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Trial registered on ANZCTR
Registration number
ACTRN12624000666527p
Ethics application status
Submitted, not yet approved
Date submitted
5/04/2024
Date registered
24/05/2024
Date last updated
24/05/2024
Date data sharing statement initially provided
24/05/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
In children undergoing tonsillectomy surgery under general anaesthesia, are there identifiable differences in gut and oral microbiome profiles amongst those who develop emergence delirium in the recovery room and those who do not?
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Scientific title
Preoperative micrObiOme analysis in children and association with Postoperative Emergence Delirium (POOPED): a pilot cohort study
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Secondary ID [1]
311890
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
POOPED
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Emergence delirium
333469
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Paediatric tonsillectomy
333556
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Gastrointestinal microbiome
333557
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Condition category
Condition code
Anaesthesiology
330147
330147
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0
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Anaesthetics
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Surgery
330242
330242
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0
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Other surgery
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Tonsillectomy under general anaesthesia in children aged 2-7 years
Participants will have stool and oral swab samples collected one week preoperatively to provide specimens for microbiome analysis
Anaesthesia will be standardised and provided by a single anaesthetist for all subjects
Surgery will be standardised and performed or supervised by a single surgeon for all subjects
Participants will be observed in the recovery room to determine whether emergence delirium is present or not; recovery room stay is anticipated to be under 4 hours in most subjects
After exiting the recovery room, no further observation of subjects will be undertaken; all remaining data will be from the clinical record or already collected samples
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Intervention code [1]
328357
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Emergence delirium
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Assessment method [1]
337900
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Paediatric Anesthesia Emergence Delirium (PAED) score
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Timepoint [1]
337900
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5 and 20 minutes after eye-opening in post-anaesthesia care unit
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Secondary outcome [1]
433624
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Pain scores in the post-anaesthesia care unit
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Assessment method [1]
433624
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Verbal numerical rating scale
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Timepoint [1]
433624
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Post-anesthesia care unit only (immediately postoperative)
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Secondary outcome [2]
433996
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Length of hospital stay
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Assessment method [2]
433996
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Consultation with medical records
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Timepoint [2]
433996
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After discharge when scanned medical records are available
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Secondary outcome [3]
433997
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Microbiome profiles
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Assessment method [3]
433997
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Microbiome analysis
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Timepoint [3]
433997
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Preoperative specimen collection
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Secondary outcome [4]
433998
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Opioid consumption in post-anaesthesia care unit
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Assessment method [4]
433998
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Post-anaesthesia care unit only (immediately postoperative)
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Timepoint [4]
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In post-anaesthesia care unit; from medical records when these are scanned to the electronic record post-operatively
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Eligibility
Key inclusion criteria
Children aged 2-7 years undergoing elective tonsillectomy
Parent(s) able to read and speak English
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Minimum age
2
Years
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Maximum age
7
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Children receiving antibiotics within 12 weeks
Major medical comorbidity (ASA 3 or greater)
Recent gastrointestinal infection
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Stool and oral amplicon data will be quality controlled with dada2 embedded in QIIME2 and host contamination removed using Bowtie 2 (version 2.4.2). Taxonomy annotation of the data will be performed using QIIME2 feature classifier plugin with the Silva 138 database. R (version 4.2.2) packages of QIIM2R and phyloseq will be employed for diversity analyses. The Mann-Whitney-Wilcoxon test applied in the comparison of alpha diversity means between groups.
Adonis (R function for Permutational Multivariate Analysis) will be used to permute the distance matrix 999 times to yield p-values and explained sum of squares (ESS). This assesses statistical significance of metadata variables between two distance matrices in beta diversity analysis. Adonis Principal coordinate analysis (PCoA) plot with Bray-Curtis and Jaccard distances will be employed to reveal composition similarity between samples. Linear discriminant effect sizes (LEfSe) will be used to identify ED signatures. Further statistical tests comparing means and proportions of phenotype with clinical variables will be done in IBM SPSS.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/02/2025
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Actual
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Date of last participant enrolment
Anticipated
30/09/2025
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Actual
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Date of last data collection
Anticipated
28/11/2025
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
26374
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Albury Wodonga Health - Albury campus - Albury
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Recruitment postcode(s) [1]
42346
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2640 - Albury
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Funding & Sponsors
Funding source category [1]
316239
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Self funded/Unfunded
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Name [1]
316239
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Address [1]
316239
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Country [1]
316239
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Primary sponsor type
Hospital
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Name
Albury Wodonga Health
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Address
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Country
Australia
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Secondary sponsor category [1]
318425
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None
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Name [1]
318425
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Address [1]
318425
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Country [1]
318425
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
315060
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Albury Wodonga Health Human Research Ethics Committee
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Ethics committee address [1]
315060
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https://www.awh.org.au/for-health-professionals/research/research-and-ethics
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Ethics committee country [1]
315060
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Australia
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Date submitted for ethics approval [1]
315060
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23/05/2024
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Approval date [1]
315060
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Ethics approval number [1]
315060
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Summary
Brief summary
Children commonly display restless and irritable behaviours (known as emergence delirium (ED)) when awakening from general anaesthesia. Usually this is a short-lived and self-limiting problem however it can cause harm if wounds are disrupted, or intravenous lines are dislodged. Additionally, it can be distressing for parents and carers. Ways of reducing the risk of ED have been investigated but none has been shown to reliably prevent it from occurring. Some risk factors are known (for example, younger age, male sex, particular types of anaesthesia and surgery). The microbiome offers a potential insight into various psychological and behavioural conditions, and we wonder whether this might also be the case for ED. If particular microbiome profiles can be associated with different risk profiles and identified in advance of exposure to general anaesthesia, then perioperative management may be altered to reduce the risk of ED.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Luke Baitch
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Address
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Albury Wodonga Health, PO Box 326, Albury NSW 2640
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Country
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Australia
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Phone
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+61 260458575
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Fax
133542
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Email
133542
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[email protected]
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Contact person for public queries
Name
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Luke Baitch
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Address
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Albury Wdonga Health, PO Box 326, Albury NSW 2640
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Country
133543
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Australia
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Phone
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+61 260458575
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Fax
133543
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Email
133543
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[email protected]
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Contact person for scientific queries
Name
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Luke Baitch
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Address
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Albury Wodonga Health, PO Box 326, Albury NSW 2640
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Country
133544
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Australia
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Phone
133544
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+61 260458575
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Fax
133544
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Email
133544
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Deidentified microbiome data
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When will data be available (start and end dates)?
From end of study, for 10 years
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Available to whom?
This research team, for future projects
Other researchers, upon reasonable request
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Available for what types of analyses?
Other studies requiring microbiome data
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How or where can data be obtained?
Contacting principal investigator
[email protected]
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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.
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