the day of surgery will be collected, including their American Society of Anaesthesiologists physical status (ASA) I-IV, any upper respiratory tract infections in the last two weeks, current or previous respiratory risk factors, and any signs of obstructive sleep apnoea, details of know abnormal pulse oximetry, risk factors for postoperative nausea and vomiting and any history of prematurity. Details of their anaesthetic management and their time spend in the post-anaesthetic care unit (PACU) will also be recorded, as well as any incidence of respiratory adverse events at any time from induction of anaesthesia until discharge from PACU. Incidence of sore throat or hoarse voice will be collected on the day of surgery 2-4 hours post PACU discharge.
- Conditions
- Endotracheal Extubation, Airway Anesthesia, Paediatric
- Being tested
- Direct removal of endotracheal tube, Laryngeal mask airway inserted following deep extubation
- Keywords
- Paediatrics, Anaesthesia, Surgery, Extubation, Respiratory adverse events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct removal of endotracheal tubeProcedure or surgery
Patient will have direct removal of ETT and transferred to PACU breathing independently or with a face mask.
Laryngeal mask airway inserted following deep extubationProcedure or surgery
Patient will have LMA inserted following deep extubation of endotracheal tube.
| Study group | Role | What they receive |
|---|---|---|
| Group ETT direct removal | Active comparator | ETT removal once the patient is fully awake (at least 3 of the following criteria:
spontaneous tidal volume >5ml/kg, conjugate gaze, small pupils facial grimace, movement other than coughing, swallowing, oxygen saturations greater than 95%. eye-opening, purposeful movement). A bolus of propofol can be given up to 1mg/kg. Receives: Procedure: Direct removal of endotracheal tube |
| Group LMA exchange | Active comparator | ETT removal deep; @ at least 1 Mac or an equivalent depth of anaesthesia (if available BIS<60, Sedline <50), an additional bolus of propofol (1mg/kg) maybe given if deemed appropriate/ required prior to the ETT removal. Following gentle suctioning around the ETT at the end of the case, the ETT is removed under deep anaesthesia and a LMA inserted. Receives: Procedure: Laryngeal mask airway inserted following deep extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (9)
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.
Measured: 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)
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.
Measured: 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 recorded
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
Measured: 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.
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.
Measured: 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.
Comparison of the number of additional opioid analgesia use in PACU between the two groups
Looking at the number of additional opioid analgesia patients need in each group and comparing these.
Measured: All opioid analgesia usage from PACU admission until discharge will be recorded.
Comparison of time between the end of surgery and arrival in PACU between the two groups and time to UMSS <2 (awake)
End of surgery is defined as completed application of dressing/cast (as applicable). This will be minutes to hours of time.
Measured: Time at which patient arrives in PACU and time at which their UMSS score is ≤2 will be measured by the PACU nurse during their post-operative PACU admission. Measured in minutes/hours on day of surgery for each patient.
Comparison of PACU time between the two groups
Measured: PACU time is defined as the time from arrival in PACU until ready for discharge from PACU.
To compare rates of vomiting and self-reported nausea in PACU between the two groups
Rates of vomiting will be as reported by the PACU nurse. Self-reported nausea will be recorded only in children over the age of 6 years.
Measured: Assessed from the time at which the patient is admitted to PACU until the time that they are discharged.
To compare the incidence of sore throat and hoarse voice between the two groups
Sore throat score as rated on a 4-point scale - nil, mild, moderate, severe. Hoarse voice as identified by parent and rated on a 4-point scale nil, mild, moderate, severe.
Measured: Collected on the day of surgery, 2-4 hours post discharge from PACU.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start6 Feb 2026
- Primary completion16 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal ExtubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Telethon Kids Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital, Atrium Health Wake Forest Baptist, Children's Hospital of Philadelphia, Insel Gruppe AG, University Hospital Bern, University of Sao Paulo, Istituto Giannina Gaslini, Child and Adolescent Health Service - Perth
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204990
- Sponsor's protocol ID
- RGS0000007646
- Acronym
- BELUGA
- Status last verified
- Nov 2025
- First submitted
- 24 Sep 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BELUGA: Better to Exchange ETT for LMA Before Extubation in Children Under General Anaesthesia
- ClinicalTrials.gov ID
- NCT07204990
- Acronym / sponsor ID
- BELUGA / RGS0000007646
- Conditions
- Endotracheal Extubation, Airway Anesthesia, Paediatric
- Keywords
- Paediatrics, Anaesthesia, Surgery, Extubation, Respiratory adverse events
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Telethon Kids InstituteUniversity, hospital or other
- Collaborators
- Uppsala University Hospital, Atrium Health Wake Forest Baptist, Children's Hospital of Philadelphia, Insel Gruppe AG, University Hospital Bern, University of Sao Paulo, Istituto Giannina Gaslini, Child and Adolescent Health Service - Perth
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- 16 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Anaesthesia induction and maintenance will be performed as deemed appropriate by the attending anaesthetist. The choice and dose of analgesia will be at the discretion of the individual anaesthetist adjusted to the individual patient's needs. All clinical care will be in accordance with institutional standards.
