Cerebral NIRS Monitoring During Anesthesia in Neonates and Infants

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Oxygenation
• Intervention / Treatment: Diagnostic test: NIRS open

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefan Heschl, M.D., Ph.D.; Phone Number: +4331638513027; Email: stefan.heschl@medunigraz.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NIRS open; Cerebral NIRS monitoring applied and visible to caregiver. Interventions according to protocol in phases of cerebral hypoxia	Diagnostic test: NIRS open; Treatment according to protocol in phases of cerebral hypoxia.
No Intervention: NIRS blinded; NIRS monitoring applied and masked for caregiver.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral hypoxic burden	Time under 65% cerebral oxygen saturation	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluid administration	ml/kg	1 day
Number of participants with Vasopressor or Inotrope administered	Proportion	1 day
Number of participants with erythrocyte administration	Proportion	1 day
Fraction of inspired oxygen		1 day

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Stefan Heschl, M.D., Ph.D., Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 31-175 ex 18/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No