Chesnut Randall, Temkin Nancy, Pridgeon James, Sulzbacher Stephen, Lujan Silvia, Videtta Walter, Moya-Barquín Luis, Chaddock Kelley, Bonow Robert, Petroni Gustavo, Guadagnoli Nahuel, Hendrickson Peter, Ramírez Cortez Grimaldo, Carreazo Nilton Yhuri, Vargas Aymituma Alcides, Anchante Daniel, Caqui Patrick, Ramírez Alberto, Munaico Abanto Manuel, Ortiz Chicchon Manuel, Cenzano Ramos José, Mazate-Mazariegos Analy, Castro Darce María Del Carmen, Sierra Morales Roberto, Brol Lopez Pedro, Menendez Willy, Posadas Gutierrez Sofía, Kevin Vicente, Mazariegos Andrea, de Leon Elie, Rodas Barrios Rodolfo Enrique, Rodríguez Sandra, Flores Sandra, Alvarado Ovidio, Guzman Flores Luis José, Moisa Martinez Melvin, Gonzalez Pablo
Department of Neurological Surgery, University of Washington, Seattle , Washington , USA.
Department of Orthopaedic Surgery, University of Washington, Seattle , Washington , USA.
Neurosurgery. 2024 Jan 1;94(1):65-71. doi: 10.1227/neu.0000000000002582. Epub 2023 Jul 6.
Traumatic 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.
A 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.
Primary 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.
This 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.
创伤性脑损伤（TBI）是一个重大的全球公共卫生问题。它是全球儿童和青少年死亡及残疾的主要原因。尽管颅内压（ICP）升高在小儿创伤性脑损伤后很常见，且与死亡及不良预后相关，但目前基于颅内压的管理的疗效仍存在争议。我们旨在提供I类证据，以检验基于当前颅内压监测管理的方案与基于影像学和临床检查而不进行颅内压监测的护理方案在小儿重度创伤性脑损伤中的疗效。
在中美洲和南美洲的重症监护病房进行一项III期、多中心、平行组、随机优效性试验，以确定对1至12岁重度创伤性脑损伤（年龄相匹配的格拉斯哥昏迷量表评分≤8）儿童进行随机分组，接受基于颅内压或非基于颅内压管理对其6个月预后的影响。
主要结局是6个月时的儿童生活质量。次要结局包括3个月时的儿童生活质量、死亡率、3个月和6个月时的儿童扩展格拉斯哥预后评分、重症监护病房住院时间以及针对治疗已测量或疑似颅内高压的干预次数。
这不是一项关于了解重度创伤性脑损伤中颅内压价值的研究。本研究问题基于方案。我们正在研究在全球重度小儿创伤性脑损伤人群中，基于方案的颅内压管理相对于基于影像学和临床检查的治疗的附加价值。证明疗效应能使重度小儿创伤性脑损伤的颅内压监测标准化。其他结果应促使重新评估在神经创伤护理中应如何以及对哪些患者应用颅内压数据。
