Near-Infrared Spectroscopy Comparison Study

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

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-04-30

Brief Summary

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The objective of this study is to validate Near-Infrared (NIRS) monitoring in patients undergoing circulatory arrest. This study will compare two-wavelength NIRS INVOS System, Somanetics; Troy, MI) with four-wavelength NIRS (Nonin Medical, Inc; Plymouth, MN) to determine which modality best correlates with jugular venous oxygen saturation

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Detailed Description

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Conditions

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Total Aortic Arch Replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac Disease

Total Aortic Arch Replacement

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Provide written informed consent from patient or legally authorized representative before surgery
2. Adult patients 18-65 years of age
3. Presenting for elective or urgent total aortic arch repair under moderate hypothermic circulatory arrest (Nasopharyngeal temperature 20 - 24 ºC) with selective antegrade cerebral perfusion -

Exclusion Criteria

1. Patients will be excluded from this study if they are age less than 18
2. Are undergoing an emergent procedure
3. Have a history of insulin-dependent diabetes mellitus
4. Have a history of stroke
5. Are undergoing a redo sternotomy during which major bleeding occurs necessitating transfusion of \> 4 units of packed red blood cells prior to the institution of circulatory arrest
6. Patients in whom a left jugular venous bulb cannula cannot successfully be placed

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No