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

NCT06515080 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-02-24

No results posted yet for this 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.

Conditions

  • General Anesthetic Drug Adverse Reaction

Interventions

DIAGNOSTIC_TEST

Near Red Infrascopy

Monitor of regional cerebral oxygen saturation

Sponsors & Collaborators

  • The University of Western Australia

    collaborator OTHER

  • University of Sao Paulo

    collaborator OTHER

  • Universitair Ziekenhuis Brussel

    collaborator OTHER

  • Uppsala County Council, Sweden

    collaborator OTHER_GOV

  • Istituto Giannina Gaslini

    collaborator OTHER

  • Uppsala University

    lead OTHER

Principal Investigators

  • Peter Frykholm, M.D., Ph.D. · Uppsala University

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2026-01-31
Completion
2026-07-31

Countries

  • Australia
  • Belgium
  • Brazil
  • Italy
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06515080 on ClinicalTrials.gov