Monitoring Of REgional Cerebral Oxygenation (rcSO2 ) With Near INFrared SpectrOscopy (NIRS) During Non-cardiac Surgery in Preterms, Neonates and Infants in Addition to Standard Monitoring to Guide Intraoperative Management
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebral Oxygenation
- Sponsor
- Medical University of Graz
- Enrollment
- 40
- Primary Endpoint
- Cerebral hypoxic burden
- Status
- Withdrawn
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Cerebral hypoxic burden
Time Frame: 1 day
Time under 65% cerebral oxygen saturation
Secondary Outcomes
- Fluid administration(1 day)
- Number of participants with Vasopressor or Inotrope administered(1 day)
- Number of participants with erythrocyte administration(1 day)
- Fraction of inspired oxygen(1 day)