Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000291280
Ethics application status
Approved
Date submitted
5/03/2009
Date registered
18/05/2009
Date last updated
21/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Extubation in children with a high risk for postoperative respiratory complications –awake or anesthetized?
Scientific title
A randomised controlled trial to assess respiratory complications following extubation (awake vs. anaesthetised) in children undergoing tonsillectomy with a high risk of postoperative respiratory complications
Secondary ID [1] 283948 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 4425 0
Condition category
Condition code
Anaesthesiology 4690 4690 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group “awake”
The children of group “awake” will be extubated awake following an anaesthetic with sevoflurane. The endotracheal tube 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] 4167 0
Other interventions
Comparator / control treatment
Group “anesthetised”
The children of the group “anaesthetised” will be extubated during the surgical stage of general anaesthesia when the end-tidal sevoflurane level is greater than 1 minimum alveolar concentration (MAC).
Control group
Active

Outcomes
Primary outcome [1] 5555 0
Primary outcomes 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] 5555 0
Respiratory complications will be monitored continuously in the perioperative period
Secondary outcome [1] 242049 0
Secondary outcomes will be the occurrence of the individual respiratory complication. 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] 242049 0
Respiratory complications will be monitored continuously in the perioperative period.

Eligibility
Key inclusion criteria
Children, aged 0 to 16 years, male or female with one or more of the following risk factors (I-III)
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. Mother 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, contraindication for deep extubation (e.g. gastrooesophageal reflux).

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/guardian 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
1/03/2009
Actual
21/01/2009
Date of last participant enrolment
Anticipated
Actual
18/05/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4614 0
Hospital
Name [1] 4614 0
Princess Margaret Hospital for Children
Department of Anaesthesia
Country [1] 4614 0
Australia
Funding source category [2] 288584 0
Charities/Societies/Foundations
Name [2] 288584 0
Princess Margaret Hospital Foundation
Country [2] 288584 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] 4161 0
Individual
Name [1] 4161 0
Mairead Heaney
Address [1] 4161 0
Department of Anaesthesia
Princess Margaret Hospital for Children
Roberts Road, Subiaco, WA 6008
Country [1] 4161 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290448 0
Princess Margaret Hospital for Children Ethics Committee
Ethics committee address [1] 290448 0
Ethics committee country [1] 290448 0
Australia
Date submitted for ethics approval [1] 290448 0
18/11/2008
Approval date [1] 290448 0
20/11/2008
Ethics approval number [1] 290448 0
1599/EP

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

Contacts
Principal investigator
Name 29356 0
Prof Britta Regli-von Ungern-Sternberg
Address 29356 0
Department of Anaesthesia and Pain management
Princess Margaret Hospital
Roberts Road
Subiaco
WA 6008
Country 29356 0
Australia
Phone 29356 0
+61893408109
Fax 29356 0
Email 29356 0
[email protected]
Contact person for public queries
Name 12603 0
Britta von Ungern-Sternberg
Address 12603 0
Princess Margaret Hospital for Children
Department of Anaesthesia
Roberts Road
Subiaco, WA 6008
Country 12603 0
Australia
Phone 12603 0
+61893408109
Fax 12603 0
Email 12603 0
[email protected]
Contact person for scientific queries
Name 3531 0
Britta von Ungern-Sternberg
Address 3531 0
Princess Margaret Hospital for Children
Department of Anaesthesia
Roberts Road
Subiaco WA 6008
Country 3531 0
Australia
Phone 3531 0
+61893408109
Fax 3531 0
Email 3531 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
No additional documents have been identified.