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: June 10, 2015
Last verified: June 2015

August 2, 2011
June 10, 2015
December 2011
December 2011   (final data collection date for primary outcome measure)
Brain blood flow [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Optical Imaging assess of Brain blood flow during surgical procedure
Optical Imaging assess of Brain blood flow during surgical procedure [ Time Frame: during surgery procedure ] [ Designated as safety issue: No ]
The brain will be monitored use DOSI during surgery
Complete list of historical versions of study NCT01483495 on ClinicalTrials.gov Archive Site
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Assessing Cerebrovascular Reactivity Based on Cerebral Oximetry: a Pilot Study
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

Elective surgery

  • Hypoxia-Ischemia, Brain
  • Signs and Symptoms
Device: Diffuse optical spectroscopy
Diffuse Optical Spectroscopy Imaging Cerebrovascular Reactivity
Other Name: Diffuse Optical Spectroscopy Imaging
Diagnostic tool
Diffuse Optical Spectroscopy Imaging Cerebrovascular Reactivity
Intervention: Device: Diffuse optical spectroscopy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01483495
NIH-LAMMP-2010-7521
No
Beckman Laser Institute and Medical Center, University of California, Irvine
University of California, Irvine
Beckman Laser Institute University of California Irvine
Study Director: Bruce Tromberg, PhD Beckman Laser Institute
Principal Investigator: Lingzhong Meng, M.D Anesthesiology Perioperative Care
University of California, Irvine
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP