Cerebral NIRS Monitoring During Anesthesia in Neonates and Infants

Medical University of Graz

Status: Not yet enrolling

Conditions: Cerebral Oxygenation

Treatments: Diagnostic Test: NIRS open

Study type: Interventional

Funder types: Other

Identifiers

NCT04132414

31-175 ex 18/19

Details and patient eligibility

About

The brain is a very vulnerable organ, especially in premature babies, newborns and infants. However, during anesthesia, the oxygenation of the brain can only be monitored indirectly and insufficiently. Near-infrared spectroscopy (NIRS) is an established monitoring method in other areas (e.g., neonatology, cardiac anesthesia), which provides non-invasive information about the regional oxygen supply of the brain. The integration of this monitoring device into the anaesthesiological care for neonates and infants could reduce the risk of cerebral hypoxia. The planned study investigates whether the use of NIRS in anesthetized children up to 6 months can prevent or influence the occurrence of cerebral hypoxia.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Expected duration of Anesthesia >45 minutes
• Intervention/surgery in the operating room

Exclusion criteria

• Impossibility to place cerebral NIRS sensor
• Known cerebral pathology
• Missing parental consent
• Congenial cardiac condition with right to left shunt
• Cardiac surgery

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

NIRS open

Experimental group

Description:

Cerebral NIRS monitoring applied and visible to caregiver. Interventions according to protocol in phases of cerebral hypoxia

Treatment:

Diagnostic Test: NIRS open

NIRS blinded

No Intervention group

Description:

NIRS monitoring applied and masked for caregiver.