Comparison of INVOS and FORE SIGHT Cerebral Oximeter

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2010 by Johannes Gutenberg University Mainz.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Johannes Gutenberg University Mainz

ClinicalTrials.gov Identifier:

NCT01275898

First received: January 12, 2011

Last updated: August 4, 2011

Last verified: March 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	January 12, 2011
Last Updated Date	August 4, 2011
Start Date ^ICMJE	April 2010
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01275898 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Comparison of INVOS and FORE SIGHT Cerebral Oximeter
Official Title ^ICMJE	Assessing Cerebral Oxygenation During Different Surgical Procedures - Comparison of INVOS and ForeSight Cerebral Oximeter
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Patients scheduled for surgical intervention in beach chair position, prone position and head down position
Condition ^ICMJE	Changes in Cerebral Oxygenation During Different Patient Positioning Coparison of Two Cerebral Oximeters
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	35
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01275898
Other Study ID Numbers ^ICMJE	CLS_001
Has Data Monitoring Committee	No
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Johannes Gutenberg University Mainz
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Johannes Gutenberg University Mainz
Verification Date	March 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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