Skip to main content
Clinical Trials/NCT01077089
NCT01077089
Completed
Not Applicable

Effects of Transport on Patients With Traumatic Brain Injury

University of Cincinnati1 site in 1 country14 target enrollmentFebruary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
University of Cincinnati
Enrollment
14
Locations
1
Primary Endpoint
Incidence of adverse events during transport.
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
October 2012
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rich Branson, M.D.

Professor of Clinical-Geo

University of Cincinnati

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

Outcomes

Primary Outcomes

Incidence of adverse events during transport.

Time Frame: Each transport event

Secondary Outcomes

  • Incidence of elevated heart rate during transport.(Each transport event)
  • Incidence of transport events during which SpO2 remains below 90% for 1 minute or longer(Each transport event)
  • Transport events during which systolic blood pressure remains below 90 mmHg for 5 minutes or longer(Each transport event)
  • Transport events during which mean arterial blood pressure remains below 60 mmHg for 5 minutes or longer(Each transport event)
  • Transport events during which intracranial pressure exceeds 20 mmHg for 5 minutes or longer(Each transport event)
  • Transport events during which cerebral perfusion pressure remains below 70 mmHg for 5 minutes or longer(Each transport event)
  • Number of instances of physiological change that require caregiver intervention, such as ventilator manipulation or drug therapy(Each transport event)

Study Sites (1)

Loading locations...

Similar Trials