Cerebral near-infrared spectroscopy monitoring in infants during the peri-operative period: a prospective observational cohort study

Infants undergoing near-infrared spectroscopy monitoring to measure cerebral deoxygenation during surgery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12614000292673

Acronym

The NIRS study: oxygen monitoring of children during surgery

Enrollment

215

Registered

2014-03-20

Start date

2014-07-15

Completion date

2016-05-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Eligibility

Sex/Gender

All

Age

1 Days to 6 Months

Healthy volunteers

Inclusion criteria

Infants aged less than 6 months of age (corrected) scheduled for anaesthesia that is expected to last longer than 30 minutes duration.

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

Outcome results