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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06515080




Registration number
NCT06515080
Ethics application status
Date submitted
17/07/2024
Date registered
23/07/2024
Date last updated
22/11/2024

Titles & IDs
Public title
Predicting Outcomes Using Infra-red SEnsors, a Feasibility Study.
Scientific title
Physiological Monitoring in the OR; Predicting Outcomes Using Infra-red SEnsors, a Feasibility Study.
Secondary ID [1] 0 0
PORPOISE Feasibility
Universal Trial Number (UTN)
Trial acronym
PORPOISE-F
Linked study record

Health condition
Health condition(s) or problem(s) studied:
General Anesthetic Drug Adverse Reaction 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Near Red Infrascopy

Children/Anesthesia -


Diagnosis / Prognosis: Near Red Infrascopy
Monitor of regional cerebral oxygen saturation
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
the incidence of technical problems with NIRS monitoring and the parental noncompliance with PHBQ reporting. Checklist
Timepoint [1] 0 0
From the beginning of the anesthesia until 30 days postoperatively
Secondary outcome [1] 0 0
CrsO2
Timepoint [1] 0 0
From immediately before anesthesia induction until a few minutes after extubating up to 10 minutes
Secondary outcome [2] 0 0
Negative postoperative behavior changes (NPOBC)
Timepoint [2] 0 0
7 to 30 days postoperatively

Eligibility
Key inclusion criteria
* Children scheduled for both elective and non-elective, non-cardiac surgical procedures under general anaesthesia.
Minimum age
6 Months
Maximum age
59 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2026
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Perth Children´s Hospital - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Sao Paolo
Country [2] 0 0
Sweden
State/province [2] 0 0
Uppsala

Funding & Sponsors
Primary sponsor type
Other
Name
Uppsala University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of Western Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Sao Paulo
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Universitair Ziekenhuis Brussel
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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 25 questions about changes in their child's behavior 7 days after the operation.
Trial website
https://clinicaltrials.gov/study/NCT06515080
Trial related presentations / publications
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.
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.
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. Erratum In: Lancet. 2019 Aug 24;394(10199):638. doi: 10.1016/S0140-6736(19)31958-0.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Peter Frykholm, M.D., Ph.D.
Address 0 0
Uppsala University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Peter Frykholm, M.D., Ph.D.
Address 0 0
Country 0 0
Phone 0 0
+46186171240
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06515080