Comparative Analysis of Cerebral Oximetry and Mean Arterial Pressures at the Cerebral Level in the Beach Chair Position

NCT ID: NCT01645982

Last Updated: 2018-02-23

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

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-03-31

Brief Summary

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The purpose of this study is to compare the changes measured by Somanetics Invos cerebral oximeter to the mean arterial pressure at brain level in patients having elective shoulder replacement surgery. The Somanetics Invos System measures and monitors the oxygen saturation (rS02) of blood in the brain tissues to help prevent brain injury or other complications. The investigators hypothesize that maintaining normocarbia and systemic mean arterial pressure at or above 70mmHg during general anesthesia in the beach chair position will decrease the number of cerebral deoxygenation events during the procedure.

Detailed Description

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Conditions

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Cerebral Perfusion

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Subjects must be undergoing elective shoulder replacement surgery
* Subjects must have an ASA class of I or II
* Subject is able and willing to sign the informed consent
* Subject is 18 years of age or older at time of consent
* Subject is not pregnant
* Subject is not a prisoner

Exclusion Criteria

* Subject has a mental condition that may interfere with the subject's ability to give informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the subject cannot understand the informed consent process, global dementia, prior strokes that interfere with Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
* Subject is younger than 18 years of age at consent
* Subject is pregnant
* Subject is a prisoner
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paul Papagni

OTHER

Sponsor Role lead

Responsible Party

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Paul Papagni

Clinical Research Administrator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Holy Cross Orthopedic Research Institute

Fort Lauderdale, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20120943

Identifier Type: -

Identifier Source: org_study_id

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