Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000059268
Ethics application status
Approved
Date submitted
27/11/2017
Date registered
17/01/2018
Date last updated
12/08/2019
Date data sharing statement initially provided
12/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Blood Glucose and Ketone levels on fasting children between 6 to 12 months for elective surgery
Scientific title
Blood Glucose and Ketone levels on fasting children between 6 to 12 months for elective surgery
Secondary ID [1] 293308 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoglycaemia related to preoperative fasting
 305391 0
Condition category
Condition code
Anaesthesiology 304677 304677 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Testing of blood sugar and ketone levels at induction of anaesthesia and end of anaesthesia
Intervention code [1] 299568 0
Not applicable
Comparator / control treatment
All infants that fulfil inclusion criteria will be included providing informed consent has been gained. We will be comparing the different fasting protocols between RCH and LCCH (GCUH follows LCCH protocol)
LCCH fasting guideline for 6 -12 months are 6 hour for solids, 4 hours for breast milk and 2 hours for clear fluids.
RCH fasting guideline for 6-12 months are 6 hours solids and 1 hours for clear fluid.
GCUH which is the 3rd hospital has identical guidelines to LCCH. We will be looking at LCCH and GCUH as a combined group as fasting guidelines are identical.
Control group
Active

Outcomes
Primary outcome [1] 303894 0
Incidence of hypoglycaemic events on induction
Hypoglycaemia defined as <3.0mmol/L as assessed by Hand-held glucometer
Timepoint [1] 303894 0
At Induction of Anaesthesia
Primary outcome [2] 304170 0
The impact of surgical stress is on the blood sugar levels measured with hand held glucometer in this age group at the end of the case. Surgical stress is measured by any increase in blood sugar from the induction of anaesthesia to the end of case.
Timepoint [2] 304170 0
End of Surgery
Primary outcome [3] 304171 0
The impact of surgical stress is on the ketones levels measured with hand held glucometer in this age group at the end of the case.
Timepoint [3] 304171 0
At end of surgery
Secondary outcome [1] 340373 0
To assess the adherence to the fasting guidelines in all 3 hospitals
The fasting time for solids and liquid will be audited
Timepoint [1] 340373 0
Day of surgery
Secondary outcome [2] 341893 0
The difference in fasting glucose as measured by a handheld glucometer between the 3 hospitals
Timepoint [2] 341893 0
At time of induction
Secondary outcome [3] 341899 0
The difference in fasting ketone levels as measured by a handheld glucometer between the 3 hospitals
Timepoint [3] 341899 0
At time of induction

Eligibility
Key inclusion criteria
1. Age range: 6-12 months of age
2. ASA Score: 1-2
3. Type of Surgery: Elective
Minimum age
6 Months
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Children who are on medications which may affect blood ketones or sugar
2. Children who have diabetes mellitus or other glycaemic disorders
3. Children who have metabolic disorders including but not limited to glycogen storage disease and hyperinsulinaemia
4. Children undergoing Medical Imaging procedures

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2019
Actual
27/03/2019
Date of last participant enrolment
Anticipated
31/01/2021
Actual
Date of last data collection
Anticipated
31/01/2021
Actual
Sample size
Target
200
Accrual to date
42
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC

Funding & Sponsors
Funding source category [1] 297933 0
Charities/Societies/Foundations
Name [1] 297933 0
Society for Paediatric Anaesthetist of New Zealand and Australia (SPANZA)
Country [1] 297933 0
Australia
Primary sponsor type
Hospital
Name
Lady Cilento Children's Hospital
Address
Department of Anaesthesia and Pain Management
501 Stanley Street
South Brisbane
QLD 4104
Country
Australia
Secondary sponsor category [1] 297073 0
Hospital
Name [1] 297073 0
Gold Coast Univeristy Hospital
Address [1] 297073 0
1 Hospital Boulevard
Southport
Queensland
4215
Country [1] 297073 0
Australia
Secondary sponsor category [2] 297074 0
Hospital
Name [2] 297074 0
Royal Children's hospital
Address [2] 297074 0
50 Flemington Road
Parkville
Victoria
3052
Country [2] 297074 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298979 0
Children’s Health Queensland Hospital and Health Services HREC
Ethics committee address [1] 298979 0
Human research ethics committee
Centre for Children’s Health Research
Queensland Children’s hospital precinct
Level 7
62 Graham Street
South Brisbane
QLD 4101
Ethics committee country [1] 298979 0
Australia
Date submitted for ethics approval [1] 298979 0
29/12/2017
Approval date [1] 298979 0
27/02/2018
Ethics approval number [1] 298979 0

