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

NCT06515080 | Not Yet Recruiting

• 1 other identifier: PORPOISE Feasibility
• Study Type: observational
• Target: 500
• Locations: 5 countries
• Sites: 5

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.

Conditions

General Anesthetic Drug Adverse Reaction

Keywords

regional oxygen saturation

Outcome Measures

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

  From the beginning of the anesthesia until 30 days postoperatively

Secondary Outcomes (2)

• CrsO2

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

• Negative postoperative behavior changes (NPOBC)

  7 to 30 days postoperatively

Study Arms (1)

Children/Anesthesia

Diagnostic Test: Near Red Infrascopy

Interventions

Near Red Infrascopy DIAGNOSTIC_TEST

Monitor of regional cerebral oxygen saturation

Children/Anesthesia

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children undergoing routine general anesthesia

You may qualify if:

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

You may not qualify if:

• 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 with severe developmental delay
• procedures with planned postoperative intensive care or hospital stay \> 3 days

Sponsors & Collaborators

• Uppsala University: lead
• The University of Western Australia: collaborator
• University of Sao Paulo: collaborator
• Universitair Ziekenhuis Brussel: collaborator
• Uppsala County Council, Sweden: collaborator
• Istituto Giannina Gaslini: collaborator

Study Sites (5)

Perth Children´s Hospital

Perth, Western Australia, 6009, Australia

Location

Universitet Brussel

Brussels, 1050, Belgium

Location

University of Sao Paolo

São Paulo, Brazil

Location

Istituto Gaslini

Genova, 16147, Italy

Location

Uppsala University Hospital

Uppsala, 75185, Sweden

Location

Related Publications (4)

• 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.

  PMID: 36512036 BACKGROUND

• 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.

  PMID: 30737038 BACKGROUND

• 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.

  PMID: 30782342 BACKGROUND

• 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.

  PMID: 37173202 BACKGROUND

Study Officials

• Peter Frykholm, M.D., Ph.D.

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Frykholm, M.D., Ph.D.

CONTACT

+46186171240; peter.frykholm@uu.se

Ali-Reza Modiri, Ph.D.

CONTACT

+46186110000; ali-reza.modiri@uu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: March 31, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); BE (1); IT (1); SE (1); BR (1)