Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000018516
Ethics application status
Approved
Date submitted
6/12/2023
Date registered
10/01/2024
Date last updated
27/10/2024
Date data sharing statement initially provided
10/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating whether environmental factors such as air quality, pollen and socio-economic indices play affect the risk of perioperative respiratory adverse events in children
Scientific title
Children’s Health and the Environment: Establishing metrics To Assess the level of anaesthetic Health risk in Children (CHEETAH)
Secondary ID [1] 311071 0
Nil
Universal Trial Number (UTN)
Trial acronym
CHEETAH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perioperative Respiratory Adverse Events 332215 0
Children undergoing general anaesthesia 332227 0
Condition category
Condition code
Anaesthesiology 328928 328928 0 0
Anaesthetics
Surgery 328929 328929 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
A single centre prospective observational cluster cohort study will be carried out at Perth Children’s Hospital in Western Australia.

All children undergoing surgery under general anaesthesia who arrive in the PCH post-anaesthetic care unit (PACU) between 0800 and 1800 on weekdays during the data collection periods will be included in this study using a waiver of consent. There is no active participation for participants, all data is collected through the course of routine clinical care by anaesthetists and post-anaesthetic care unit (PACU) nurses and recorded on a paper data sheet. Pre-operative data collection will be done by anaesthetists and will involve recording anaesthetist-assessed respiratory risk factors (recent upper respiratory tract infection, history of asthma symptoms and/or diagnosis, parent/caregiver currently smoking, history of prematurity less than 32 weeks' gestation) and symptoms of sleep disordered breathing (snoring, incidence of trouble breathing at night, witnessed apnoea's, history of waking unrefreshed in the morning). This is collected as part of clinical care consultations prior to anaesthesia. The treating anaesthetist will record details of their anaesthetic management, and the incidence of any respiratory adverse events during induction, maintenance, emergence or peri-extubation periods of anaesthesia. The treating PACU nurse will record any incidence of respiratory adverse events during the patient's stay in PACU.

Data collection will occur over four periods in 2024 to investigate the incidence of PRAE at timepoints that align with typical seasonal trends of air quality and pollen load. The first data collection period will occur over four weeks starting in February 2024, when PM2.5 and PM10 associated with wildfires and annual ozone concentrations are at their highest levels. The second data collection period will take place over 17 weeks between April and August, when air quality in Western Australia is most heavily impacted by prescribed/controlled burns, and the use of domestic wood heaters. The third data collection period will happen over 12 weeks beginning in August 2024, when the pollen counts are typically highest. The fourth data collection period will occur between October and December, when air quality is again adversely affected by ozone and prescribed burning activity.

Data collected over these four periods will be complemented by previously collected prospective data collected for the POSSUM study (RGS0000005292; ACTRN12622000559718) which recruited Perth Children's Hospital (PCH) patients undergoing general anaesthesia between 03rd October and 23rd December 2022. No recorded data on Perth pollen counts exists for POSSUM data collected in October 2022, due to required service and maintenance on the pollen counting machinery. Data will therefore be collected in October 2024 to capture a complete set of data for the duration of the Perth pollen season, which typically runs from August to November. POSSUM data includes complete data sets for all parameters to be assessed in CHEETAH: respiratory risk factors, anaesthetic management and incidence of respiratory adverse events.
Intervention code [1] 327520 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336729 0
Assess the incidence of perioperative respiratory adverse events (PRAE) in paediatric patients undergoing general anaesthesia. PRAE are defined as:
o Laryngospasm: complete airway obstruction with associated muscle rigidity of the abdominal and chest walls.
o Bronchospasm: increased respiratory effort, particularly during expiration and wheeze on auscultation.
o Desaturation: Oxygen saturation < 95% for >10secs on pulse oximetry
o Airway obstruction: the presence of airway obstruction with a snoring noise and/or increased respiratory efforts.
o Severe persistent coughing: pronounced, persistent coughs lasting more than 10 seconds.
o Post-operative stridor: high pitched sound during breathing in the postoperative period.
Timepoint [1] 336729 0
PRAE will be assessed at induction, maintenance, emergence, peri-extubation and recovery from anaesthesia.
Primary outcome [2] 336730 0
Determine the level of pollen exposure in paediatric patients undergoing general anaesthesia.
Timepoint [2] 336730 0
Pollen counts will be recorded hourly for the duration of each data collection period in order to compare times of the year with high pollen counts to times with lower pollen counts.
Primary outcome [3] 337055 0
Determine the exposure to air pollutants (PM2.5, PM10, ozone, sulfur dioxide, nitrogen dioxide, carbon monoxide) in paediatric patients undergoing general anaesthesia.
Timepoint [3] 337055 0
Measurements of air quality from each monitoring station will be recorded hourly for the duration of each data collection period.
Secondary outcome [1] 429527 0
Assess respiratory risk factors in children undergoing general anaesthesia.
Timepoint [1] 429527 0
Risk factors will be assessed prior to the induction of anaesthesia.
Secondary outcome [2] 430530 0
[Primary outcome 4] Assessment of residential socio-economic indexes for area (SEIFA) of paediatric patients undergoing general anaesthesia. The following four indexes and deciles will be used:
o Index of the relative socio-economic advantage and disadvantage (IRSAD)
o Index of relative socio-economic disadvantage (IRSD)
o Index of education and occupation (IEO)
o Index of economic resources (IER)
Timepoint [2] 430530 0
[Primary outcome 4] Each of the SEIFA indexes are calculated using the most recent available census data.

