Study of Eye Pressure as a Predictor of Intracranial Pressure in the Acutely Head-Injured Population
|ClinicalTrials.gov Identifier: NCT00534157|
Recruitment Status : Completed
First Posted : September 24, 2007
Last Update Posted : September 24, 2007
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||37 participants|
|Observational Model:||Defined Population|
|Official Title:||Intraocular Pressure as a Predictor of Intracranial Pressure in the Acutely Head-Injured Population|
|Study Start Date :||June 2004|
|Actual Study Completion Date :||April 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534157
|United States, Ohio|
|The Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Brian C Hiestand, MD||The Ohio State University Department of Emergency Medicine|