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Cerebral NIRS Monitoring During Anesthesia in Neonates and Infants

M

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

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.

Trial contacts and locations

0

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Central trial contact

Stefan Heschl, M.D., Ph.D.

Data sourced from clinicaltrials.gov

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