Effects of Transport on Patients With Traumatic Brain Injury - Full Text View

Purpose

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
Traumatic Brain Injury


Study Type:	Observational
Study Design:	Observational Model: Ecologic or Community Time Perspective: Prospective
Official Title:	Effects of Transport on Patients With Traumatic Brain Injury

Resource links provided by NLM:

MedlinePlus related topics: Health Facilities Traumatic Brain Injury

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:

Incidence of adverse events during transport. [ Time Frame: Each transport event ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]


Enrollment:	14
Study Start Date:	February 2010
Study Completion Date:	October 2012
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

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

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with traumatic brain injury

Criteria

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

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: NCT01077089

Locations


United States, Ohio
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

More Information

Publications:

Chesnut RM, Marshall LF, Klauber MR, Blunt BA, Baldwin N, Eisenberg HM, Jane JA, Marmarou A, Foulkes MA. The role of secondary brain injury in determining outcome from severe head injury. J Trauma. 1993 Feb;34(2):216-22.

Chesnut RM, Marshall SB, Piek J, Blunt BA, Klauber MR, Marshall LF. Early and late systemic hypotension as a frequent and fundamental source of cerebral ischemia following severe brain injury in the Traumatic Coma Data Bank. Acta Neurochir Suppl (Wien). 1993;59:121-5.

Jeremitsky E, Omert L, Dunham CM, Protetch J, Rodriguez A. Harbingers of poor outcome the day after severe brain injury: hypothermia, hypoxia, and hypoperfusion. J Trauma. 2003 Feb;54(2):312-9.

Manley G, Knudson MM, Morabito D, Damron S, Erickson V, Pitts L. Hypotension, hypoxia, and head injury: frequency, duration, and consequences. Arch Surg. 2001 Oct;136(10):1118-23.


Responsible Party:	Rich Branson, M.D., Professor of Clinical-Geo, University of Cincinnati
ClinicalTrials.gov Identifier:	NCT01077089 History of Changes
Other Study ID Numbers:	Dorlac-2010-01
Study First Received:	February 25, 2010
Last Updated:	February 22, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Cincinnati:


traumatic brain injury In-hospital transport

Additional relevant MeSH terms:


Wounds and Injuries Brain Injuries Brain Diseases Central Nervous System Diseases	Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System

ClinicalTrials.gov processed this record on September 26, 2016