Effects of Transport on Patients With Traumatic Brain Injury

NCT ID: NCT01077089

Last Updated: 2013-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Traumatic Brain Injury

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Transported TBI patients

Traumatically brain injured patients undergoing in-hospital transport.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Rich Branson, M.D.

Professor of Clinical-Geo

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Warren A Dorlac, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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University Hospital

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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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. doi: 10.1097/00005373-199302000-00006.

Reference Type BACKGROUND
PMID: 8459458 (View on PubMed)

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. doi: 10.1007/978-3-7091-9302-0_21.

Reference Type BACKGROUND
PMID: 8310858 (View on PubMed)

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. doi: 10.1097/01.TA.0000037876.37236.D6.

Reference Type BACKGROUND
PMID: 12579057 (View on PubMed)

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. doi: 10.1001/archsurg.136.10.1118.

Reference Type BACKGROUND
PMID: 11585502 (View on PubMed)

Other Identifiers

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Dorlac-2010-01

Identifier Type: -

Identifier Source: org_study_id

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