Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000045819
Ethics application status
Approved
Date submitted
16/12/2011
Date registered
10/01/2012
Date last updated
12/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of performance of cuffed and uncuffed endotracheal tubes in a paediatric population: A randomised controlled trial.
Scientific title
Evaluation of performance of cuffed and uncuffed endotracheal tubes in a paediatric population: A randomised controlled trial.
Secondary ID [1] 279622 0
Princess Margaret Hospital for Children Ethics Committee and the Research Governance Office.
Registration number 1932/EP
Universal Trial Number (UTN)
Trial acronym
Cuffed versus Uncuffed ETT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
We hypothesize that there will be a higher rate of endotracheal tube leak in uncuffed compared with cuffed tubes, and that the rate of sore throat will be higher in the uncuffed group. 285416 0
We hypothesise that the rate of respiratory complications will be similar between the groups receiving either cuffed or uncuffed endotracheal tubes. 285420 0
We furthermore hypothesise that the loss in lung volume following a standardized recruitment maneouver will be greater in the children intubated with uncuffed ETTs as compared with cuffed ETTs. 285421 0
Condition category
Condition code
Anaesthesiology 285598 285598 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparing the use of Cuffed endotracheal tubes (ETT) to Uncuffed endotracheal tubes in the paediatric population.
The tubes will be used during elective surgery requiring invasive airway management. The duration of use will depend on the duration of the procedure in general between 30 and 120 min.
Intervention code [1] 283903 0
Treatment: Devices
Comparator / control treatment
The patients will be randomised to receive either a cuffed or an uncuffed ETT.
The differences between the tubes will be assessed using standardised volume ventilation to identify the leak between the different ETT devices and age groups.

Treatment: Volume ventilation - Tidal volume of 6ml/kg

Baseline tidal volumes & lung compliance prior to and after standardised recruitment manouvers.

Recruitment manoure 10 slow breaths up to 35 cmH2O with a PEEP of 5 cmH2O then Pressure Support Ventilation Peak pressure 10 on PEEP of 5

Incidence of respiratory adverse events (bronchospasm, laryngospasm, coughing, desaturations < 95%, airway obstruction & stridor in both groups.

Documenting incidence of above on CRF

Incidence of sore throat & airway trauma in both groups.
Documentation of blood staining on airway device post removal & completion of validated pain questionnaire by parent /child prior to discharge.
Control group
Active

Outcomes
Primary outcome [1] 286163 0
There will be a higher rate of endotracheal tube leak in uncuffed compared with cuffed tubes.
This will be assessed by calculating the difference between inspiratory and exspiratory tidal volumes.
Timepoint [1] 286163 0
Intraoperativley
Secondary outcome [1] 295283 0
The rate of sore throat will be higher in the uncuffed group.
This will be assessed postoperatively using a VAS scale 0-10.
Timepoint [1] 295283 0
Prior to dischcarge from ward to home

Eligibility
Key inclusion criteria
104 Children, aged 0 to 16 years, male or female, > 5 kg, undergoing elective surgery not showing any contraindications for the use of a cuffed or uncuffed ETT device (as assessed by an anaesthetist independent of the study team).
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Airway malformations (including Tonsillectomy & Adenotonsillectomy)
Contraindication for use of a cuffed or uncuffed ETT airway device as assessed by an anaesthetist independent of the study team
Likely postoperative ventilation on ICU.
Throat packs required

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The patients will be randomised by computer generated block randomization.

The randomization will be divided into 2 groups: School (> 6 years) and preschool children (< 6 years) with half the children recruited into each group.

Following written informed consent, the participant will be assigned the next available Participant Number in the randomised group. The Participant Number will correspond to a numbered randomisation envelope. The randomisation will be 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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The patients will be randomised by computer generated block randomization.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/01/2012
Actual
22/12/2011
Date of last participant enrolment
Anticipated
Actual
30/01/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
104
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 5019 0
Princess Margaret Hospital - Subiaco

Funding & Sponsors
Funding source category [1] 284397 0
Hospital
Name [1] 284397 0
Britta von Ungern-Sternberg
Country [1] 284397 0
Australia
Funding source category [2] 284401 0
University
Name [2] 284401 0
The University of Western Australia
Country [2] 284401 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospital for Children
Address
Roberts Road
Subiaco, WA 6008
Country
Australia
Secondary sponsor category [1] 283326 0
None
Name [1] 283326 0
Address [1] 283326 0
Country [1] 283326 0
Other collaborator category [1] 260402 0
Individual
Name [1] 260402 0
Anaesthetic Consultant Martin Lethbridge
Address [1] 260402 0
C/O Princess Margaret Children's Hospital
Department of Anaesthesia & Pain Mangement
Roberts Road
Subiaco
WA 6008
Country [1] 260402 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286356 0
Princess Margaret children's Hospital Ethics Committee
Ethics committee address [1] 286356 0
Princess Margaret Children's Hospital
Ethics Committee and Research Governance Office
GPO Box D184
Perth WA 6840
Ethics committee country [1] 286356 0
Australia
Date submitted for ethics approval [1] 286356 0
Approval date [1] 286356 0
20/10/2011
Ethics approval number [1] 286356 0
1932/EP

Summary
Brief summary
Having an operation is very safe for most patients and we wish to do research to improve patient care. To ensure the safe delivery of oxygen and anaesthesia gases to the child, the anaesthetist will insert a tube into the child’s mouth. Then the child’s lungs can be inflated and deflated by these gases. There are two tubes which can be used for this purpose. Both look very similar, except one has an inflatable balloon on the end. Both devices do the same thing and have been independently shown to be safe for use in children. However, a direct comparison between the two tubes is lacking in the paediatric population on how easily the lungs can be inflated. Therefore, the first aim of this study is to show if there are differences in inflating the child’s lungs. The second aim is to show there are no differences in the potential injury to the child’s throat from either tube type.
Trial website
Trial related presentations / publications
Nil yet.
Public notes

Contacts
Principal investigator
Name 33545 0
Prof Britta Regli-von Ungern-Sternberg
Address 33545 0
Princess Margaret Children's Hospital
Anaesthetic & Pain Management Department
Roberts Road
Subiaco
WA 6008
Country 33545 0
Australia
Phone 33545 0
+61893408109
Fax 33545 0
Email 33545 0
[email protected]
Contact person for public queries
Name 16792 0
Prof Britta Regli-von Ungern-Sternberg
Address 16792 0
C/O Princess Margaret Children's Hospital
Anaesthetic & Pain Management Department
Roberts Road
subiaco
WA 6008
Country 16792 0
Australia
Phone 16792 0
+61 8 93408109
Fax 16792 0
Email 16792 0
[email protected]
Contact person for scientific queries
Name 7720 0
Prof Britta Regli-von Ungern-Sternberg
Address 7720 0
C/O Princess Margaret Children's Hospital
Anaesthetic & Pain Management Department
Roberts Road
subiaco
WA 6008
Country 7720 0
Australia
Phone 7720 0
+61 8 93408109
Fax 7720 0
Email 7720 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

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