This trial is active, not recruiting.

Condition traumatic brain injury
Sponsor McMaster University
Collaborator The Physicians' Services Incorporated Foundation
Start date October 2008
End date August 2012
Trial size 560 participants
Trial identifier NCT00783809, PSI-34-2008


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Elevation in intracranial pressure as estimated by CT scan or ICP monitor
time frame: Immediate

Eligibility Criteria

Male or female participants at least 16 years old.

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

Additional Information

Official title Measurement of Optic Nerve Sheath in Traumatic Raised Intracranial Pressure
Principal investigator Niv Sne, MD FRCSC
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by McMaster University.