Eligibility
Key inclusion criteria
All children presenting for elective and emergency procedures under general anaesthesia in the operating theatres who will be post-operatively transferred to the post-anaesthetic care unit (PACU) between 8:00 and 18:00 on weekdays during the data collection periods.
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have been an inpatient for more than 24 hours prior to the induction of anaesthesia (theme one and two only)

Patients transferred from theatre straight to the paediatric or neonatal intensive care unit (PICU/NICU)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The three primary outcomes may be able to be analysed within a single model if the data allows this. Missing data patterns may make this unfeasible, in such a case individual models will be utilised. Since the incidence of PRAE is binary (Yes if child suffers any PRAE incidence and no otherwise), we will fit binary log-linear regression models to the data. A sample size of 7,000 gives a power of 0.95. Given that the data is likely to have high levels of variation, we would expect the power to be lower in practice. Nonetheless, a sample size of 7,000 is feasible when including patients recruited for previously approved POSSUM study, and we will adopt this. We expect to include 10,000 patients into this study in 2024 from Perth Children’s Hospital, in addition to the 2,850 included in the POSSUM study. This sample size is therefore sufficient for a highly powered study.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2024
Actual
1/02/2024
Date of last participant enrolment
Anticipated
20/12/2024
Actual
Date of last data collection
Anticipated
20/12/2024
Actual
Sample size
Target
10000
Accrual to date
7200
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 25899 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 41734 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 315328 0
Hospital
Name [1] 315328 0
Perth Children's Hospital
Country [1] 315328 0
Australia
Funding source category [2] 315341 0
Government body
Name [2] 315341 0
NHMRC
Country [2] 315341 0
Australia
Primary sponsor type
Hospital
Name
Child and Adolescent Health Executive, Perth Children's Hospital
Address
Perth Children's Hospital, 15 Hospital Avenue, Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 317401 0
None
Name [1] 317401 0
Address [1] 317401 0
Country [1] 317401 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314251 0
Child and Adolescent Health Services HREC
Ethics committee address [1] 314251 0
Ethics committee country [1] 314251 0
Australia
Date submitted for ethics approval [1] 314251 0
27/11/2023
Approval date [1] 314251 0
15/12/2023
Ethics approval number [1] 314251 0
RGS0000006572

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130934 0
Prof Britta von Ungern-Sternberg
Address 130934 0
Department of Anaesthesia & Pain Medicine, Perth Children's Hospital, 15 Hospital Avenue, Nedlands WA 6009
Country 130934 0
Australia
Phone 130934 0
+610420790101
Fax 130934 0
Email 130934 0
[email protected]
Contact person for public queries
Name 130935 0
Britta von Ungern-Sternberg
Address 130935 0
Department of Anaesthesia & Pain Medicine, Perth Children's Hospital, 15 Hospital Avenue, Nedlands WA 6009
Country 130935 0
Australia
Phone 130935 0
+610420790101
Fax 130935 0
Email 130935 0
[email protected]
Contact person for scientific queries
Name 130936 0
Britta von Ungern-Sternberg
Address 130936 0
Department of Anaesthesia & Pain Medicine, Perth Children's Hospital, 15 Hospital Avenue, Nedlands WA 6009
Country 130936 0
Australia
Phone 130936 0
+610420790101
Fax 130936 0
Email 130936 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
Investigators for the study have not yet decided on data sharing.


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.