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. 2024 Jan 1;94(1):72-79.
doi: 10.1227/neu.0000000000002760. Epub 2023 Nov 13.

Development of a Randomized Trial Comparing ICP-Monitor-Based Management of Severe Pediatric Traumatic Brain Injury to Management Based on Imaging and Clinical Examination Without ICP Monitoring-Research Algorithms

Randall Chesnut  1   2   3   4 , Nancy Temkin  1   5 , James Pridgeon  1 , Stephen Sulzbacher  6 , Silvia Lujan  7   8 , Walter Videtta  9 , Luis Moya-Barquín  10 , Kelley Chaddock  1 , Robert H Bonow  1 , Gustavo Petroni  7   8 , Nahuel Guadagnoli  7   8 , Peter Hendrickson  1 , Grimaldo Ramírez Cortez  11 , Nilton Yhuri Carreazo  11   12 , Alcides Vargas Aymituma  11 , Daniel Anchante  13 , Patrick Caqui  13 , Alberto Ramírez  13 , Manuel Munaico Abanto  14 , Manuel Ortiz Chicchon  14 , José Cenzano Ramos  14 , María Del Carmen Castro Darce  10 , Roberto Sierra Morales  10 , Pedro Brol Lopez  10 , Willy Menendez  15 , Sofía Posadas Gutierrez  15 , Vicente Kevin  15 , Andrea Mazariegos  16 , Elie de Leon  16 , Rodolfo Enrique Rodas Barrios  16 , Sandra Rodríguez  17 , Sandra Flores  17 , Ovidio Alvarado  17 , Luis José Guzman Flores  18 , Melvin Moisa Martinez  18 , Pablo Gonzalez  18
Affiliations

Development of a Randomized Trial Comparing ICP-Monitor-Based Management of Severe Pediatric Traumatic Brain Injury to Management Based on Imaging and Clinical Examination Without ICP Monitoring-Research Algorithms

Randall Chesnut et al. Neurosurgery. .

Abstract

Background and objectives: The efficacy of our current approach to incorporating intracranial pressure (ICP) data into pediatric severe traumatic brain injury (sTBI) management is incompletely understood, lacking data from multicenter, prospective, randomized studies. The National Institutes of Health-supported Benchmark Evidence from Latin America-Treatment of Raised Intracranial Pressure-Pediatrics trial will compare outcomes from pediatric sTBI of a management protocol based on ICP monitoring vs 1 based on imaging and clinical examination without monitoring. Because no applicable comprehensive management algorithms for either cohort are available, it was necessary to develop them.

Methods: A consensus conference involving the 21 intensivists and neurosurgeons from the 8 trial sites used Delphi-based methodology to formulate management algorithms for both study cohorts. We included recommendations from the latest Brain Trauma Foundation pediatric sTBI guidelines and the consensus-based adult algorithms (Seattle International Brain Injury Consensus Conference/Consensus Revised Imaging and Clinical Examination) wherever relevant. We used a consensus threshold of 80%.

Results: We developed comprehensive management algorithms for monitored and nonmonitored cohort children with sTBI. We defined suspected intracranial hypertension for the nonmonitored group, set minimum number and timing of computed tomography scans, specified minimal age-adjusted mean arterial pressure and cerebral perfusion pressure targets, defined clinical neuroworsening, described minimal requisites for intensive care unit management, produced tiered management algorithms for both groups, and listed treatments not routinely used.

Conclusion: We will study these protocols in the Benchmark Evidence from Latin America-Treatment of Raised Intracranial Pressure-Pediatrics trial in low- and middle-income countries. Second, we present them here for consideration as prototype pediatric sTBI management algorithms in the absence of published alternatives, acknowledging their limited evidentiary status. Therefore, herein, we describe our study design only, not recommended treatment protocols.

Trial registration: ClinicalTrials.gov NCT05566431.

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References

    1. Chesnut RM, Temkin N, Carney N, et al. A trial of intracranial-pressure monitoring in traumatic brain injury. N Engl J Med. 2012;367(26):2471-2481. - PMC - PubMed
    1. Chesnut RM, Bleck TP, Citerio G, et al. A consensus-based interpretation of the benchmark evidence from South American trials: treatment of intracranial pressure trial. J Neurotrauma. 2015;32(22):1722-1724. - PubMed
    1. Kochanek PM, Tasker RC, Bell MJ, et al. Management of pediatric severe traumatic brain injury: 2019 consensus and guidelines-based algorithm for first and second tier therapies. Pediatr Crit Care Med. 2019;20(3):269-279. - PubMed
    1. Kochanek PM, Tasker RC, Carney N, et al. Guidelines for the management of pediatric severe traumatic brain injury, third edition: update of the brain trauma foundation guidelines. Pediatr Crit Care Med. 2019;20(3S Suppl 1):S1–s82. - PubMed
    1. Chesnut RM, Temkin N, Videtta W, et al. Consensus-based management protocol (CREVICE Protocol) for the Treatment of severe traumatic brain injury based on imaging and clinical examination for use when intracranial pressure monitoring is not employed. J Neurotrauma. 2020;37(11):1291-1299. - PMC - PubMed

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