• Neurosurgery · Jan 2024

    Protocol for a Randomized Trial Comparing Intracranial Pressure Monitor-Based Management of Severe Pediatric Traumatic Brain Injury With Management Based on Imaging and Clinical Examination Without Intracranial Pressure Monitoring.

    • Randall Chesnut, Nancy Temkin, James Pridgeon, Stephen Sulzbacher, Silvia Lujan, Walter Videtta, Luis Moya-Barquín, Kelley Chaddock, Robert Bonow, Gustavo Petroni, Nahuel Guadagnoli, Peter Hendrickson, Grimaldo Ramírez Cortez, CarreazoNilton YhuriNYHospital de Emergencias Pediátricas, Lima , Peru.Escuela de Medicina, Universidad Peruana de Ciencias Aplicadas, Lima , Peru., Alcides Vargas Aymituma, Daniel Anchante, Patrick Caqui, Alberto Ramírez, Manuel Munaico Abanto, Manuel Ortiz Chicchon, José Cenzano Ramos, Analy Mazate-Mazariegos, María Del Carmen Castro Darce, Roberto Sierra Morales, Pedro Brol Lopez, Willy Menendez, Sofía Posadas Gutierrez, Vicente Kevin, Andrea Mazariegos, Elie de Leon, Rodolfo Enrique Rodas Barrios, Sandra Rodríguez, Sandra Flores, Ovidio Alvarado, Luis José Guzman Flores, Melvin Moisa Martinez, and Pablo Gonzalez.
    • Department of Neurological Surgery, University of Washington, Seattle , Washington , USA.
    • Neurosurgery. 2024 Jan 1; 94 (1): 657165-71.

    Background And ObjectivesTraumatic brain injury (TBI) is a major global public health problem. It is a leading cause of death and disability in children and adolescents worldwide. Although increased intracranial pressure (ICP) is common and associated with death and poor outcome after pediatric TBI, the efficacy of current ICP-based management remains controversial. We intend to provide Class I evidence testing the efficacy of a protocol based on current ICP monitor-based management vs care based on imaging and clinical examination without ICP monitoring in pediatric severe TBI.MethodsA phase III, multicenter, parallel-group, randomized superiority trial performed in intensive care units in Central and South America to determine the impact on 6-month outcome of children aged 1-12 years with severe TBI (age-appropriate Glasgow Coma Scale score ≤8) randomized to ICP-based or non-ICP-based management.Expected OutcomesPrimary outcome is 6-month Pediatric Quality of Life. Secondary outcomes are 3-month Pediatric Quality of Life, mortality, 3-month and 6-month Pediatric extended Glasgow Outcome Score, intensive care unit length of stay, and number of interventions focused on treating measured or suspected intracranial hypertension.DiscussionThis is not a study of the value of knowing the ICP in sTBI. This research question is protocol-based. We are investigating the added value of protocolized ICP management to treatment based on imaging and clinical examination in the global population of severe pediatric TBI. Demonstrating efficacy should standardize ICP monitoring in severe pediatric TBI. Alternate results should prompt reassessment of how and in which patients ICP data should be applied in neurotrauma care.Copyright © Congress of Neurological Surgeons 2023. All rights reserved.

      Pubmed     Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…