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Near Infrared Spectroscopy (NIRS)

N

Nonin Medical

Status

Completed

Conditions

Aortic Arch Surgery

Study type

Observational

Funder types

Industry

Identifiers

NCT01429324
Mod11-000295-03

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Cardiac disease
Description:
Aortic arch surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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