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OpenTrials
Completed

NCT Number: NCT01077089

Effects of Transport on Patients With Traumatic Brain Injury

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Cincinnati, Ohio, 45267, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of adverse events during transport.

    Time frame: Each transport event

Secondary outcomes

  1. Incidence of elevated heart rate during transport.

    Time frame: Each transport event

  2. Incidence of transport events during which SpO2 remains below 90% for 1 minute or longer

    Time frame: Each transport event

  3. Transport events during which systolic blood pressure remains below 90 mmHg for 5 minutes or longer

    Time frame: Each transport event

  4. Transport events during which mean arterial blood pressure remains below 60 mmHg for 5 minutes or longer

    Time frame: Each transport event

  5. Transport events during which intracranial pressure exceeds 20 mmHg for 5 minutes or longer

    Time frame: Each transport event

  6. Transport events during which cerebral perfusion pressure remains below 70 mmHg for 5 minutes or longer

    Time frame: Each transport event

  7. Number of instances of physiological change that require caregiver intervention, such as ventilator manipulation or drug therapy

    Time frame: Each transport event

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 26, 2010
Registry last updated
Feb 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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