The Use of Tissue Oxygen Monitoring in Critically Injured Patients - Full Text View

Sponsors and Collaborators:	University of California, San Francisco Centers for Disease Control and Prevention
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00328341

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

MedlinePlus related topics: Injuries Traumatic Brain Injury Wounds

U.S. FDA Resources

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

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

Estimated Enrollment:	30
Study Start Date:	April 2006

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:

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,
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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328341

Contacts

Contact: Margaret Knudson, MD

415-206-4623

pknudson@sfghsurg.ucsf.edu

Locations

United States, California
University of California San Francisco, San Francisco General Hospital	Recruiting
San Francisco, California, United States, 94110

Sponsors and Collaborators

University of California, San Francisco

Centers for Disease Control and Prevention

Investigators

Principal Investigator:

Geoffrey T Manley, MD, PhD

University of California, San Francisco

More Information

Study ID Numbers:	H6693-19472-05
Study First Received:	May 17, 2006
Last Updated:	March 27, 2008
ClinicalTrials.gov Identifier:	NCT00328341
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

Study placed in the following topic categories:

Craniocerebral Trauma
Shock
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases

Trauma, Nervous System
Brain Diseases
Hemorrhage
Brain Injuries
Shock, Hemorrhagic

Additional relevant MeSH terms:

Pathologic Processes
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009