Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328341
Status:
TERMINATED
Last Update Posted:
2013-09-19
First Post:
2006-05-17
Brief Title:
The Use of Tissue Oxygen Monitoring in Critically Injured Patients
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
The Use of Tissue Oxygen Monitoring in Critically Injured Patients
Status:
TERMINATED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow to enroll
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None