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ClinicalTrials.gov ID

NCT06515080

Lead Sponsor

Uppsala UniversityOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

500Estimated

Last Update Posted

Feb 24, 2025Actual

Start Date

Mar 31, 2025Estimated

Primary Completion Date

Jan 31, 2026Estimated

Completion Date

Jul 31, 2026Estimated

Official Title

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

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

• General Anesthetic Drug Adverse Reaction

• Near Red Infrascopy

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Uppsala UniversityOTHER

Collaborators

The University of Western AustraliaOTHER

University of Sao PauloOTHER

Universitair Ziekenhuis BrusselOTHER

Uppsala County Council, SwedenOTHER_GOV

Istituto Giannina GasliniOTHER

Nadia.Najafi@uzbrussel.be+32469160030

vinicius.quintao@hc.fm.us+55 11 97127-3950

nicoladisma@gaslini.org+39 338 2758043

peter.frykholm@uu.se+46186171240