Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000292673
Ethics application status
Approved
Date submitted
12/03/2014
Date registered
20/03/2014
Date last updated
12/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Cerebral near-infrared spectroscopy monitoring in infants during the peri-operative period: a prospective observational cohort study
Scientific title
Infants undergoing near-infrared spectroscopy monitoring to measure cerebral deoxygenation during surgery
Secondary ID [1] 284254 0
None
Universal Trial Number (UTN)
Trial acronym
The NIRS study: oxygen monitoring of children during surgery
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral deoxygenation 291372 0
Neurodevelopmental outcome 291373 0
Condition category
Condition code
Anaesthesiology 291737 291737 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cerebral near-infared spectroscopy (NIRS) monitoring during surgery. In the study two NIRS sensors will be placed on the participants' foreheads to measure cerebral deoxygenation. We will place the NIRS sensors pre-operatively and record NIRS measurements pre, intra and post operatively until the participant fully awakes. We will be enrolling children who are expected to undergo surgery of at least 30 minutes duration.
Intervention code [1] 288961 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291670 0
Cerebral oxygenation levels
Timepoint [1] 291670 0
Perioperative period (pre, intra and post-operatively).
We will record the NIRS for a short period pre-operatively (5-10 minutes) while the participant is awake and resting quietly. We will record NIRS post-operatively until the participant fully awakes (or up to a maximum of 30 minutes).
Secondary outcome [1] 307265 0
Blood pressure readings will be recorded using a manual sphygomanometer pre and post-operatively. We will use an automatic sphygomanometer to record blood pressure intraoperatively. Where possible, we will also record intra-arterial blood pressure to allow high frequency analysis.
Timepoint [1] 307265 0
Several blood pressure readings will be recorded over a 5-10 minute period pre-operatively when the child is awake and resting. Blood pressure readings will be recorded every 2.5 minutes pre-operatively. We will also collect blood pressure readings post-operatively until the child fully awakes (or up to a maximum of 30 minutes).

Eligibility
Key inclusion criteria
Infants aged less than 6 months of age (corrected) scheduled for anaesthesia that is expected to last longer than 30 minutes duration.
Minimum age
1 Days
Maximum age
6 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Children where application of the NIRS would be impractical: for example surgery on the head or neck of the child.
2. Children scheduled for cardiac surgery
3. Children with known major cardiovascular shunting
4. Children with known neurological abnormalities

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The sample size is largely driven by what is logistically feasible. Initially we wish to aim for recruiting 240 subjects.
The first analysis is simply to identify the recruitment rate and note difficulties in placing the NIRS and obtaining artifact free data. Theatre is an electronically “busy” environment so it is important to establish that we can record substantial amounts of artifact free recording before planning larger studies. The next analysis is to record the frequency of deoxygenation. Depending on the frequency of deoxygenation we should be able to perform regression analyses to explore the association between risk factors and deoxygenation.
In a subset of children we shall have high fidelity invasive blood pressure data. In these children we shall collect data that may be used in future to determine greater details about the relationship between blood pressure and NIRS to help identify autoregulatory thresholds.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/04/2014
Actual
15/07/2014
Date of last participant enrolment
Anticipated
30/04/2016
Actual
31/05/2016
Date of last data collection
Anticipated
Actual
31/05/2016
Sample size
Target
240
Accrual to date
Final
215
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2185 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [2] 3648 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 3649 0
Princess Margaret Hospital - Subiaco
Recruitment postcode(s) [1] 7864 0
3052 - Parkville
Recruitment postcode(s) [2] 9486 0
2145 - Westmead
Recruitment postcode(s) [3] 9487 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 288880 0
Hospital
Name [1] 288880 0
Department of Anaesthesia and Pain Management
Royal Children's Hospital
Country [1] 288880 0
Australia
Funding source category [2] 294696 0
Charities/Societies/Foundations
Name [2] 294696 0
Australian & New Zealand College of Anaesthetists
Country [2] 294696 0
Australia
Primary sponsor type
Hospital
Name
The Royal Children's Hospital Melbourne
Address
Flemington Road
Parkville
VIC 3052
Country
Australia
Secondary sponsor category [1] 287573 0
Charities/Societies/Foundations
Name [1] 287573 0
Murdoch Childrens Research Insitute
Address [1] 287573 0
Flemington Road
Parkville
VIC 3052
Country [1] 287573 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290709 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 290709 0
Flemington Road
Parkville
VIC 3052
Ethics committee country [1] 290709 0
Australia
Date submitted for ethics approval [1] 290709 0
12/03/2014
Approval date [1] 290709 0
18/06/2014
Ethics approval number [1] 290709 0
34055A

Summary
Brief summary
Surgery and anaesthesia in infants is associated with a small but definite increased risk of brain injury. The reasons for this are very unclear. One reason may be that the infant does not receive enough oxygen to the brain during the operation. This in turn may be because the blood pressure is not optimal – the blood pressure often falls during anaesthesia in infants. This study hopes to use a new technology known as NIRS (near infrared spectroscopy) to try and see which infants are at risk and why. NIRS consists of a device that shines a red light through the infant’s skull into their brain. The amount of light reflected back gives an indication of how much oxygen is in the brain tissue.
In this study we shall attach the NIRS to infants having routine surgery to see if the brain oxygen levels fall and what tends to make the levels fall. We also hope to be able to compute how blood pressure is related to levels of brain oxygen in infants during surgery. Eventually we hope this technology will help develop techniques to ensure brain oxygen levels are kept optimal and hopefully the risk of brain injury reduced.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46902 0
Prof Andrew Davidson
Address 46902 0
Department of Anaesthesia and Pain Management
Royal Children's Hospital
Flemington Road
Parkville
VIC 3052
Country 46902 0
Australia
Phone 46902 0
+61393455233
Fax 46902 0
Email 46902 0
[email protected]
Contact person for public queries
Name 46903 0
Ms Suzette Sheppard
Address 46903 0
Department of Anaesthesia and Pain Management
Royal Children's Hospital
Flemington Road
Parkville
VIC 3052
Country 46903 0
Australia
Phone 46903 0
+61393455233
Fax 46903 0
Email 46903 0
[email protected]
Contact person for scientific queries
Name 46904 0
Prof Andrew Davidson
Address 46904 0
Department of Anaesthesia and Pain Management
Royal Children's Hospital
Flemington Road
Parkville
VIC 3052
Country 46904 0
Australia
Phone 46904 0
+61393455233
Fax 46904 0
+61393456003
Email 46904 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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