Measurement of Optic Nerve Sheath in Traumatic Raised Intracranial Pressure (MOONSTRIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00783809
Recruitment Status : Unknown
Verified April 2012 by Niv Sne, McMaster University.
Recruitment status was:  Active, not recruiting
First Posted : November 3, 2008
Last Update Posted : April 27, 2012
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Niv Sne, McMaster University

Brief Summary:

Trauma patients are at risk for serious head trauma. The consequences of serious head trauma are often life altering. Currently, the only method available to rapidly assess the severity of head injury and need for neurosurgical intervention is the CT scan. This time consuming test requires transportation of a potentially unstable patient to the CT scanner.

The investigators goal in traumatic brain injury is to identify early those patients who may require neurosurgical intervention. Brain swelling (elevated intracranial pressure) is transmitted to the eye and this can be measured with ultrasound. The investigators hypothesis is that this test will rule out significant elevations in intracranial pressure and perform as well as CT scan in doing this.

The investigators study aims to demonstrate that ultrasound of the optic nerve is as good as CT scan in ruling out clinically significant elevations in pressure within the brain. After consent has been obtained, any trauma patient who has an indication to undergo CT scan of the brain will also undergo ultrasound of the eye. A radiologist will then review the CT scans to determine if signs of elevated intracranial pressure are present. The investigators hope to demonstrate that a bedside ultrasound performed in the trauma suite is reliable for ruling out the possibility of elevated intracranial pressure.

**Update August 2009** Currently, deferred consent has been obtained from our REB allowing us to defer consent for this intervention of minimal risk. As well, REB has also approved phone consent in the interim.

Condition or disease
Traumatic Brain Injury

Study Type : Observational
Estimated Enrollment : 560 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of Optic Nerve Sheath in Traumatic Raised Intracranial Pressure
Study Start Date : October 2008
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2012

Primary Outcome Measures :
  1. Elevation in intracranial pressure as estimated by CT scan or ICP monitor [ Time Frame: Immediate ]

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who present to the emergency department with suspected closed head injury as a result of blunt trauma and require CT head

Inclusion Criteria:

  • Age greater or equal to 16 involved in blunt trauma.
  • Patient is to undergo a CT of the head to evaluate suspected closed head injury
  • Consent and ultrasound can be preformed within 1 hour before or after CT of the head

Exclusion Criteria:

  • Penetrating trauma to the head or significant ocular trauma
  • Patients not expected to survive transfer out of the emergency room department
  • Patient is too unstable to undergo a CT of the head or ultrasound of the optic nerve

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00783809

Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L2X2
Sponsors and Collaborators
McMaster University
The Physicians' Services Incorporated Foundation
Principal Investigator: Niv Sne, MD FRCSC Hamilton Health Sciences Corporation
Study Chair: Andrew J Healey, MD FRCPC Hamilton Health Sciences Corporation

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Niv Sne, Director of Trauma Research, McMaster University Identifier: NCT00783809     History of Changes
Other Study ID Numbers: PSI-34-2008
First Posted: November 3, 2008    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012

Keywords provided by Niv Sne, McMaster University:
intracranial pressure
intracranial hypertension
traumatic brain injury
ocular ultrasound

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries