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Study of Eye Pressure as a Predictor of Intracranial Pressure in the Acutely Head-Injured Population

21 de septiembre de 2007 actualizado por: Ohio State University

Intraocular Pressure as a Predictor of Intracranial Pressure in the Acutely Head-Injured Population

The purpose of this study is to determine if the pressure in the eye of a severely head-injured person correlates with the pressure in the person's skull. This is a prospective study of patients aged 18 and older who have experienced a traumatic closed head injury and are intubated either before or during the time they are in the Emergency Department (ED). Identified patients have an eye pressure measurement performed in the trauma bay by an OSU ED physician not involved in their care. Information about their hospital stay, including the first brain pressure measurement if a such a measuring device is used, will be collected. In addition, the outcome of their hospital stay will be recorded.

Descripción general del estudio

Estado

Terminado

Descripción detallada

Traumatic brain injury (TBI) is a leading cause of morbidity and mortality in the United States, with an estimated 1.5 million American sustaining a TBI and 50,000 people dying from a TBI each year. While the immediate, or primary, injury causes significant damage, secondary injury is caused by cerebral edema, increased intracranial pressure, and resultant hypoperfusion and ischemia. Elevated intracranial pressure is strongly associated with poor recovery and death; failure to control intracranial pressure is likewise associated with poor outcomes and mortality.

Early detection of elevated ICP allows for the initiation of early therapy. However, patients with significant head injuries are often intubated for airway protection. The sedation required for intubation obscures the ED neurologic exam. Precise measurement of elevated ICP has required invasive monitoring via ventriculostomy. Yet this method is only provided at set institutions with neurosurgical services. Further there are distinct time delays between the trauma occurrence, transportation to a facility with neurosurgical services and placement of ventriculostomies. There is at the forefront, then, to establish non-invasive measures of ICP that are both time efficient and reliable.

Previous studies, including a pilot study conducted at this institution, showed a correlation between intraocular and intracranial pressure. However, this relationship has not been tested in an acute care trauma setting. We propose an observational cohort study of critically injured trauma patients with suspected closed head injury. Patients requiring intubation and mechanical ventilation pose a significant challenge to assess neurologically, as they are almost always sedated and often chemically paralyzed to facilitate airway management. Therefore, it is in this population of intubated trauma patients with suspected head injury that we will evaluate the use of tonometry to predict intracranial pressure from intraocular pressure.

Tipo de estudio

De observación

Inscripción (Actual)

37

Contactos y Ubicaciones

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Ubicaciones de estudio

    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210
        • The Ohio State University Medical Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patients with suspected acute traumatic head injury
  • Intubated prior to arrival in the Emergency Department or in the Emergency Department, including patients transferred from other facilities

Exclusion Criteria:

  • Too unstable to allow the investigator access to the head of the bed to perform tonometry.
  • Severe ocular or facial trauma such that an intact globe is not accessible
  • Known history of glaucoma
  • Penetrating head injury
  • Patients that undergo operative decompression prior to the placement of an intracranial pressure monitor may be screened in the trauma bay and have an intraocular pressure obtained; however, these patients will not be included in the intraocular / intracranial pressure analysis.
  • Known allergy to latex or tetracaine

Plan de estudios

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¿Cómo está diseñado el estudio?

Detalles de diseño

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Brian C Hiestand, MD, The Ohio State University Department of Emergency Medicine

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de junio de 2004

Finalización del estudio (Actual)

1 de abril de 2007

Fechas de registro del estudio

Enviado por primera vez

21 de septiembre de 2007

Primero enviado que cumplió con los criterios de control de calidad

21 de septiembre de 2007

Publicado por primera vez (Estimar)

24 de septiembre de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

24 de septiembre de 2007

Última actualización enviada que cumplió con los criterios de control de calidad

21 de septiembre de 2007

Última verificación

1 de marzo de 2007

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2004H0126

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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