Traumatic Brain InjuryNCT00328341
The Use of Tissue Oxygen Monitoring in Critically Injured Patients
An observational study of Traumatic Brain Injury and Hemorrhagic Shock, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Hemorrhagic Shock, Trauma
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Age less than 18 years
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco, San Francisco General Hospital
San Francisco, California, 94110
About this study
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.
Read the 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).
- Conditions
- Traumatic Brain Injury, Hemorrhagic Shock, Trauma
- Keywords
- traumatic brain injury, hemorrhagic shock, multisystem trauma, under resuscitation, tissue oxygen monitoring
- Medical subject headings
- Brain Injuries, Traumatic, Shock, Hemorrhagic, Wounds and Injuries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startApr 2006
- Primary completionApr 2009
- Study completionDec 2011
Why it stopped: Slow to enroll.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Geoffrey T Manley, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328341
- Sponsor's protocol ID
- H6693-19472-05
- Status last verified
- Sep 2013
- First submitted
- 17 May 2006
- Last updated
- 19 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Tissue Oxygen Monitoring in Critically Injured Patients
- ClinicalTrials.gov ID
- NCT00328341
- Acronym / sponsor ID
- H6693-19472-05
- Conditions
- Traumatic Brain Injury, Hemorrhagic Shock, Trauma
- Keywords
- traumatic brain injury, hemorrhagic shock, multisystem trauma, under resuscitation, tissue oxygen monitoring
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow to enroll.
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Apr 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Age less than 18 years
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Slow to enroll.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffrey T Manley, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Hemorrhagic Shock, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow to enroll.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2013.