Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000605190
Ethics application status
Approved
Date submitted
9/04/2019
Date registered
23/04/2019
Date last updated
7/11/2022
Date data sharing statement initially provided
23/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Brain Oxygenation changes during Heart Surgery
Scientific title
Changes in cerebral mitochondrial oxygenation during paediatric and adult cardiac surgery
Secondary ID [1] 297930 0
nil known
Universal Trial Number (UTN)
U1111-1231-4568
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Surgery 312317 0
Condition category
Condition code
Anaesthesiology 310882 310882 0 0
Anaesthetics
Cardiovascular 310990 310990 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients undergoing heart surgery will have their brain cytochrome oxygenation status monitoring using the miniCYRIL near infrared system, together with standard clinical monitoring. This data will not be available to clinicians. Monitoring will commence ten minutes prior to surgical incision, and conclude on application of surgical dressings at the end of the operation.
Intervention code [1] 314152 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319707 0
The correlation between cytochrome pressure reactivity and the autoregulation index COx will be determined using the methodology established by Highton(Adv Exp Med Biol, 2013) and Mitra(J Cer Blood Flow Met 2017), which, measures the similarity between blood pressure and [oxCCO] using a signal processing technique
Timepoint [1] 319707 0
during cardiopulmonary bypass
Secondary outcome [1] 369238 0
incidence of relative CCO (Cytochrome C Oxidase) deoxygenation during CPB (Cardiopulmonary Bypass), by two measurements: per patient event incidence (discrete reductions below baseline events per patient) and an area under the curve analysis (AUC for CCO<baseline reading per patient)
Timepoint [1] 369238 0
during cardiopulmonary bypass

Eligibility
Key inclusion criteria
adults and children undergoing heart surgery using cardiopulmonary bypass
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
cerebral and cranial malformations involving frontal bone and cortex.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Power analysis has been performed on the primary comparison, which is the Pearson correlation between COx and CCO pressure reactivity. This is the standard comparison used in the literature and studies range in size between 23-50 patients. The anticipated correlation is typically at least 0.5. The present research is powered to identify this. With 30 subjects this has a power of 0.8 to detect a 0.5 correlation at the p=0.05 level. (alpha=0.05, beta = 1-power=0.2). Therefore, 30 adult and 30 paediatric patients will be recruited.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2020
Actual
21/12/2020
Date of last participant enrolment
Anticipated
1/12/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
80
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 13582 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 13583 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 26241 0
2145 - Westmead
Recruitment postcode(s) [2] 26242 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 302446 0
Charities/Societies/Foundations
Name [1] 302446 0
Australian and New Zealand College of Anaesthetists
Country [1] 302446 0
Australia
Primary sponsor type
Individual
Name
Justin Skowno
Address
Department of anaesthesia, The Children's Hospital at Westmead, Hawkesbury Road Westmead, 2145, NSW
Country
Australia
Secondary sponsor category [1] 302348 0
None
Name [1] 302348 0
Address [1] 302348 0
Country [1] 302348 0
Other collaborator category [1] 280631 0
Individual
Name [1] 280631 0
Dr Ilias Tachtsidis
Address [1] 280631 0
Department of Medical Physics and Biomedical Engineering
University College London
Gower Street, London,
WC1E 6BT
United Kingdom
Country [1] 280631 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303115 0
The sydney childrens hospital human research ethics committee
Ethics committee address [1] 303115 0
Ethics committee country [1] 303115 0
Australia
Date submitted for ethics approval [1] 303115 0
17/05/2019
Approval date [1] 303115 0
25/11/2019
Ethics approval number [1] 303115 0
2019 /ETH09785

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

Contacts
Principal investigator
Name 92530 0
A/Prof Justin Skowno
Address 92530 0
Department of Anaesthesia
The Children's Hospital at Westmead
Hawkesbury Road
Westmead
2145
NSW
Country 92530 0
Australia
Phone 92530 0
+61 432648840
Fax 92530 0
Email 92530 0
[email protected]
Contact person for public queries
Name 92531 0
Justin Skowno
Address 92531 0
Department of Anaesthesia
The Children's Hospital at Westmead
Hawkesbury Road
Westmead
2145
NSW
Country 92531 0
Australia
Phone 92531 0
+61 432648840
Fax 92531 0
Email 92531 0
[email protected]
Contact person for scientific queries
Name 92532 0
Justin Skowno
Address 92532 0
Department of Anaesthesia
The Children's Hospital at Westmead
Hawkesbury Road
Westmead
2145
NSW
Country 92532 0
Australia
Phone 92532 0
+61 432648840
Fax 92532 0
Email 92532 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


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.