BACKGROUND: Although in the developed world the intracranial pressure (ICP) monitor is considered the standard of care for patients with severe traumatic brain injury (TBI), its usefulness to direct treatment decisions has never been tested rigorously. OBJECTIVE: The primary focus was to conduct a high-quality, randomized, controlled trial to determine whether ICP monitoring used to direct TBI treatment improves patient outcomes. By providing education, equipment, and structure, the project will enhance the research capacity of the collaborating investigators and will foster the collaborations established during earlier studies. METHODS: Study centers were selected that routinely treated ICP based on clinical examination and computed tomography imaging using internal protocols. We randomized patients to either an ICP monitor group or an imaging and clinical examination group. Treatment decisions for the ICP monitor group are guided by ICP monitoring based on established guidelines. Treatment decisions for the imaging and clinical examination group are made using a single protocol derived from those previously being used at those centers. EXPECTED OUTCOMES: There are 2 study hypotheses: (1) patients with severe TBI whose acute care treatment is managed using ICP monitors will have improved outcomes and 2) incorporating ICP monitoring in the care of patients with severe TBI will minimize complications and decrease length of intensive care unit stay. DISCUSSION: This clinical trial tests the effectiveness of a management protocol based on technology considered pivotal to brain trauma treatment in the developed world: the ICP monitor. A randomized, controlled trial of ICP monitoring has never been performed-a critical gap in the evidence base that supports the role of ICP monitoring in TBI care. As such, the results of this randomized, controlled trial will have global implications regardless of the level of development of the trauma system.
RCT Entities:
BACKGROUND: Although in the developed world the intracranial pressure (ICP) monitor is considered the standard of care for patients with severe traumatic brain injury (TBI), its usefulness to direct treatment decisions has never been tested rigorously. OBJECTIVE: The primary focus was to conduct a high-quality, randomized, controlled trial to determine whether ICP monitoring used to direct TBI treatment improves patient outcomes. By providing education, equipment, and structure, the project will enhance the research capacity of the collaborating investigators and will foster the collaborations established during earlier studies. METHODS: Study centers were selected that routinely treated ICP based on clinical examination and computed tomography imaging using internal protocols. We randomized patients to either an ICP monitor group or an imaging and clinical examination group. Treatment decisions for the ICP monitor group are guided by ICP monitoring based on established guidelines. Treatment decisions for the imaging and clinical examination group are made using a single protocol derived from those previously being used at those centers. EXPECTED OUTCOMES: There are 2 study hypotheses: (1) patients with severe TBI whose acute care treatment is managed using ICP monitors will have improved outcomes and 2) incorporating ICP monitoring in the care of patients with severe TBI will minimize complications and decrease length of intensive care unit stay. DISCUSSION: This clinical trial tests the effectiveness of a management protocol based on technology considered pivotal to brain trauma treatment in the developed world: the ICP monitor. A randomized, controlled trial of ICP monitoring has never been performed-a critical gap in the evidence base that supports the role of ICP monitoring in TBI care. As such, the results of this randomized, controlled trial will have global implications regardless of the level of development of the trauma system.
Authors: M Maj; L D'Elia; P Satz; R Janssen; M Zaudig; C Uchiyama; F Starace; S Galderisi; A Chervinsky Journal: Arch Clin Neuropsychol Date: 1993-03 Impact factor: 2.813
Authors: M Cherner; P Suarez; D Lazzaretto; L Artiola I Fortuny; Monica Rivera Mindt; S Dawes; Thomas Marcotte; I Grant; R Heaton Journal: Arch Clin Neuropsychol Date: 2007-02-12 Impact factor: 2.813
Authors: Susan L Bratton; Randall M Chestnut; Jamshid Ghajar; Flora F McConnell Hammond; Odette A Harris; Roger Hartl; Geoffrey T Manley; Andrew Nemecek; David W Newell; Guy Rosenthal; Joost Schouten; Lori Shutter; Shelly D Timmons; Jamie S Ullman; Walter Videtta; Jack E Wilberger; David W Wright Journal: J Neurotrauma Date: 2007 Impact factor: 5.269
Authors: Steven Paul Woods; J Cobb Scott; Danielle A Sires; Igor Grant; Robert K Heaton; Alexander I Tröster Journal: J Int Neuropsychol Soc Date: 2005-07 Impact factor: 2.892
Authors: Luis Rafael Moscote-Salazar; Andres M Rubiano; Hernando Raphael Alvis-Miranda; Willem Calderon-Miranda; Gabriel Alcala-Cerra; Marco Antonio Blancas Rivera; Amit Agrawal Journal: Bull Emerg Trauma Date: 2016-01
Authors: Nancy A Carney; Gustavo J Petroni; Silvia B Luján; Nicolás M Ballarini; Gabriela A Faguaga; Hugo E M du Coudray; Amy E Huddleston; Gloria M Baggio; Juan M Becerra; Leonardo O Busso; Sureyya S Dikmen; Roberto Falcone; Mirta E García; Osvaldo R González Carrillo; Paula L Medici; Marta B Quaglino; Carina A Randisi; Silvia S Sáenz; Nancy R Temkin; Elida E Vanella Journal: Pediatr Crit Care Med Date: 2016-07 Impact factor: 3.624
Authors: Aziz S Alali; Robert A Fowler; Todd G Mainprize; Damon C Scales; Alexander Kiss; Charles de Mestral; Joel G Ray; Avery B Nathens Journal: J Neurotrauma Date: 2013-07-11 Impact factor: 5.269
Authors: Gisele Sampaio Silva; Nelson J Maldonado; Jorge H Mejia-Mantilla; Santiago Ortega-Gutierrez; Jan Claassen; Panayiotis Varelas; Jose I Suarez Journal: Neurocrit Care Date: 2019-12 Impact factor: 3.210