NCT00534157

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2007

Completed
Last Updated

September 24, 2007

Status Verified

March 1, 2007

First QC Date

September 21, 2007

Last Update Submit

September 21, 2007

Conditions

Keywords

intracranial pressureintraocular pressuretonometry

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and Injuries

Study Officials

  • Brian C Hiestand, MD

    The Ohio State University Department of Emergency Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 21, 2007

First Posted

September 24, 2007

Study Start

June 1, 2004

Study Completion

April 1, 2007

Last Updated

September 24, 2007

Record last verified: 2007-03

Locations