Effects of Transport on Patients With Traumatic Brain Injury

Completed

• Conditions: Traumatic Brain Injury

• Registration Number: NCT01077089
• Lead Sponsor: University of Cincinnati

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-02-26
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-22
• Last Update Posted: 2013-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events during transport.	Each transport event

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital; 🇺🇸 Cincinnati, Ohio, United States