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Assessing Cerebrovascular Reactivity Based on Cerebral Oximetry: a Pilot Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01483495
First received: August 2, 2011
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

At UCI Beckman laser Institute researchers want to use cerebral non-invasive oximetry instrument call Diffuse Optical Spectroscopy Imaging (DOSI)to assess cerebrovascular reactivity in human brain and has great temporal resolution, with details information about the brain oxygenation saturation and hemoglobin concentration.


Condition Intervention
Hypoxia-Ischemia, Brain
 Device: Cerebral Oximetry Diffuse optical spectroscopy imaging

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:
  • Optical Imaging assess of Brain blood flow during surgical procedure [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    The brain will be monitored use DOSI during surgery


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)
Intervention Details:
    Device: Cerebral Oximetry Diffuse optical spectroscopy imaging
    cerebral non-invasive oximetry instrument, assess cerebrovascular reactivity in surgical patients
    Other Name: DOSI, developed at UCI,Beckman Laser Institute,
Detailed Description:

This study does not involve medical intervention. DOSI is noninvasive and only involves data collection after the placement of a probe on the subject's forehead during surgery.

Subject who scheduled for elective surgery under general anesthesia at UCIMC will be recruited.

  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
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
Montana Compton
Investigators
Principal Investigator: Bruce Tromberg, PhD UCI Beckman Laser Institute
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01483495     History of Changes
Other Study ID Numbers: LAMMP DOS 30139
Study First Received: August 2, 2011
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013