Summary
Brief summary
Perioperative hypoglycaemia during elective surgery can potentially cause serious consequences. In neonates, hypoglycaemia can cause lethargy, apnoea, seizures and coma (Pediatrics, 2011; 127(3): 575-579). In severe cases, neurodevelopment in neonates is impaired with white matter changes, haemorrhage, infarction and basal ganglia changes seen on MRI. (Pediatrics, 2008; 122(1)). A recent study has shown that children, especially infants, can be ketotic and have low normal BSL (Blood sugar level) following preoperative fasting periods (Eur J Anaesthesiol 2015; 32:857–861). Anecdotal reports at Royal Children's Hospital have indicated that children between 6-12 months may be at a higher risk of hypoglycaemia due to prolong preoperative fasting and physiology which has resulted in BSL in the 1.0-2.0 range which required urgent intervention perioperatively. There is belief that the stress response of surgery will mitigate the potential hypoglycaemic effects of fasting however, there are lack of literature to show the effect in this age group. There is a current lack of consensus regarding best practice fasting guidelines. Young children are extremely vulnerable to the risk of preoperative hypoglycaemia and determining evidence based fasting guidelines could have significant benefits for the patient and department.
Methods. Using a prospective observational design of 200 infants, aged 6-12months with an ASA (American Society of Anaesthesiologist Score)of 1-2, and undergoing elective surgery will be observed during the perioperative period for hypoglycemia. Blood of around 6 microliters will be obtained to test blood sugar and ketones using commercially available handheld point of care testers at induction after insertion of IV cannula. Hypoglycemia will be defined as a BSL of 3.0mmol or less and hypoglycaemia will be treated as per local guidelines. On completion of surgery, a further 6 microliters will be obtained to test for blood sugar and ketones using the same testers.

Outcome. Primary outcome is incidence of hypoglycemic events on induction. Secondary outcomes are change in BSL and ketone levels during the perioperative period.

Sample size calculations were carried out using the G*Power software. We are planning to recruit a total of 200 children where 100 at Royal Children's hospital (RCH) and 50 each at both Lady Cilento Children's Hospital (LCCH) and Gold Coast University Hospital (GCUH) as per calculations.

Statistics. Analyses will in the first instance compare LCCH and RCH patients, and hence their different fasting protocols, with respect to BSL and ketones by means of two sample t-tests immediately before and after anaesthesia. Linear regression analyses will also be undertaken to take into consideration the various covariates that may impact on BSL and ketones
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78874 0
Dr Abigail Wong
Address 78874 0
Department of Anaesthesia and Pain Management
Level 7
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane
Queensland 4101
Country 78874 0
Australia
Phone 78874 0
+61 7 3068 1358
Fax 78874 0
Email 78874 0
[email protected]
Contact person for public queries
Name 78875 0
Dr Abigail Wong
Address 78875 0
Department of Anaesthesia and Pain Management
Level 7
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane
Queensland 4101
Country 78875 0
Australia
Phone 78875 0
+61 7 3068 1358
Fax 78875 0
Email 78875 0
[email protected]
Contact person for scientific queries
Name 78876 0
Dr Abigail Wong
Address 78876 0
Department of Anaesthesia and Pain Management
Level 7
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane
Queensland 4101
Country 78876 0
Australia
Phone 78876 0
+61 7 3068 1358
Fax 78876 0
Email 78876 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
Not part of the study


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.