The Use of Tissue Oxygen Monitoring in Critically Injured Patients

This study has been terminated.
(Slow to enroll.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00328341
First received: May 17, 2006
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

It is anticipated that the use of tissue oxygen monitoring to measure brain tissue oxygen and deltoid muscle oxygen will provide more precise information about focal brain ischemia and systemic hypoperfusion than current techniques and measures such as blood pressure, heart rate and intracranial pressure. Understanding the relationship between tissue oxygen tension collected from the brain and deltoid muscle in critically injured patients could lead to a broader understanding of the important metabolic and cellular events that occur following severe injury and the changes induced by therapeutic interventions. Furthermore, the use of interventions designed to improve tissue hypoxia, as measured by low brain or muscle tissue oxygen, may improve mortality or neurological recovery after systemic trauma or head trauma compared to current approaches that do not involve tissue metabolic monitoring.


Condition
Traumatic Brain Injury
Hemorrhagic Shock
Trauma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of Tissue Oxygen Monitoring in Critically Injured Patients

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Enrollment: 67
Study Start Date: April 2006
Study Completion Date: December 2011
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Detailed Description:

This is a prospective, observational, cohort study designed to investigate metabolic changes in the brain and deltoid muscle of injured patients. Study objectives are as follows:

  • To establish critical, abnormal levels of tissue oxygen in the brain (PbrO2) and muscle (PmO2) of injured patients.
  • To correlate PbrO2 with other currently available diagnostic measures used in head-injured patients, including ICP, mean arterial blood pressure (MAP), CPP, SjO2, CT findings, neurological examinations, and clinical outcomes from traumatic brain injury.
  • To correlate PmO2 with base deficit measurements, standard physiologic variables, near infra-red oxygen levels, infectious complications, and outcomes in critically injured patients.

Investigators will enroll patients with multisystem trauma including brain injury. In addition to the results obtained from oxygen monitoring, other data collected prospectively will include:

  1. Baseline Characteristics- mechanism of injury, arrival blood pressure and GCS, results of imaging procedures, age, gender, blood gas analysis, injuries and injury severity, and all operative procedures,
  2. ICU Care - MAP, ICP, CPP, base deficit, oxygen saturation, CVP, cardiac output, GCS scores, short-term outcome data, infectious complications and organ dysfunction.

All physiological data will be downloaded automatically and continuously from the bedside monitor, ventilator, and oxygen monitors via a study-dedicated computer and customized software (Aristein Bioinformatics, Palo Alto, CA).

  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

Inclusion Criteria:

  • Age 18 years and older
  • Intubated and assisted mechanical ventilation
  • Traumatic brain injury requiring advanced neuromonitoring
  • Abbreviated injury scale 3 or more in torso. abdomen, or extremities
Criteria

Inclusion Criteria:

  • Age 18 years and older
  • Intubated and assisted mechanical ventilation
  • Traumatic brain injury requiring advanced neuromonitoring
  • Abbreviated injury scale 3 or more in torso. abdomen, or extremities

Exclusion Criteria:

  • Age less than 18 years
  • Pregnancy
  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: NCT00328341

Locations
United States, California
University of California San Francisco, San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Geoffrey T Manley, MD, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00328341     History of Changes
Other Study ID Numbers: H6693-19472-05
Study First Received: May 17, 2006
Last Updated: September 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
traumatic brain injury
hemorrhagic shock
multisystem trauma
under resuscitation
tissue oxygen monitoring

Additional relevant MeSH terms:
Brain Injuries
Shock, Hemorrhagic
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Hemorrhage
Nervous System Diseases
Pathologic Processes
Shock
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014