Effects of Transport on Patients With Traumatic Brain Injury

Sponsor
University of Cincinnati (Other)
Overall Status
Completed
CT.gov ID
NCT01077089
Collaborator
United States Department of Defense (U.S. Fed)
14
1
32
0.4

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    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 :
    Feb 1, 2010
    Actual Primary Completion Date :
    Oct 1, 2012
    Actual Study Completion Date :
    Oct 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Transported TBI patients

    Traumatically brain injured patients undergoing in-hospital transport.

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events during transport. [Each transport event]

    Secondary Outcome Measures

    1. Incidence of elevated heart rate during transport. [Each transport event]

    2. Incidence of transport events during which SpO2 remains below 90% for 1 minute or longer [Each transport event]

    3. Transport events during which systolic blood pressure remains below 90 mmHg for 5 minutes or longer [Each transport event]

    4. Transport events during which mean arterial blood pressure remains below 60 mmHg for 5 minutes or longer [Each transport event]

    5. Transport events during which intracranial pressure exceeds 20 mmHg for 5 minutes or longer [Each transport event]

    6. Transport events during which cerebral perfusion pressure remains below 70 mmHg for 5 minutes or longer [Each transport event]

    7. Number of instances of physiological change that require caregiver intervention, such as ventilator manipulation or drug therapy [Each transport event]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Cincinnati Ohio United States 45267

    Sponsors and Collaborators

    • University of Cincinnati
    • United States Department of Defense

    Investigators

    • Principal Investigator: Warren A Dorlac, MD, University of Cincinnati

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Rich Branson, M.D., Professor of Clinical-Geo, University of Cincinnati
    ClinicalTrials.gov Identifier:
    NCT01077089
    Other Study ID Numbers:
    • Dorlac-2010-01
    First Posted:
    Feb 26, 2010
    Last Update Posted:
    Feb 25, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by Rich Branson, M.D., Professor of Clinical-Geo, University of Cincinnati
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 25, 2013