Effects of Transport on Patients With Traumatic Brain Injury

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rich Branson, M.D., University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01077089
First received: February 25, 2010
Last updated: February 22, 2013
Last verified: February 2013

February 25, 2010
February 22, 2013
February 2010
October 2012   (final data collection date for primary outcome measure)
Incidence of adverse events during transport. [ Time Frame: Each transport event ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01077089 on ClinicalTrials.gov Archive Site
  • Incidence of elevated heart rate during transport. [ Time Frame: Each transport event ] [ Designated as safety issue: Yes ]
  • Incidence of transport events during which SpO2 remains below 90% for 1 minute or longer [ Time Frame: Each transport event ] [ Designated as safety issue: Yes ]
  • Transport events during which systolic blood pressure remains below 90 mmHg for 5 minutes or longer [ Time Frame: Each transport event ] [ Designated as safety issue: Yes ]
  • Transport events during which mean arterial blood pressure remains below 60 mmHg for 5 minutes or longer [ Time Frame: Each transport event ] [ Designated as safety issue: Yes ]
  • Transport events during which intracranial pressure exceeds 20 mmHg for 5 minutes or longer [ Time Frame: Each transport event ] [ Designated as safety issue: Yes ]
  • Transport events during which cerebral perfusion pressure remains below 70 mmHg for 5 minutes or longer [ Time Frame: Each transport event ] [ Designated as safety issue: Yes ]
  • Number of instances of physiological change that require caregiver intervention, such as ventilator manipulation or drug therapy [ Time Frame: Each transport event ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Transport on Patients With Traumatic Brain Injury
Effects of Transport on Patients With Traumatic Brain Injury

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.

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.

Observational
Observational Model: Ecologic or Community
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with traumatic brain injury

Traumatic Brain Injury
Not Provided
Transported TBI patients
Traumatically brain injured patients undergoing in-hospital transport.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01077089
Dorlac-2010-01
No
Rich Branson, M.D., University of Cincinnati
University of Cincinnati
Department of Defense
Principal Investigator: Warren A Dorlac, MD University of Cincinnati
University of Cincinnati
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP