We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Near Infrared Spectroscopy (NIRS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01429324
First Posted: September 7, 2011
Last Update Posted: May 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nonin Medical, Inc
  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 ]

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Nonin Medical, Inc
ClinicalTrials.gov Identifier: NCT01429324     History of Changes
Other Study ID Numbers: Mod11-000295-03
First Submitted: September 2, 2011
First Posted: September 7, 2011
Last Update Posted: May 21, 2012
Last Verified: May 2012

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