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Clinical Trials in Italy / NCT06515080
Starting soon Observational

Predicting Outcomes Using Infra-red SEnsors, a Feasibility Study.

NCT06515080 · tracked via the Priya Life Science Italy tracker
Sponsor
Uppsala University
Phase
Observational
Started
2025-03-31
Last updated
2025-02-24

Condition(s) studied

General Anesthetic Drug Adverse Reaction

Investigational drug(s) / intervention(s)

Near Red Infrascopy

Near Red Infrascopy: Monitor of regional cerebral oxygen saturation

Study summary

The aim of this study is to investigate if it is feasible to use a protocol in which avoiding oxygen desaturation in the brain during general anaesthesia can reduce the risk of negative postoperative behavior changes in children.

We will recruit children from at least five centres around the world for this feasibility study. Brain oxygenation will be monitored with Near Red Infrascopy (NIRS) which is like a saturation monitor placed on the forehead of the child during anesthesia. The anesthesia is done as per routine, but we will ask the anesthesiologist to record what actions they took when there were signs of decreasing oxygen saturation in the brain. We will also ask the parents to fill in a questionnaire with 27 questions about changes in their child's behavior 7 days after the operation.

Eligibility

Sex
ALL
Min age
6 Months
Max age
59 Months
Healthy volunteers
No
Inclusion Criteria: * Children scheduled for both elective and non-elective, non-cardiac surgical procedures under general anaesthesia. Exclusion Criteria: * age \< 6 months or ≥ 59 months * procedures requiring \< 30 minutes of general anaesthesia * imaging procedures * procedures involving neurosurgery, oncology or burns * procedures involving significant pain lasting for more than 1 week on average (e.g. tonsillectomies, major orthopaedic surgery) * other procedures that limit access to the forehead * children that are on supplemental oxygen, are sedated or intubated at the time of inclusion * children with severe developmental delay * procedures with planned postoperative intensive care or hospital stay \> 3 days

Primary outcome measure(s)

  • the incidence of technical problems with NIRS monitoring and the parental noncompliance with PHBQ reporting. Checklist — From the beginning of the anesthesia until 30 days postoperatively
    The primary outcome is the feasibility

Trial sites (5)

FacilityCityRegionStatus
Perth Children´s Hospital Perth Western Australia
Universitet Brussel Brussels Belgium
University of Sao Paolo São Paulo Brazil
Istituto Gaslini Genova Italy
Uppsala University Hospital Uppsala Sweden

More Uppsala University trials in Italy

Postoperative Acute Kidney Injury in Children Undergoing Major Non-cardiac Surgery Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06515080 on ClinicalTrials.gov ↗ ← All trials in Italy