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Effects of Transport on Patients With Traumatic Brain Injury

This study has been completed.
Sponsor:
Collaborator:
Department of Defense
Information provided by (Responsible Party):
Rich Branson, M.D., University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01077089
First received: February 25, 2010
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition
Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Effects of Transport on Patients With Traumatic Brain Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Incidence of adverse events during transport. [ Time Frame: Each transport event ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of elevated heart rate during transport. [ Time Frame: Each transport event ] [ Designated as safety issue: Yes ]
  • Incidence of transport events during which SpO2 remains below 90% for 1 minute or longer [ Time Frame: Each transport event ] [ Designated as safety issue: Yes ]
  • Transport events during which systolic blood pressure remains below 90 mmHg for 5 minutes or longer [ Time Frame: Each transport event ] [ Designated as safety issue: Yes ]
  • Transport events during which mean arterial blood pressure remains below 60 mmHg for 5 minutes or longer [ Time Frame: Each transport event ] [ Designated as safety issue: Yes ]
  • Transport events during which intracranial pressure exceeds 20 mmHg for 5 minutes or longer [ Time Frame: Each transport event ] [ Designated as safety issue: Yes ]
  • Transport events during which cerebral perfusion pressure remains below 70 mmHg for 5 minutes or longer [ Time Frame: Each transport event ] [ Designated as safety issue: Yes ]
  • Number of instances of physiological change that require caregiver intervention, such as ventilator manipulation or drug therapy [ Time Frame: Each transport event ] [ Designated as safety issue: Yes ]
Enrollment: 14
Study Start Date: February 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Transported TBI patients
Traumatically brain injured patients undergoing in-hospital transport.

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with traumatic brain injury

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077089

Locations
United States, Ohio
University Hospital
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Department of Defense
Investigators
Principal Investigator: Warren A Dorlac, MD University of Cincinnati
  More Information

Publications:

Responsible Party: Rich Branson, M.D., Professor of Clinical-Geo, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01077089     History of Changes
Other Study ID Numbers: Dorlac-2010-01
Study First Received: February 25, 2010
Last Updated: February 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
traumatic brain injury
In-hospital transport

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on March 03, 2015