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Cerebral Oximeter Comparison Study

NCT ID: NCT01655940

Last Updated: 2012-08-02

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

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-12-31

Brief Summary

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In this prospective study to try to standardize the care for patients, the investigators are planning to compare two cerebral oximeters currently in use at NCH in terms of their accuracy in determining the cerebral oxygen saturation as determined by jugular bulb oxygen saturation. Also, the investigators will compare these devices in terms of their response to changes in hemodynamics that occur during cardiac surgery.

Detailed Description

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Conditions

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Cardiac Bypass Patients

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac bypass patients

Somanetics cerebral oximeter

Intervention Type DEVICE

Somanetics cerebral oximeter

CASMED cerebral oximeter

Intervention Type DEVICE

CASMED cerebral oximeter

Interventions

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Somanetics cerebral oximeter

Somanetics cerebral oximeter

Intervention Type DEVICE

CASMED cerebral oximeter

CASMED cerebral oximeter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing cardiac surgery

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Aymen N Naguib

Director of Pediatric Cardiothoracic Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB11-00256

Identifier Type: -

Identifier Source: org_study_id