An observational study in Traumatic Brain Injury, sponsored by University of Cincinnati. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-25.
Sponsored by University of Cincinnati · Observational
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.
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 14 is below the median of 100 across 690 observational studies indexed under Brain Injuries.
Browse Brain Injuries studies →University of Cincinnati is the lead sponsor of 314 studies on the registry; 43 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 15 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with traumatic brain injury
Exclusion Criteria:
Traumatically brain injured patients undergoing in-hospital transport.
Incidence of adverse events during transport.
Time frame: Each transport event
Incidence of elevated heart rate during transport.
Time frame: Each transport event
Incidence of transport events during which SpO2 remains below 90% for 1 minute or longer
Time frame: Each transport event
Transport events during which systolic blood pressure remains below 90 mmHg for 5 minutes or longer
Time frame: Each transport event
Transport events during which mean arterial blood pressure remains below 60 mmHg for 5 minutes or longer
Time frame: Each transport event
Transport events during which intracranial pressure exceeds 20 mmHg for 5 minutes or longer
Time frame: Each transport event
Transport events during which cerebral perfusion pressure remains below 70 mmHg for 5 minutes or longer
Time frame: Each transport event
Number of instances of physiological change that require caregiver intervention, such as ventilator manipulation or drug therapy
Time frame: Each transport event
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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