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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?
Scientific title
Preoperative micrObiOme analysis in children and association with Postoperative Emergence Delirium (POOPED): a pilot cohort study
Secondary ID [1] 311890 0
Nil known
Universal Trial Number (UTN)
Trial acronym
POOPED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emergence delirium 333469 0
Paediatric tonsillectomy 333556 0
Gastrointestinal microbiome 333557 0
Condition category
Condition code
Anaesthesiology 330147 330147 0 0
Anaesthetics
Surgery 330242 330242 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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
Intervention code [1] 328357 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337900 0
Emergence delirium
Timepoint [1] 337900 0
5 and 20 minutes after eye-opening in post-anaesthesia care unit
Secondary outcome [1] 433624 0
Pain scores in the post-anaesthesia care unit
Timepoint [1] 433624 0
Post-anesthesia care unit only (immediately postoperative)
Secondary outcome [2] 433996 0
Length of hospital stay
Timepoint [2] 433996 0
After discharge when scanned medical records are available
Secondary outcome [3] 433997 0
Microbiome profiles
Timepoint [3] 433997 0
Preoperative specimen collection
Secondary outcome [4] 433998 0
Opioid consumption in post-anaesthesia care unit
Timepoint [4] 433998 0
In post-anaesthesia care unit; from medical records when these are scanned to the electronic record post-operatively

Eligibility
Key inclusion criteria
Children aged 2-7 years undergoing elective tonsillectomy
Parent(s) able to read and speak English
Minimum age
2 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children receiving antibiotics within 12 weeks
Major medical comorbidity (ASA 3 or greater)
Recent gastrointestinal infection

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
30/09/2025
Actual
Date of last data collection
Anticipated
28/11/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26374 0
Albury Wodonga Health - Albury campus - Albury
Recruitment postcode(s) [1] 42346 0
2640 - Albury

Funding & Sponsors
Funding source category [1] 316239 0
Self funded/Unfunded
Name [1] 316239 0
Country [1] 316239 0
Primary sponsor type
Hospital
Name
Albury Wodonga Health
Address
Country
Australia
Secondary sponsor category [1] 318425 0
None
Name [1] 318425 0
Address [1] 318425 0
Country [1] 318425 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315060 0
Albury Wodonga Health Human Research Ethics Committee
Ethics committee address [1] 315060 0
https://www.awh.org.au/for-health-professionals/research/research-and-ethics
Ethics committee country [1] 315060 0
Australia
Date submitted for ethics approval [1] 315060 0
23/05/2024
Approval date [1] 315060 0
Ethics approval number [1] 315060 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133542 0
Dr Luke Baitch
Address 133542 0
Albury Wodonga Health, PO Box 326, Albury NSW 2640
Country 133542 0
Australia
Phone 133542 0
+61 260458575
Fax 133542 0
Email 133542 0
luke.baitch@awh.org.au
Contact person for public queries
Name 133543 0
Luke Baitch
Address 133543 0
Albury Wdonga Health, PO Box 326, Albury NSW 2640
Country 133543 0
Australia
Phone 133543 0
+61 260458575
Fax 133543 0
Email 133543 0
luke.baitch@awh.org.au
Contact person for scientific queries
Name 133544 0
Luke Baitch
Address 133544 0
Albury Wodonga Health, PO Box 326, Albury NSW 2640
Country 133544 0
Australia
Phone 133544 0
+61 260458575
Fax 133544 0
Email 133544 0
luke.baitch@awh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified microbiome data
When will data be available (start and end dates)?
From end of study, for 10 years
Available to whom?
This research team, for future projects
Other researchers, upon reasonable request
Available for what types of analyses?
Other studies requiring microbiome data
How or where can data be obtained?
Contacting principal investigator luke.baitch@awh.org.au


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.