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

This study has been completed.
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01483495
First received: August 2, 2011
Last updated: August 5, 2015
Last verified: August 2015
  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 University of California, Irvine:

Primary Outcome Measures:
  • Brain blood flow [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 2, 2011
Last Updated: August 5, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 27, 2015