All children undergoing surgery under general anaesthesia involving insertion of an endotracheal tube who arrive in the PCH post-anaesthetic care unit (PACU) between 0800 and 1800 on weekdays during the data collection periods will be included in this study under a waiver of consent. Surgical lists in our institution operate on four-week cycles (weeks A, B, C and D), with some surgical specialities scheduled for one list a fortnight or one list every four weeks and others having multiple lists per week. In order to ensure that both intervention groups have equal representation of each of the weeks A, B C and D, data collection will take place in 8-week blocks until such a time as the sample size has been reached.
Group ETT awake: ETT removal once the patient is fully awake (at least 3 of the following criteria: spontaneous tidal volume >5ml/kg, conjugate gaze, facial grimace, eye-opening, purposeful movement Group LMA exchange: ETT removal deep; @ at least 1 Mac or an equivalent depth of anaesthesia (if available BIS <60, Sedline <50), an additional bolus of propofol (1mg/kg) maybe given if deemed appropriate/ required prior to the ETT removal as per normal clinical practice. Following gentle suctioning around the ETT at the end of the case, the ETT is removed under deep anaesthesia and a LMA is inserted in its place.
There is no individual randomisation or blinding in this study. Extubation procedure (either ETT removed awake or ETT removed deep and exchanged for LMA) will each be used for 4 out of 8 weeks during the data collection period. The intervention assigned for the first 4-week cycle of the data collection period will be decided by the toss of a coin. Thereafter, intervention 1 (either ETT awake or LMA exchange) will be in place for weeks 4 weeks, with the alternate intervention in place for the subsequent 4 weeks. Given the nature of the intervention it is not possible to have blinding for this study. The statistical analysis will be performed by individuals blinded to the randomisation. This will be repeated until the required sample size has been reached
Demographic information routinely collected as part of normal clinical care will be recorded on a patient data sheet, including their date of birth, natal sex, height, weight, ethnicity and age on the day of surgery. Details about their condition on the day of surgery will be collected, including their American Society of Anaesthesiologists physical status (ASA) I-IV, any upper respiratory tract infections in the last two weeks, current or previous respiratory risk factors, and any signs of obstructive sleep apnoea, details of know abnormal pulse oximetry, risk factors for postoperative nausea and vomiting and any history of prematurity. Details of their anaesthetic management and their time spend in the post-anaesthetic care unit (PACU) will also be recorded, as well as any incidence of respiratory adverse events at any time from induction of anaesthesia until discharge from PACU. Incidence of sore throat or hoarse voice will be collected on the day of surgery 2-4 hours post PACU discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group ETT direct removal | Active comparator | Procedure: Direct removal of endotracheal tubeETT removal once the patient is fully awake (at least 3 of the following criteria: spontaneous tidal volume >5ml/kg, conjugate gaze, small pupils facial grimace, movement other than coughing, swallowing, oxygen saturations greater than 95%. eye-opening, purposeful movement). A bolus of propofol can be given up to 1mg/kg. |
| Group LMA exchange | Active comparator | Procedure: Laryngeal mask airway inserted following deep extubationETT removal deep; @ at least 1 Mac or an equivalent depth of anaesthesia (if available BIS<60, Sedline <50), an additional bolus of propofol (1mg/kg) maybe given if deemed appropriate/ required prior to the ETT removal. Following gentle suctioning around the ETT at the end of the case, the ETT is removed under deep anaesthesia and a LMA inserted. |
Who may qualify
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
- Children remaining intubated post-procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct removal of endotracheal tubePatient will have direct removal of ETT and transferred to PACU breathing independently or with a face mask. | Procedure or surgery | Group ETT direct removal |
| Laryngeal mask airway inserted following deep extubationPatient will have LMA inserted following deep extubation of endotracheal tube. | Procedure or surgery | Group LMA exchange |
Primary outcome
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
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)
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.
9 secondary outcomes
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
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)
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
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 recorded
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)
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.
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
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.
Comparison of the number of additional opioid analgesia use in PACU between the two groups
Time frame: All opioid analgesia usage from PACU admission until discharge will be recorded.
Comparison of time between the end of surgery and arrival in PACU between the two groups and time to UMSS <2 (awake)
Time frame: Time at which patient arrives in PACU and time at which their UMSS score is ≤2 will be measured by the PACU nurse during their post-operative PACU admission. Measured in minutes/hours on day of surgery for each patient.
Comparison of PACU time between the two groups
Time frame: PACU time is defined as the time from arrival in PACU until ready for discharge from PACU.
To compare rates of vomiting and self-reported nausea in PACU between the two groups
Time frame: Assessed from the time at which the patient is admitted to PACU until the time that they are discharged.
To compare the incidence of sore throat and hoarse voice between the two groups
Time frame: Collected on the day of surgery, 2-4 hours post discharge from PACU.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct removal of endotracheal tube and Laryngeal mask airway inserted following deep extubation in people with Endotracheal Extubation and Airway Anesthesia, run by Telethon Kids Institute at 8 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Australia, Brazil, Italy, Sweden and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Britta S. von Ungern-Sternberg, MD PHD (+618 6456 4806, britta.regli-vonungern@health.wa.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.