Predicting Outcomes Using Infra-red SEnsors, a Feasibility Study.
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-59
SponsorUppsala University
About this trial
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 criteria
Qualifiers
Children scheduled for both elective and non-elective, non-cardiac surgical procedures under general anaesthesia.
Disqualifiers
age < 6 months or ≥ 59 months
procedures requiring < 30 minutes of general anaesthesia
imaging procedures
procedures involving neurosurgery, oncology or burns
Trial design
Treatments tested in this trial
- Near Red Infrascopy
Treatment groups
500 Participants
are divided into 1 treatment groupSponsors and collaborators
Uppsala University
Lead sponsor
The University of Western Australia
Collaborator
University of Sao Paulo
Collaborator
Universitair Ziekenhuis Brussel
Collaborator
Uppsala County Council, Sweden
Collaborator
Istituto Giannina Gaslini
Collaborator
Source ClinicalTrials.gov