ANZCTR - Registration

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12618000059268

Ethics application status

Approved

Date submitted

27/11/2017

Date registered

17/01/2018

Date last updated

30/06/2024

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hypoglycaemia related to preoperative fasting

Condition category

Condition code

Anaesthesiology

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]

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]

Incidence of hypoglycaemic events on induction
Hypoglycaemia defined as <3.0mmol/L as assessed by Hand-held glucometer

Timepoint [1]

At Induction of Anaesthesia

Primary outcome [2]

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]

End of Surgery

Primary outcome [3]

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]

At end of surgery

Secondary outcome [1]

To assess the adherence to the fasting guidelines in all 3 hospitals
The fasting time for solids and liquid will be audited

Timepoint [1]

Day of surgery

Secondary outcome [2]

The difference in fasting glucose as measured by a handheld glucometer between the 3 hospitals

Timepoint [2]

At time of induction

Secondary outcome [3]

The difference in fasting ketone levels as measured by a handheld glucometer between the 3 hospitals

Timepoint [3]

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?

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

Completed

Date of first participant enrolment

Anticipated

1/02/2019

Actual

27/03/2019

Date of last participant enrolment

Anticipated

31/01/2021

Actual

31/08/2021

Date of last data collection

Anticipated

31/01/2021

Actual

31/08/2021

Sample size

Target

200

Accrual to date

Final

158

Recruitment in Australia

Recruitment state(s)

QLD,VIC

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Society for Paediatric Anaesthetist of New Zealand and Australia (SPANZA)

Address [1]

PO Box 180
Morisset NSW 2264

Country [1]

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]

Hospital

Name [1]

Gold Coast Univeristy Hospital

Address [1]

1 Hospital Boulevard
Southport
Queensland
4215

Country [1]

Australia

Secondary sponsor category [2]

Hospital

Name [2]

Royal Children's hospital

Address [2]

50 Flemington Road
Parkville
Victoria
3052

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children’s Health Queensland Hospital and Health Services HREC

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

29/12/2017

Approval date [1]

27/02/2018

Ethics approval number [1]

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

Dr Abigail Wong

Address

Department of Anaesthesia, Gold Coast University Hospital, Southport, Gold Coast, Queensland 4125

Country

Australia

Phone

+61 756875626

Fax

[email protected]

Contact person for public queries

Name

Abigail Wong

Address

Department of Anaesthesia, Gold Coast University Hospital, Southport, Gold Coast, Queensland 4125

Country

Australia

Phone

+61 756875626

Fax

[email protected]

Contact person for scientific queries

Name

Abigail Wong

Address

Department of Anaesthesia, Gold Coast University Hospital, Southport, Gold Coast, Queensland 4125

Country

Australia

Phone

+61 756875626

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically