Effects of Transport on Patients With Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Effects of Transport on Patients With Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01077089
• Other study ID #: Dorlac-2010-01
• Status: Completed
• Phase: N/A
• First received: February 25, 2010
• Last updated: February 22, 2013
• Start date: February 2010
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Locations

Country	Name	City	State
United States	University Hospital	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events during transport.		Each transport event	Yes
Secondary	Incidence of elevated heart rate during transport.		Each transport event	Yes
Secondary	Incidence of transport events during which SpO2 remains below 90% for 1 minute or longer		Each transport event	Yes
Secondary	Transport events during which systolic blood pressure remains below 90 mmHg for 5 minutes or longer		Each transport event	Yes
Secondary	Transport events during which mean arterial blood pressure remains below 60 mmHg for 5 minutes or longer		Each transport event	Yes
Secondary	Transport events during which intracranial pressure exceeds 20 mmHg for 5 minutes or longer		Each transport event	Yes
Secondary	Transport events during which cerebral perfusion pressure remains below 70 mmHg for 5 minutes or longer		Each transport event	Yes
Secondary	Number of instances of physiological change that require caregiver intervention, such as ventilator manipulation or drug therapy		Each transport event	Yes