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Trial registered on ANZCTR
Registration number
ACTRN12609000387224
Ethics application status
Approved
Date submitted
12/05/2009
Date registered
29/05/2009
Date last updated
12/01/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
Timing of laryngeal mask removal in children with a high risk for postoperative respiratory complications –awake or anesthetized?
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Scientific title
A randomised controlled trial to assess respiratory complications following removal of a laryngeal mask (awake vs. anaesthetised) in children undergoing adeno-/tonsillectomy with a high risk of postoperative respiratory complications
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Secondary ID [1]
283699
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
respiratory complications in paediatric anaesthesia
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Condition category
Condition code
Anaesthesiology
237103
237103
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0
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Anaesthetics
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Group “awake”
The children of group “awake” will have their laryngeal mask airway (LMA) removed awake. The LMA will be removed when the children have demonstrated facial grimace, adequate tidal volume and respiratory rate, coughing with open mouths or opening of their eyes and purposeful movements.
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Intervention code [1]
4542
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Other interventions
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Comparator / control treatment
Group “anesthetised”
The children of the group “anaesthetised” will have their LMA removed during the surgical stage of general anaesthesia when the end-tidal sevoflurane level is greater than 1 minimum alveolar concentration (MAC). Sevoflurane is administered via an anaesthetic vaporiser. At induction of anaesthesia it is slowly increased to a dose of greater than one MAC and then left constant throughout surgery.
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Control group
Active
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Outcomes
Primary outcome [1]
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Primary endpoint will be the total of respiratory complications in the perioperative period.
Presence of perioperative respiratory complication as defined one or more of the following:
Bronchospasm, laryngospasm, severe coughing, desaturation < 95%, airway obstruction and/or stridor.
Laryngospasm is defined as a complete airway obstruction associated with muscle rigidity of the abdominal and chest walls. Bronchospasm is defined as the occurrence of an increased respiratory effort, especially during expiration, and wheeze on auscultation. Airway obstruction is defined as the presence of partial airway obstruction in combination with a snoring noise and respiratory efforts. Assessement via clinical examination and observation.
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Assessment method [1]
5933
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Timepoint [1]
5933
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Respiratory complications will be monitored continuously in the perioperative period
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Secondary outcome [1]
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presence of individual respiratory complication (laryngospasm, bronchospasm, desaturation, severe coughing, airway obstruction stridor) Details see above under primary outcome Assessement via clinical examination and observation.
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Assessment method [1]
242028
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Timepoint [1]
242028
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Respiratory complications will be monitored continuously in the perioperative period
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Eligibility
Key inclusion criteria
Children, aged 0 to 16 years, male or female undergoing elective adenoidectomy or adenotonsillectomies with or without grommets insertion with one or more of the following risk factors (I-III) with the plan to use a laryngeal mask airway (as assessed by an anaesthetist independent of the study team):
I. Airway susceptibility as defined as 1 or more of the following
a. Cold or flu in the last two weeks
b. Wheezing > 3 times in the last 12 months
c. Wheezing at exercise
d. Nocturnal dry cough
II. Current or past eczema
III. Positive family history as defined as 1 or more of the following
a. =2 family members with asthma
b. =2 family members with eczema
c. =2 family members with hayfever
d. Only mother smoking or mother and father smoking
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Minimum age
No limit
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Maximum age
16
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Known cardiac disease, airway or thoracic malformations, need for premedication with midazolam.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Inclusion and exclusion criteria will be checked at the preanaesthetic assessment. Written consent consisting of parental permission and also child assent when applicable, will be obtained. The person determining if a child is eligible for inclusion in the trial is unaware when the decision is made to which group the child would be allocated. Following inclusion into the study protocol, the children will be randomly assigned to group “awake” or group “anesthetised” by computer generated block randomisation. Allocation will be concealed in sealed opaque envelopes.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The patients will be randomised by computer generated block randomisation. Following written informed consent, the participant will be assigned the next available Participant Number. The Participant Number will correspond to a numbered randomisation envelope. The randomisation is concealed in the closed envelope and will only be opened by the anaesthetist in charge of the patient at induction of anaesthesia. The participant number will be used to identify the patient for the duration of the study.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
15/06/2009
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Actual
6/07/2009
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Date of last participant enrolment
Anticipated
31/03/2014
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Actual
28/01/2014
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
290
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Accrual to date
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Final
290
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Princess Margaret Hospital - Subiaco
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Funding & Sponsors
Funding source category [1]
4950
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Hospital
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Name [1]
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Princess Margaret Hospital for Children Department of Anaesthesia
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Address [1]
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Princess Margaret Hospital for Children Roberts Road SUBIACO, WA 6008
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Country [1]
