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Study of the: Effect of Head Rotation in Prone Position on Regional Cerebral Oxygen Saturation. (NIRS)

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. Identifier: NCT01760369
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : November 14, 2013
Information provided by (Responsible Party):
Johnny Andersen, Glostrup University Hospital, Copenhagen

Brief Summary:
The purpose of this study is to determine whether head rotation in prone positon affects regional cerebral oxygenation (rSO2)in anesthetized patients undergoing lower back surgery.

Condition or disease
Regional Cerebral Oxygen Saturation During Head Rotation

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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observation Study of the: Effect of Head Rotation in Prone Position on Regional Cerebral Oxygen Saturation (rSO2) in Anesthetized Patients.
Study Start Date : October 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Primary Outcome Measures :
  1. Change in regional cerebral oxygenation (rSO2) [ Time Frame: 1 day ]
    Before, during and immediately after awaking from anesthesia

Secondary Outcome Measures :
  1. Post anesthetic complications [ Time Frame: 1 day ]
    During stay at the post anesthetic care unit. Any new neurological symptoms, pain from the neck, visual symptoms etc.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing lowerback surgery under universal anesthesia at Glostrup Hospital, Copenhagen.

Inclusion Criteria:

  • Lower back surgery
  • Age [18-80]
  • ASA group I-III
  • free and painless movement of the neck (including flexion, extension and rotation)

Exclusion Criteria:

  • Pain during neck movement as mentioned under inclusion criteria.
  • known history of cervical spine pathology or pathology of central nervous system including cerebrovascular disease
  • any stenosis of the carotid vessels or known symptoms associated with such
  • BMI > 35

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 identifier (NCT number): NCT01760369

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Glostrup Hospital
Copenhagen, Glostrup kommune, Denmark, 2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
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Principal Investigator: Johnny DH Andersen, Doctor Doctor
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Johnny Andersen, Medical Doctor, Glostrup University Hospital, Copenhagen Identifier: NCT01760369    
Other Study ID Numbers: NIRS-JDHA-12
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: November 14, 2013
Last Verified: January 2013