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OpenTrials
Completed

NCT Number: NCT01429324

Near Infrared Spectroscopy (NIRS)

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.

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Key information

Conditions

Aortic Arch Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Nonin Medical, Inc

Industry

Registry information

Official study title

Validation of Near Infrared Spectroscopy (NIRS) Neuro-monitoring During Deep Hypothermic Circulatory Arrest for Aortic Arch Surgery

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 7, 2011
Registry last updated
May 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.