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Trial registered on ANZCTR


Registration number
ACTRN12610000250033
Ethics application status
Approved
Date submitted
12/03/2010
Date registered
24/03/2010
Date last updated
24/09/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial: Respiratory complications in infants undergoing general anaesthesia with a laryngeal mask airway versus an endotracheal tube
Scientific title
Randomised controlled trial: Respiratory complications in infants undergoing general anaesthesia with a laryngeal mask airway versus an endotracheal tube
Secondary ID [1] 1512 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory complications in children receiving either a laryngeal mask airway or an endotracheal tube 256965 0
Condition category
Condition code
Anaesthesiology 257108 257108 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Endotracheal intubation for airway maintenance for elective surgical procedure following induction of anaesthesia.
The procedure is a one off intervention with the endotracheal tube staying in place for the total duration of the procedure which ranges from approx. 30 min to 2 hours.
Intervention code [1] 256142 0
Treatment: Devices
Intervention code [2] 256167 0
Prevention
Comparator / control treatment
Laryngeal mask airway for airway maintenance for elective surgical procedure
following induction of anaesthesia.
The procedure is a one off intervention with the laryngeal mask airway staying in place for the total duration of the procedure which ranges from approx. 30 min to 2 hours.
Control group
Active

Outcomes
Primary outcome [1] 258003 0
total of respiratory complications.
Presence of perioperative respiratory complication as defined by one or more of the following:
Bronchospasm, laryngospasm, severe coughing, desaturation < 95%, airway obstruction and/or stridor.
The presence/absence of respiratory complications will be recorded during the time of anaesthesia and the time spent in recovery. The overall presence of respiratory complications will be taken for the analysis
Timepoint [1] 258003 0
during the time of anaesthesia and the time spent in recovery.
Secondary outcome [1] 263557 0
occurrence and frequency of the individual respiratory complications in both intra-operatively and in the recovery area.
THe outcome will be assessed by clinical monitoring.
Timepoint [1] 263557 0
during the time of anaesthesia and the time spent in recovery.

Eligibility
Key inclusion criteria
Children, aged 0 to 12 months, male or female undergoing combined general and regional (e.g. caudal, penile block) anaesthesia with the plan to use either a laryngeal mask airway or endotracheal tube (as assessed by an anaesthetist independent of the study team).
Minimum age
No limit
Maximum age
12 Months
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 of laryngeal mask airway or endotracheal tube use as assessed by an anaesthetist independent of the study team.

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)
All patients will be recruited at the pre-anaesthetic visit. Only patients who meet the inclusion criteria for the study will be enrolled and only after informed consent is given voluntarily by the parent/guardian. The patients will be randomised by computer generated block randomisation. The participant will be assigned the next available Participant Number
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/05/2010
Actual
8/07/2010
Date of last participant enrolment
Anticipated
20/04/2016
Actual
7/05/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
290
Accrual to date
Final
181
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 256645 0
Hospital
Name [1] 256645 0
Princess Margaret Hospital for Children
Country [1] 256645 0
Australia
Funding source category [2] 288367 0
Charities/Societies/Foundations
Name [2] 288367 0
Princess Margaret Hospital Foundation
Country [2] 288367 0
Australia
Primary sponsor type
Individual
Name
Britta Regli-von Ungern-Sternberg
Address
Princess Margaret Hospital for Children
Department of Anaesthesia
Roberts Road
SUBIACO,
WA 6008
Country
Australia
Secondary sponsor category [1] 255932 0
Individual
Name [1] 255932 0
Neil Chambers
Address [1] 255932 0
Princess Margaret Hospital for Children
Department of Anaesthesia
Roberts Road
SUBIACO,
WA 6008
Country [1] 255932 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258669 0
Princess Margaret Hospital for Children Ethics Committee
Ethics committee address [1] 258669 0
Princess Margaret Hospital for Children Ethics Committee
Roberts Road
Subiaco
WA 6008
Australia
Ethics committee country [1] 258669 0
Australia
Date submitted for ethics approval [1] 258669 0
11/03/2010
Approval date [1] 258669 0
20/05/2010
Ethics approval number [1] 258669 0
1786/EP

Summary
Brief summary
Infants undergoing minor elective surgery have their airway managed at the discretion of the anaesthetist in charge with either an endotracheal tube or an laryngeal mask airway. Research already done witin the Princess Margaret Hospital for Children (PMH) Anaesthetic Unit has identified some patients with asthma, eczema, hay fever, a current cold & exposure to smoking have a higher risk of airway complications following their surgery. However, the best practice for the management of an infant's airway is still under debate.
The aim of this study is to identify which airway support, laryngeal mask or endotracheal tube, is safer in regards to respiratory problems in the perioperative period for infants (0-12 months) undergoing minor general surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30931 0
Prof Britta Regli-von Ungern-Sternberg
Address 30931 0
Princess Margaret Hospital for Children
Department of Anaesthesia
Roberts Road
SUBIACO,
WA 6008
Country 30931 0
Australia
Phone 30931 0
+61893408109
Fax 30931 0
Email 30931 0
[email protected]
Contact person for public queries
Name 14178 0
Britta Regli-von Ungern-Sternberg
Address 14178 0
Department of Anaesthesia
Roberts Road
SUBIACO, WA 6008
Country 14178 0
Australia
Phone 14178 0
+61893408109
Fax 14178 0
Email 14178 0
[email protected]
Contact person for scientific queries
Name 5106 0
Britta Regli-von Ungern-Sternberg
Address 5106 0
Department of Anaesthesia
Roberts Road
SUBIACO, WA 6008
Country 5106 0
Australia
Phone 5106 0
+61893408109
Fax 5106 0
Email 5106 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
EmbaseThe effect of endotracheal tubes versus laryngeal mask airways on perioperative respiratory adverse events in infants: a randomised controlled trial.2017https://dx.doi.org/10.1016/S0140-6736%2816%2931719-6
N.B. These documents automatically identified may not have been verified by the study sponsor.