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Australia
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Funding source category [2]
288382
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Charities/Societies/Foundations
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Name [2]
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Princess Margaret Hospital Foundation
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Address [2]
288382
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68 Hay street
Subiaco
WA 6008
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Country [2]
288382
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Australia
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Funding source category [3]
288383
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Government body
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Name [3]
288383
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NHMRC
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Address [3]
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National Health and Medical Research Council
GPO Box 1421
Canberra
ACT 2601
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Country [3]
288383
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Australia
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Primary sponsor type
Individual
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Name
Britta von Ungern-Sternberg
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Address
Department of Anaesthesia
Princess Margaret Hospital for Children Roberts Road SUBIACO, WA 6008
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Mairead Heaney
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Address [1]
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Department of Anaesthesia
Princess Margaret Hospital for Children Roberts Road SUBIACO, WA 6008
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Country [1]
4469
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
239162
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Ethics Committee Princess Margaret Hospital
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Ethics committee address [1]
239162
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Roberts Road
Subiaco, WA 6008
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Ethics committee country [1]
239162
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Australia
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Date submitted for ethics approval [1]
239162
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Approval date [1]
239162
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25/05/2009
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Ethics approval number [1]
239162
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1645/EP
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Summary
Brief summary
Removal of the laryngeal mask airway can be performed while children are still deeply anesthetized or when they are awake (as defined by eye opening, grimacing, coughing, and purposeful movements). Each technique has its own advantages and disadvantages. In healthy children, it has been shown that there are no clinical differences between removal of the laryngeal mask airway in the awake state vs anesthetized state. In patients with a high risk of developing a postoperative respiratory problems (e.g. coughing) such as those with asthma, it may be preferable to remove the laryngeal mask airway while the patients are still anesthetized to avoid airway stimulation and consecutively bucking, coughing and bronchospasm. The results of a recent large prospective cohort study at our institution with over 9000 children allow to identify children with a high risk for developping postoperative respiratory complications.
The aim of this present randomized controlled trial is to assess whether children at a high risk for respiratory problems benefit from anethetized removal of the laryngeal mask airway as compared to awake removal of the laryngeal mask airway following adenoidectomy. We hypothesize that children with a high risk for respiratory problems defined by the presence of either airway susceptibility, eczema or a positive family history who have their laryngeal mask airway removed deeply anaesthetised will demonstrate less respiratory problems compared with high risk children who have it removed awake.
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Trial website
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Trial related presentations / publications
None yet.
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Public notes
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Contacts
Principal investigator
Name
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Prof Britta Regli-von Ungern-Sternberg
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Address
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Department of Anaesthesia and pain management
Princess Margaret Hospital for Children
Roberts Road
Subiaco
WA 6008
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Country
29597
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Australia
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Phone
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+61893408109
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Fax
29597
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Email
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[email protected]
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Contact person for public queries
Name
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Prof Britta von Ungern-Sternberg
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Address
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Princess Margaret Hospital for Children
Department of Anaesthesia
Roberts Road
Subiaco, WA 6008
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Country
12844
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Australia
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Phone
12844
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+61893408109
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Fax
12844
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Email
12844
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[email protected]
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Contact person for scientific queries
Name
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Prof Britta von Ungern-Sternberg
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Address
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Princess Margaret Hospital for Children
Department of Anaesthesia
Roberts Road
Subiaco, WA 6008
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Country
3772
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Australia
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Phone
3772
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+61893408109
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Fax
3772
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Email
3772
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Deep or awake removal of laryngeal mask airway in children at risk of respiratory adverse events undergoing tonsillectomy-a randomised controlled trial.
2018
https://dx.doi.org/10.1016/j.bja.2017.11.094
N.B. These documents automatically identified may not have been verified by the study sponsor.
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