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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by McMaster University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Niv Sne, McMaster University
ClinicalTrials.gov Identifier:
NCT00783809
First received: October 31, 2008
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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
Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of Optic Nerve Sheath in Traumatic Raised Intracranial Pressure

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Elevation in intracranial pressure as estimated by CT scan or ICP monitor [ Time Frame: Immediate ] [ Designated as safety issue: No ]

Estimated Enrollment: 560
Study Start Date: October 2008
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783809

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

No publications provided

Responsible Party: Niv Sne, Director of Trauma Research, McMaster University
ClinicalTrials.gov Identifier: NCT00783809     History of Changes
Other Study ID Numbers: PSI-34-2008
Study First Received: October 31, 2008
Last Updated: April 26, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
intracranial pressure
intracranial hypertension
ultrasound
emergency
traumatic brain injury
ocular ultrasound

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

ClinicalTrials.gov processed this record on November 25, 2014