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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
  Purpose

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.


Condition
Aortic Arch Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Near Infrared Spectroscopy (NIRS) Neuro-monitoring During Deep Hypothermic Circulatory Arrest for Aortic Arch Surgery

Resource links provided by NLM:


Further study details as provided by Nonin Medical, Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: July 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cardiac disease
Aortic arch surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Mayo Clinic and affiliated hospitals

Criteria

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
  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: NCT01429324

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Nonin Medical, Inc
Investigators
Principal Investigator: James J Lynch, MD Mayo Clinic and affiliated hospitals
  More Information

No publications provided

Responsible Party: Nonin Medical, Inc
ClinicalTrials.gov Identifier: NCT01429324     History of Changes
Other Study ID Numbers: Mod11-000295-03
Study First Received: September 2, 2011
Last Updated: May 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Nonin Medical, Inc:
Near infrared spectroscopy
neuromonitoring
aortic arch surgery

ClinicalTrials.gov processed this record on November 25, 2014