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

ConditionGeneral Anesthetic Drug Adverse Reaction
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

This trial does not accept healthy volunteers

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 population

Children undergoing routine general anesthesia

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Near Red Infrascopy

    Diagnostic test

    Monitor of regional cerebral oxygen saturation

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Children/Anesthesia1 intervention

Trial outcomes

Primary outcomes

1

the incidence of technical problems with NIRS monitoring and the parental noncompliance with PHBQ reporting. Checklist

The primary outcome is the feasibility

Time frame
From the beginning of the anesthesia until 30 days postoperatively

Secondary outcomes

1

CrsO2

Cerebral regional oxygen saturation monitored with NIRS

Time frame
From immediately before anesthesia induction until a few minutes after extubating up to 10 minutes
2

Negative postoperative behavior changes (NPOBC)

Negative postoperative behavior changes detected by asking the parents to report changes of behavior assessed with the Post Hospitalization Behavior Questionnaire (PHBQ) at day 7 and day 30 postop

Time frame
7 to 30 days postoperatively

Other outcomes

Sponsors and contacts

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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

This trial is not recruiting at the moment. You can still explore other options: