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Comparison of INVOS and FORE SIGHT Cerebral Oximeter

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by Johannes Gutenberg University Mainz.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01275898
First Posted: January 13, 2011
Last Update Posted: August 5, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johannes Gutenberg University Mainz
  Purpose
Cerebral oxygenation can be monitored using near infrared spectroscopy. Different devices are available to assess cerebral oxygenation noninvasively. Beach chair position is assumed to influence cerebral oxygenation. Litte is known about the influence of prone position and head down position on cerebral oxygenation. The investigators hypothesize that these positions influence cerebral oxygenation. Further the investigators presume that the two cerebral oximeters INVOS and ForeSight provide comparable oxygenation data.

Condition
Changes in Cerebral Oxygenation During Different Patient Positioning Coparison of Two Cerebral Oximeters

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Assessing Cerebral Oxygenation During Different Surgical Procedures - Comparison of INVOS and ForeSight Cerebral Oximeter

Further study details as provided by Johannes Gutenberg University Mainz:

Estimated Enrollment: 35
Study Start Date: April 2010
Groups/Cohorts
Beach chair
Patients scheduled for surgical procedure in beach chair position (Shoulder surgery)
Sitting position
Patients scheduled for surgical procedure in sitting position (Neurosurgery)
Head down position
Patients scheduled for surgical procedure in head down position (daVinci robotic surgery)
Prone position
Patients scheduled for surgical procedure in prone position

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients scheduled for surgical intervention in beach chair position, prone position and head down position
Criteria

Inclusion Criteria:

age >18 and <80 years written informed consent

Exclusion Criteria:

cerebrovascular disease coronary heart disease severe organ failure hemoglobin < 10mg/dl injury of forehead pregnancy

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01275898


Locations
Germany
Klinik für Anaesthesiologie Universitätsmedizin Mainz Recruiting
Mainz, Germany, 55131
Contact: Closhen       closhen@uni-mainz.de   
Sponsors and Collaborators
Johannes Gutenberg University Mainz