Near Infrared Spectroscopy (NIRS)

NCT ID: NCT01429324

Last Updated: 2012-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Arch Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac disease

Aortic arch surgery

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nonin Medical, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James J Lynch, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic and affiliated hospitals

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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Mod11-000295-03

Identifier Type: -

Identifier Source: org_study_id

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