Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000362897
Ethics application status
Approved
Date submitted
25/02/2021
Date registered
31/03/2021
Date last updated
17/03/2022
Date data sharing statement initially provided
31/03/2021
Date results information initially provided
17/03/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised control trial comparing the timing of the removal of the laryngeal mask airway (LMA) after tonsillectomies in children and the likelihood of delirium occurring on emergence in the post anaesthesia care unit (PACU).
Scientific title
Deep versus awake removal of the laryngeal mask airway after tonsillectomy in children and its effect on emergence delirium in the PACU: a randomised controlled trial.
Secondary ID [1] 303550 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emergence Delirium 320902 0
Condition category
Condition code
Anaesthesiology 318718 318718 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be when to remove the child's LMA after the surgeon has performed the tonsillectomy. Upon consent from the parents for their child to participate in the study, the anaesthetist in charge will be notified by the student when to remove the LMA. This is a randomized procedure with two options: Deep (removing the LMA whilst the child is anaesthetised) or awake (removing the LMA in the PACU upon awakening). Deep removal of the LMA will occur within 2 minutes of completion of tonsillectomy in the operating theatre. The child will be placed in the left lateral position and LMA removed by the attending anaesthetist. In the awake group, the LMA will be removed by the nurse upon the child opening their eyes. Approximately within 20 minutes post tonsillectomy.

The student will take no part in the surgery or induction and maintenance of anaesthesia. Fidelity to the intervention will be monitored by the student who is observing and recording the study.
Intervention code [1] 319837 0
Treatment: Devices
Comparator / control treatment
The study hypothesizes that deep LMA removal in children undergoing tonsillectomy will lower the incidence of emergence delirium in the post-anaesthesia care unit compared to awake LMA removal. Hence our reference group for this study is the awake group.
Control group
Active

Outcomes
Primary outcome [1] 326658 0
Emergence delirium defined as greater than or equal to a score of 10 using the post anaesthesia emergence delirium (PAED) scale.
Timepoint [1] 326658 0
A PAED score will be gathered preoperatively and then 5 minutes and 20 minutes upon awakening postoperatively. Timing will be performed using a stopwatch.
Secondary outcome [1] 392302 0
Nil
Timepoint [1] 392302 0
Nil

Eligibility
Key inclusion criteria
Children aged 2-7 years undergoing elective tonsillectomy
Successful placement of LMA after induction of anaesthesia
Minimum age
2 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known or suspected difficult airway
Endotracheal intubation for tonsillectomy for any medical or anaesthetic indication
Anaesthetist concern regarding deep airway removal for any medical or anaesthetic reason
Parents unable to speak English

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sample randomisation created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
15/02/2021
Date of last participant enrolment
Anticipated
12/09/2021
Actual
29/09/2021
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
124
Accrual to date
Final
124
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18820 0
Albury Wodonga Health - Albury campus - Albury
Recruitment hospital [2] 18821 0
Albury-Wodonga Private Hospital - Albury
Recruitment postcode(s) [1] 33271 0
2640 - Albury

Funding & Sponsors
Funding source category [1] 307975 0
University
Name [1] 307975 0
University of New South Wales
Country [1] 307975 0
Australia
Primary sponsor type
Individual
Name
Dr Luke Baitch
Address
Albury Wodonga Health
Albury Base Hospital
201 Borella Rd, East Albury NSW 2640



559 East St, East Albury NSW 2640
Country
Australia
Secondary sponsor category [1] 308694 0
Individual
Name [1] 308694 0
Dhruv Kapoor
Address [1] 308694 0
Albury Rural Clinical School (branch of UNSW)
559 East St, East Albury NSW 2640
Country [1] 308694 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307966 0
Albury Wodonga Health Human Research Ethics Committee
Ethics committee address [1] 307966 0
Albury Hospital
Borella Road
Albury
NSW
2640
Ethics committee country [1] 307966 0
Australia
Date submitted for ethics approval [1] 307966 0
Approval date [1] 307966 0
05/11/2020
Ethics approval number [1] 307966 0

Summary
Brief summary
Emergence delirium is a very common occurrence, typically presenting in young children, after waking up from anaesthesia. Emergence delirium poses risks for the child as they are likely to harm themselves by removing intravenous drips, catheters etc It also poses significant stress on the nurses and can cause dissatisfaction among the parents in regards to the care their child is receiving. Tonsillectomies are common surgical procedures performed on children so trying to minimize emergence delirium will be beneficial for all involved.

Previous studies and research have shown the benefits of a laryngeal mask airway over an endotracheal tube but research is limited in terms of when the laryngeal mask airway should be removed. We hypothesize that the removal of the laryngeal mask airway whilst anaesthetized (deep) at the end of surgery for tonsillectomy in children aged 2-7 years results in a lower incidence of emergence delirium in the post-anaesthesia care unit compared to awake removal of the laryngeal mask airway.

Patients will be recruited after consent is gained by the student or the student's supervisor from the child's parents. The student will then observe the child before the surgery and then for 5 minutes and 20 minutes after the child awakens from surgery. If the child or parents feel uncomfortable with their child's participation during the study then they are able to sign a withdrawal form (attached to the consent form) at any time stating a reason for withdrawal.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109074 0
Mr Dhruv Kapoor
Address 109074 0
Albury Rural Clinical School (branch of UNSW)
559 East St, East Albury NSW 2640
Country 109074 0
Australia
Phone 109074 0
+61 470441242
Fax 109074 0
Email 109074 0
[email protected]
Contact person for public queries
Name 109075 0
Mr Dhruv Kapoor
Address 109075 0
Albury Rural Clinical School (branch of UNSW)
559 East St, East Albury NSW 2640
Country 109075 0
Australia
Phone 109075 0
+61 470441242
Fax 109075 0
Email 109075 0
[email protected]
Contact person for scientific queries
Name 109076 0
Dr Luke Baitch
Address 109076 0
Albury Wodonga Health
Albury Base Hospital
201 Borella Rd, East Albury NSW 2640
Country 109076 0
Australia
Phone 109076 0
+61 406586318
Fax 109076 0
Email 109076 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
My supervisor and I deemed it was not of interest to those involved.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10813Informed consent form    381504-(Uploaded-25-02-2021-17-23-07)-Study-related document.docx
10814Ethical approval    381504-(Uploaded-29-03-2021-10-34-43)-Study-related document.pdf



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.