The Use of Tissue Oxygen Monitoring in Critically Injured Patients
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|ClinicalTrials.gov Identifier: NCT00328341|
Recruitment Status : Terminated (Slow to enroll.)
First Posted : May 19, 2006
Last Update Posted : September 19, 2013
|Condition or disease|
|Traumatic Brain Injury Hemorrhagic Shock Trauma|
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).
|Study Type :||Observational|
|Actual Enrollment :||67 participants|
|Official Title:||The Use of Tissue Oxygen Monitoring in Critically Injured Patients|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||December 2011|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00328341
|United States, California|
|University of California San Francisco, San Francisco General Hospital|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Geoffrey T Manley, MD, PhD||University of California, San Francisco|