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: August 7, 2013
Last verified: August 2013

August 2, 2011
August 7, 2013
December 2011
December 2011   (final data collection date for primary outcome measure)
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
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
Not Provided
Not Provided
Not Provided
Not Provided
 
Assessing Cerebrovascular Reactivity Based on Cerebral Oximetry: a Pilot Study
Assessing Cerebrovascular Reactivity Based on Cerebral Oximetry

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Elective surgery

Hypoxia-Ischemia, Brain
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,
Not Provided
Not Provided

*   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
LAMMP DOS 30139
No
Montana Compton, University of California, Irvine
Montana Compton
Not Provided
Principal Investigator: Bruce Tromberg, PhD UCI Beckman Laser Institute
University of California, Irvine
August 2013

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