Hypoxia-Ischemia, BrainDOSINCT01483495
Assessing Cerebrovascular Reactivity Based on Cerebral Oximetry: a Pilot Study
An observational study of Hypoxia-Ischemia, Brain and Signs and Symptoms, run by University of California, Irvine at 1 site in United States.
Trial summary
The brain is such a metabolically active organ that it consumes about 20% of oxygen burned every minute by an average adult even though it only contributes about 2% of the body weight. As a result, the brain produces a disproportionately high amount of CO2 every minute in comparison with the rest of the body. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypoxia-Ischemia, Brain, Signs and Symptoms
- What is being tested?
- Diffuse optical spectroscopy
- Type of treatment
- Medical device
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elective surgery
Who may be able to join
- Male or Female 20 years of age and older
- Female non-pregnant
- Subject scheduled for elective surgery under general anesthesia with intubation.
- Subject who is able to give informed consent.
Who cannot join
- Less than 20 years old of age
- Pregnant woman
- Subjects currently diagnosed with severe hypertension, myocardial ischemic disease, symptomatic valvular disease(s), symptomatic arrhythmia, uncompensated congestive heart failure, intracranial aneurysm.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCI Beckman Laser Institute
Irvine, California, 92612
About this study
Official title: Assessing Cerebrovascular Reactivity Based on Cerebral Oximetry
The brain is such a metabolically active organ that it consumes about 20% of oxygen burned every minute by an average adult even though it only contributes about 2% of the body weight. As a result, the brain produces a disproportionately high amount of CO2 every minute in comparison with the rest of the body.
Read the detailed description
The researcher can use Diffuse Optical Spectroscopy Imaging, cerebral non-invasive oximetry instrument, to determine cerebrovascular reactivity during surgery procedure. Specifically, the cerebral tissue O2 saturation can measure by Diffuse Optical Spectroscopy Imaging can use for cerebral blood flow in the evaluation of cerebrovascular reactivity.
Adequate brain perfusion is critical not only to supply oxygen and nutrients but also to wash out metabolic end products including CO2. Blood flow depends on perfusion pressure and vascular bed resistance. It is well known that multiple physiological and pathological factors affect cerebral vasculature, and the resistance to blood flow. The cerebrovascular responsiveness to those factors determines how well the brain can maintain and adjust its perfusion.
- Conditions
- Hypoxia-Ischemia, Brain, Signs and Symptoms
- Being tested
- Diffuse optical spectroscopy
- Medical subject headings
- Hypoxia-Ischemia, Brain, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffuse optical spectroscopyDevice
Also called Diffuse Optical Spectroscopy Imaging
Diffuse Optical Spectroscopy Imaging Cerebrovascular Reactivity
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic tool | Diffuse Optical Spectroscopy Imaging Cerebrovascular Reactivity Receives: Device: Diffuse optical spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain blood flow
Optical Imaging assess of Brain blood flow during surgical procedure
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxia-Ischemia, BrainStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Bruce Tromberg, PhD, Study director, Beckman Laser InstituteLingzhong Meng, M.D, Principal investigator, Anesthesiology Perioperative Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483495
- Sponsor's protocol ID
- 20107521
- Acronym
- DOSI
- Status last verified
- Oct 2022
- First submitted
- 2 Aug 2011
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Cerebrovascular Reactivity Based on Cerebral Oximetry
- ClinicalTrials.gov ID
- NCT01483495
- Acronym / sponsor ID
- DOSI / 20107521
- Conditions
- Hypoxia-Ischemia, Brain, Signs and Symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Dec 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 1 Dec 2011 (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.
The brain is such a metabolically active organ that it consumes about 20% of oxygen burned every minute by an average adult even though it only contributes about 2% of the body weight. As a result, the brain produces a disproportionately high amount of CO2 every minute in comparison with the rest of the body.
Detailed description
The researcher can use Diffuse Optical Spectroscopy Imaging, cerebral non-invasive oximetry instrument, to determine cerebrovascular reactivity during surgery procedure. Specifically, the cerebral tissue O2 saturation can measure by Diffuse Optical Spectroscopy Imaging can use for cerebral blood flow in the evaluation of cerebrovascular reactivity.
Adequate brain perfusion is critical not only to supply oxygen and nutrients but also to wash out metabolic end products including CO2. Blood flow depends on perfusion pressure and vascular bed resistance. It is well known that multiple physiological and pathological factors affect cerebral vasculature, and the resistance to blood flow. The cerebrovascular responsiveness to those factors determines how well the brain can maintain and adjust its perfusion.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic tool | – | Device: Diffuse optical spectroscopyDiffuse Optical Spectroscopy Imaging Cerebrovascular Reactivity |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elective surgery
Key inclusion criteria (4 listed)
- Male or Female 20 years of age and older
- Female non-pregnant
- Subject scheduled for elective surgery under general anesthesia with intubation.
- Subject who is able to give informed consent.
Key exclusion criteria (3 listed)
- Less than 20 years old of age
- Pregnant woman
- Subjects currently diagnosed with severe hypertension, myocardial ischemic disease, symptomatic valvular disease(s), symptomatic arrhythmia, uncompensated congestive heart failure, intracranial aneurysm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffuse optical spectroscopyAlso: Diffuse Optical Spectroscopy ImagingDiffuse Optical Spectroscopy Imaging Cerebrovascular Reactivity | Device | Diagnostic tool |
Primary outcome
Brain blood flow
Time frame: 6 hours
Optical Imaging assess of Brain blood flow during surgical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
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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.
Bruce Tromberg, PhD study director
Beckman Laser Institute
Lingzhong Meng, M.D principal investigator
Anesthesiology Perioperative Care
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 Hypoxia-Ischemia, Brain and Signs and Symptoms, run by University of California, Irvine 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 3 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: finished, as of the sponsor's last update on 1 Nov 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Brain blood flow (time frame: 6 hours). It is what the study was designed to measure, not a finding.
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 1 Nov 2022; AzTrials last refreshed its copy on 1 Nov 2026.