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Effects of Transport on Patients With Traumatic Brain Injury

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: NCT01077089
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : February 25, 2013
United States Department of Defense
Information provided by (Responsible Party):
Rich Branson, M.D., University of Cincinnati

Brief Summary:
Hospitalized patients are often moved from their rooms to other hospital locations, particularly imaging facilities. For patients with traumatic brain injury, such movements may raise the risk of secondary brain injuries. The purpose of this study is to monitor brain injured patients during transport and to measure the resulting changes in intracranial pressure. This will allow for documentation of the frequency of secondary injury and help in understanding their causes.

Condition or disease
Traumatic Brain Injury

Detailed Description:
Secondary insults, such as hypoxia and hypotension, may worsen a brain injury. We hypothesize that secondary brain insults may occur frequently during in-hospital transport in patients with traumatic brain injury (TBI). We additionally hypothesize that automated data collection devices used during transport could more reliably document the frequency of these events and help us to understand the causes. During transport of patients with TBI, intracranial pressure and arterial blood pressure will be continuously recorded to a monitor and saved for later analysis. Additional continuous measurements of pulse oximetry, end-tidal carbon dioxide, and mechanical ventilation settings will be made. The study will identify patients at risk for secondary insults, the etiology of these insults, and assist in development of a road map to prevent future incidents.

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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Effects of Transport on Patients With Traumatic Brain Injury
Study Start Date : February 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Transported TBI patients
Traumatically brain injured patients undergoing in-hospital transport.

Primary Outcome Measures :
  1. Incidence of adverse events during transport. [ Time Frame: Each transport event ]

Secondary Outcome Measures :
  1. Incidence of elevated heart rate during transport. [ Time Frame: Each transport event ]
  2. Incidence of transport events during which SpO2 remains below 90% for 1 minute or longer [ Time Frame: Each transport event ]
  3. Transport events during which systolic blood pressure remains below 90 mmHg for 5 minutes or longer [ Time Frame: Each transport event ]
  4. Transport events during which mean arterial blood pressure remains below 60 mmHg for 5 minutes or longer [ Time Frame: Each transport event ]
  5. Transport events during which intracranial pressure exceeds 20 mmHg for 5 minutes or longer [ Time Frame: Each transport event ]
  6. Transport events during which cerebral perfusion pressure remains below 70 mmHg for 5 minutes or longer [ Time Frame: Each transport event ]
  7. Number of instances of physiological change that require caregiver intervention, such as ventilator manipulation or drug therapy [ Time Frame: Each transport event ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with traumatic brain injury

Inclusion Criteria:

  • presence of traumatic brain injury and intracranial pressure monitoring
  • requiring mechanical ventilation
  • presence of an indwelling arterial catheter for monitoring blood pressure
  • Age of at least 18 years

Exclusion Criteria:

  • Age less than 18 years
  • diagnosis of brain death
  • non-English speakers
  • prisoners
  • mentally ill persons

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): NCT01077089

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United States, Ohio
University Hospital
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
United States Department of Defense
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Principal Investigator: Warren A Dorlac, MD University of Cincinnati
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Responsible Party: Rich Branson, M.D., Professor of Clinical-Geo, University of Cincinnati Identifier: NCT01077089    
Other Study ID Numbers: Dorlac-2010-01
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: February 25, 2013
Last Verified: February 2013
Keywords provided by Rich Branson, M.D., University of Cincinnati:
traumatic brain injury
In-hospital transport
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System