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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?
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
Secondary ID [1] 283699 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
respiratory complications in paediatric anaesthesia 4763 0
Condition category
Condition code
Anaesthesiology 237103 237103 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 4542 0
Other interventions
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.
Control group
Active

Outcomes
Primary outcome [1] 5933 0
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.
Timepoint [1] 5933 0
Respiratory complications will be monitored continuously in the perioperative period
Secondary outcome [1] 242028 0
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.
Timepoint [1] 242028 0
Respiratory complications will be monitored continuously in the perioperative period

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
Minimum age
No limit
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known cardiac disease, airway or thoracic malformations, need for premedication with midazolam.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2009
Actual
6/07/2009
Date of last participant enrolment
Anticipated
31/03/2014
Actual
28/01/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
290
Accrual to date
Final
290
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 5021 0
Princess Margaret Hospital - Subiaco

Funding & Sponsors
Funding source category [1] 4950 0
Hospital
Name [1] 4950 0
Princess Margaret Hospital for Children Department of Anaesthesia
Country [1] 4950 0
Australia
Funding source category [2] 288382 0
Charities/Societies/Foundations
Name [2] 288382 0
Princess Margaret Hospital Foundation
Country [2] 288382 0
Australia
Funding source category [3] 288383 0
Government body
Name [3] 288383 0
NHMRC
Country [3] 288383 0
Australia
Primary sponsor type
Individual
Name
Britta von Ungern-Sternberg
Address
Department of Anaesthesia
Princess Margaret Hospital for Children Roberts Road SUBIACO, WA 6008
Country
Australia
Secondary sponsor category [1] 4469 0
Individual
Name [1] 4469 0
Mairead Heaney
Address [1] 4469 0
Department of Anaesthesia
Princess Margaret Hospital for Children Roberts Road SUBIACO, WA 6008
Country [1] 4469 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239162 0
Ethics Committee Princess Margaret Hospital
Ethics committee address [1] 239162 0
Ethics committee country [1] 239162 0
Australia
Date submitted for ethics approval [1] 239162 0
Approval date [1] 239162 0
25/05/2009
Ethics approval number [1] 239162 0
1645/EP

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29597 0
Prof Britta Regli-von Ungern-Sternberg
Address 29597 0
Department of Anaesthesia and pain management
Princess Margaret Hospital for Children
Roberts Road
Subiaco
WA 6008
Country 29597 0
Australia
Phone 29597 0
+61893408109
Fax 29597 0
Email 29597 0
[email protected]
Contact person for public queries
Name 12844 0
Britta von Ungern-Sternberg
Address 12844 0
Princess Margaret Hospital for Children
Department of Anaesthesia
Roberts Road
Subiaco, WA 6008
Country 12844 0
Australia
Phone 12844 0
+61893408109
Fax 12844 0
Email 12844 0
[email protected]
Contact person for scientific queries
Name 3772 0
Britta von Ungern-Sternberg
Address 3772 0
Princess Margaret Hospital for Children
Department of Anaesthesia
Roberts Road
Subiaco, WA 6008
Country 3772 0
Australia
Phone 3772 0
+61893408109
Fax 3772 0
Email 3772 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseDeep or awake removal of laryngeal mask airway in children at risk of respiratory adverse events undergoing tonsillectomy-a randomised controlled trial.2018https://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.