The Use of Tissue Oxygen Monitoring in Critically Injured Patients

NCT00328341 | Terminated

• 1 other identifier: H6693-19472-05
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury; Hemorrhagic Shock; Trauma

Keywords

traumatic brain injury; hemorrhagic shock; multisystem trauma; under resuscitation; tissue oxygen monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Age less than 18 years
• Pregnancy

Sponsors & Collaborators

• University of California, San Francisco: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

University of California San Francisco, San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Shock, Hemorrhagic; Wounds and Injuries

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Geoffrey T Manley, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2006
• First Posted: May 19, 2006
• Study Start: April 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: December 1, 2011
• Last Updated: September 19, 2013

Record last verified: 2013-09

Locations

US (1)