Effects of Transport on Patients With Traumatic Brain Injury

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Study Design

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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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Transported TBI patients; Traumatically brain injured patients undergoing in-hospital transport.

Outcome Measures

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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 ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	February 26, 2010
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:

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