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

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.

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Key information

Conditions

Cerebral Perfusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Holy Cross Orthopedic Research Institute

Fort Lauderdale, Florida, 33334, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Paul Papagni

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Jul 20, 2012
Registry last updated: Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed