Clinical trial NCT06515080: Predicting Outcomes Using Infra-red SEnsors, a Feasibility Study.
Official title: Physiological Monitoring in the OR; Predicting Outcomes Using Infra-red SEnsors, a Feasibility Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: General Anesthetic Drug Adverse Reaction
Keywords: regional oxygen saturation
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: The University of Western Australia
name: University of Sao Paulo
name: Universitair Ziekenhuis Brussel
name: Uppsala County Council, Sweden
name: Istituto Giannina Gaslini
First posted: 2024-07-23
Enrollment: 500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children undergoing routine general anesthesia

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* age \&lt; 6 months or ≥ 59 months

  * procedures requiring \&lt; 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 \&gt; 3 days

Primary outcomes:
measure: the incidence of technical problems with NIRS monitoring and the parental noncompliance with PHBQ reporting. Checklist
timeFrame: From the beginning of the anesthesia until 30 days postoperatively
Secondary outcomes:
measure: CrsO2
timeFrame: From immediately before anesthesia induction until a few minutes after extubating up to 10 minutes
measure: Negative postoperative behavior changes (NPOBC)
timeFrame: 7 to 30 days postoperatively
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Perth Children´s Hospital
state: Western Australia
city: Brussels
country: Belgium
facility: Universitet Brussel
city: Sao Paolo
country: Brazil
facility: University of Sao Paolo
city: Genova
country: Italy
facility: Istituto Gaslini
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University
name: Peter Frykholm, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spaeder MC, Keller JM, Sawda CN, Surma VJ, Platter EN, White DN, Smith CJ, Harmon WG. Implementation of a Regional Oxygen Saturation Thought Algorithm and Association with Clinical Outcomes in Pediatric Patients Following Cardiac Surgery. Pediatr Cardiol. 2023 Apr;44(4):940-945. doi: 10.1007/s00246-022-03071-z. Epub 2022 Dec 13.
citation: Gomez-Pesquera E, Poves-Alvarez R, Martinez-Rafael B, Liu P, Alvarez J, Lorenzo-Lopez M, Fierro I, Gomez-Sanchez E, Heredia-Rodriguez M, Gomez-Herreras JI, Tamayo E. Cerebral Oxygen Saturation and Negative Postoperative Behavioral Changes in Pediatric Surgery: A Prospective Observational Study. J Pediatr. 2019 May;208:207-213.e1. doi: 10.1016/j.jpeds.2018.12.047. Epub 2019 Feb 6.
citation: McCann ME, de Graaff JC, Dorris L, Disma N, Withington D, Bell G, Grobler A, Stargatt R, Hunt RW, Sheppard SJ, Marmor J, Giribaldi G, Bellinger DC, Hartmann PL, Hardy P, Frawley G, Izzo F, von Ungern Sternberg BS, Lynn A, Wilton N, Mueller M, Polaner DM, Absalom AR, Szmuk P, Morton N, Berde C, Soriano S, Davidson AJ; GAS Consortium. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): an international, multicentre, randomised, controlled equivalence trial. Lancet. 2019 Feb 16;393(10172):664-677. doi: 10.1016/S0140-6736(18)32485-1. Epub 2019 Feb 14.
citation: Jevtovic-Todorovic V, Useinovic N. Early exposure to general anaesthesia and increasing trends in developmental behavioural impairments: is there a link? Br J Anaesth. 2023 Aug;131(2):208-211. doi: 10.1016/j.bja.2023.04.005. Epub 2023 May 10.