Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 12, 2011
August 4, 2011
April 2010
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT01275898 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison of INVOS and FORE SIGHT Cerebral Oximeter
Assessing Cerebral Oxygenation During Different Surgical Procedures - Comparison of INVOS and ForeSight Cerebral Oximeter

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.

Not Provided
Observational
Observational Model: Cohort
Not Provided
Not Provided
Probability Sample

Patients scheduled for surgical intervention in beach chair position, prone position and head down position

  • Changes in Cerebral Oxygenation During Different Patient Positioning
  • Coparison of Two Cerebral Oximeters
Not Provided
  • 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
Closhen D, Treiber AH, Berres M, Sebastiani A, Werner C, Engelhard K, Schramm P. Robotic assisted prostatic surgery in the Trendelenburg position does not impair cerebral oxygenation measured using two different monitors: A clinical observational study. Eur J Anaesthesiol. 2014 Feb;31(2):104-9. doi: 10.1097/EJA.0000000000000000.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
Not Provided
Not Provided

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

Both
18 Years to 80 Years
Yes
Germany
 
NCT01275898
CLS_001
No
Not Provided
Johannes Gutenberg University Mainz
Not Provided
Not Provided
Johannes Gutenberg University Mainz
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP