Cerebral NIRS Monitoring During Anesthesia in Neonates and Infants
- Conditions
- Cerebral Oxygenation
- Interventions
- Diagnostic Test: NIRS open
- Registration Number
- NCT04132414
- Lead Sponsor
- Medical University of Graz
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- Expected duration of Anesthesia >45 minutes
- Intervention/surgery in the operating room
- Impossibility to place cerebral NIRS sensor
- Known cerebral pathology
- Missing parental consent
- Congenial cardiac condition with right to left shunt
- Cardiac surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NIRS open NIRS open Cerebral NIRS monitoring applied and visible to caregiver. Interventions according to protocol in phases of cerebral hypoxia
- Primary Outcome Measures
Name Time Method Cerebral hypoxic burden 1 day Time under 65% cerebral oxygen saturation
- Secondary Outcome Measures
Name Time Method Number of participants with Vasopressor or Inotrope administered 1 day Proportion
Fluid administration 1 day ml/kg
Fraction of inspired oxygen 1 day Number of participants with erythrocyte administration 1 day Proportion