Clinical trial NCT01077089: Effects of Transport on Patients With Traumatic Brain Injury
Official title: Effects of Transport on Patients With Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury
In-hospital transport
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2010-02-26
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with traumatic brain injury

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.

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 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

Primary outcomes:
measure: Incidence of adverse events during transport.
timeFrame: Each transport event
Secondary outcomes:
measure: Incidence of elevated heart rate during transport.
timeFrame: Each transport event
measure: Incidence of transport events during which SpO2 remains below 90% for 1 minute or longer
timeFrame: Each transport event
measure: Transport events during which systolic blood pressure remains below 90 mmHg for 5 minutes or longer
timeFrame: Each transport event
measure: Transport events during which mean arterial blood pressure remains below 60 mmHg for 5 minutes or longer
timeFrame: Each transport event
measure: Transport events during which intracranial pressure exceeds 20 mmHg for 5 minutes or longer
timeFrame: Each transport event
measure: Transport events during which cerebral perfusion pressure remains below 70 mmHg for 5 minutes or longer
timeFrame: Each transport event
measure: Number of instances of physiological change that require caregiver intervention, such as ventilator manipulation or drug therapy
timeFrame: Each transport event
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University Hospital
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Warren A Dorlac, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.