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Near Infrared Spectroscopy (NIRS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nonin Medical, Inc
ClinicalTrials.gov Identifier:
NCT01429324
First received: September 2, 2011
Last updated: May 18, 2012
Last verified: May 2012

September 2, 2011
May 18, 2012
July 2011
May 2012   (final data collection date for primary outcome measure)
Evaluate brain tissue oxygenation assessing the number and percentage of subjects from whom regional data could be collected during 90% of the aortic arch surgery, and the registration rate during deep hypothermic circulatory arrest. [ Time Frame: At the end of the surgical case approximately 6 to 8 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01429324 on ClinicalTrials.gov Archive Site
Determine whether there are unilateral or global differences in cerebral tissue oxygenation detected during selective antegrade cerebral perfusion [ Time Frame: At the end of the surgical case approximately 6 to 8 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Near Infrared Spectroscopy (NIRS)
Validation of Near Infrared Spectroscopy (NIRS) Neuro-monitoring During Deep Hypothermic Circulatory Arrest for Aortic Arch Surgery

This study is designed to assess the feasibility of evaluating cerebral saturation during critical periods of deep hypothermia circulatory arrest and Selective Antegrade Cerebral Perfusion.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Mayo Clinic and affiliated hospitals

Aortic Arch Surgery
Not Provided
Cardiac disease
Aortic arch surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Is male or female
  • Is of any race or ethnicity
  • Is greater than or equal to eighteen (18) years of age
  • Weighs greater than or equal to 40 kilogram
  • Is not known to be pregnant
  • Understands English
  • Is undergoing aortic arch surgery with planned deep hypothermia circulatory arrest, either with or without select antegrade cerebral perfusion
  • Is able and willing to provide informed consent

Exclusion Criteria:

  • Is less than eighteen (18) years of age
  • Weighs less than 40 kilogram
  • Is known to be pregnant
  • Does not understand English
  • Has known sensitivity to adhesives
  • Is unable or unwilling to provide informed consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01429324
Mod11-000295-03
No
Nonin Medical, Inc
Nonin Medical, Inc
Not Provided
Principal Investigator: James J Lynch, MD Mayo Clinic and affiliated hospitals
Nonin Medical, Inc
May 2012

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