Status:
NOT_YET_RECRUITING
Predicting Outcomes Using Infra-red SEnsors, a Feasibility Study.
Lead Sponsor:
Uppsala University
Collaborating Sponsors:
The University of Western Australia
University of Sao Paulo
Conditions:
General Anesthetic Drug Adverse Reaction
Eligibility:
All Genders
6-59 years
Brief 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 ...
Detailed Description
This project will investigate the potential effect of a protocol, targeted at counteracting cerebral desaturation during anaesthesia, with the aim of reducing negative post-operative changes in childr...
Eligibility Criteria
Inclusion
- Children scheduled for both elective and non-elective, non-cardiac surgical procedures under general anaesthesia.
Exclusion
- 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
Key Trial Info
Start Date :
March 31 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06515080
Start Date
March 31 2025
End Date
July 31 2026
Last Update
February 24 2025
Active Locations (5)
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1
Perth Children´s Hospital
Perth, Western Australia, Australia, 6009
2
Universitet Brussel
Brussels, Belgium, 1050
3
University of Sao Paolo
São Paulo, Brazil
4
Istituto Gaslini
Genova, Italy, 16147