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NOT YET RECRUITING
NCT06515080

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

Sponsor: Uppsala University

View on ClinicalTrials.gov

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.

Official title: Physiological Monitoring in the OR; Predicting Outcomes Using Infra-red SEnsors, a Feasibility Study.

Key Details

Gender

All

Age Range

6 Months - 59 Months

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2025-03-31

Completion Date

2026-07-31

Last Updated

2025-02-24

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Near Red Infrascopy

Monitor of regional cerebral oxygen saturation

Locations (5)

Perth Children´s Hospital

Perth, Western Australia, Australia

Universitet Brussel

Brussels, Belgium

University of Sao Paolo

São Paulo, Brazil

Istituto Gaslini

Genova, Italy

Uppsala University Hospital

Uppsala, Sweden