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Assessing Cerebrovascular Reactivity Based on Cerebral Oximetry: a Pilot Study (DOSI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01483495
First Posted: December 1, 2011
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
  Purpose
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.

Condition Intervention
Hypoxia-Ischemia, Brain Signs and Symptoms Device: Diffuse optical spectroscopy

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Assessing Cerebrovascular Reactivity Based on Cerebral Oximetry

Further study details as provided by Beckman Laser Institute and Medical Center, University of California, Irvine:

Primary Outcome Measures:
  • Brain blood flow [ Time Frame: 6 hours ]
    Optical Imaging assess of Brain blood flow during surgical procedure


Enrollment: 78
Study Start Date: December 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Diagnostic tool
Diffuse Optical Spectroscopy Imaging Cerebrovascular Reactivity
Device: Diffuse optical spectroscopy
Diffuse Optical Spectroscopy Imaging Cerebrovascular Reactivity
Other Name: Diffuse Optical Spectroscopy Imaging

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Elective surgery
Criteria

Inclusion Criteria:

  1. Male or Female 20 years of age and older
  2. Female non-pregnant
  3. Subject scheduled for elective surgery under general anesthesia with intubation.
  4. Subject who is able to give informed consent.

Exclusion Criteria:

  1. Less than 20 years old of age
  2. Pregnant woman
  3. Subjects currently diagnosed with severe hypertension, myocardial ischemic disease, symptomatic valvular disease(s), symptomatic arrhythmia, uncompensated congestive heart failure, intracranial aneurysm.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01483495


Locations
United States, California
UCI Beckman Laser Institute
Irvine, California, United States, 92612
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Study Director: Bruce Tromberg, PhD Beckman Laser Institute
Principal Investigator: Lingzhong Meng, M.D Anesthesiology Perioperative Care
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, Lingzhong Meng, M.D.,Assistant Clinical Professor and Director of Neuroanesthesia, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01483495     History of Changes
Other Study ID Numbers: NIH-LAMMP-2010-7521
First Submitted: August 2, 2011
First Posted: December 1, 2011
Last Update Posted: February 10, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Ischemia
Hypoxia
Signs and Symptoms
Brain Ischemia
Hypoxia-Ischemia, Brain
Pathologic Processes
Signs and Symptoms, Respiratory
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain