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

Not yet recruiting

• Conditions: General Anesthetic Drug Adverse Reaction
• Interventions: Diagnostic Test: Near Red Infrascopy

• Registration Number: NCT06515080
• Lead Sponsor: Uppsala University

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 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.

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 children. Negative post-operative changes (NPOBC) represent a surrogate outcome for neurocognitive damage associated with hemodynamic changes during general anaesthesia. This is a feasibility study that will examine anaesthesia team´s reactions to changes in (1) regional cerebral oxygen saturation (crSO2) (2) systemic hypotension or hypoxaemia, while also reporting any technical issues with data acquisition. We will also estimate the incidence of negative post-operative changes and explore any association with reduced crSO2 in our patient population compared with previous international data. Specifically, this feasibility study will provide data for the robust design and power analysis of a large-scale, randomised interventional trial in children undergoing anaesthesia, with the utilisation of a protocol targeting cerebral oxygen desaturation vs a control group of standard care with no access to crSO2 monitoring.

Methods At least 500 children of ages 6 months - 59 months will be recruited from at least 5 centers around the world. Besides routine monitoring, cerebral regional oxygen saturation (crsO2 will be monitored throughout the procedure.

Primary outcome The primary outcome is the feasibility of successful data collection of crO2, physiological and PHBQ data in a larger population over multiple international sites. This includes the incidence of technical problems with NIRS monitoring and the parental noncompliance with PHBQ reporting will be determined.

Secondary outcomes:

* The incidence of reduced crSO2 below baseline (more than 10%)

* The area under the curve (AUC) of reduced crSO2 below baseline

* The incidence of negative postoperative behaviour changes as determined by the PHBQ administered on day 7 \& 30 following surgery.

* A set of threshold values for and form of interventions to restore cr02 and/or mean arterial blood pressure (Actions may include any of the following interventions fluid bolus, vasoactive agents, Trendelenburg position, adjustment of anaesthetic dose, and change of ventilation settings)

* The incidence of negative post-operative behavioural change and the extent of any association with the AUC of crSO2 below baseline

Study Timeline

• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Study Start: 2025-03-31
• Primary Completion: 2026-01-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Children scheduled for both elective and non-elective, non-cardiac surgical procedures under general anaesthesia.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children/Anesthesia	Near Red Infrascopy	-

Primary Outcome Measures

Name	Time	Method
the incidence of technical problems with NIRS monitoring and the parental noncompliance with PHBQ reporting. Checklist	From the beginning of the anesthesia until 30 days postoperatively	The primary outcome is the feasibility

Secondary Outcome Measures

Name	Time	Method
Negative postoperative behavior changes (NPOBC)	7 to 30 days postoperatively	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
CrsO2	From immediately before anesthesia induction until a few minutes after extubating up to 10 minutes	Cerebral regional oxygen saturation monitored with NIRS

Trial Locations

Locations (5)

Universitet Brussel; 🇧🇪 Brussels, Belgium

University of Sao Paolo; 🇧🇷 Sao Paolo, Brazil

Perth Children´s Hospital; 🇦🇺 Perth, Western Australia, Australia

Istituto Gaslini; 🇮🇹 Genova, Italy

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden