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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01760369
First Posted: January 4, 2013
Last Update Posted: November 14, 2013
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 (Responsible Party):
Johnny Andersen, Glostrup University Hospital, Copenhagen
  Purpose
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
Regional Cerebral Oxygen Saturation During Head Rotation

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Johnny Andersen, Glostrup University Hospital, Copenhagen:

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


Secondary Outcome Measures:
  • 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.


Enrollment: 52
Study Start Date: October 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
  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:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing lowerback surgery under universal anesthesia at Glostrup Hospital, Copenhagen.
Criteria

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
  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): NCT01760369


Locations
Denmark
Glostrup Hospital
Copenhagen, Glostrup kommune, Denmark, 2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
Principal Investigator: Johnny DH Andersen, Doctor Doctor
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johnny Andersen, Medical Doctor, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01760369     History of Changes
Other Study ID Numbers: NIRS-JDHA-12
First Submitted: December 20, 2012
First Posted: January 4, 2013
Last Update Posted: November 14, 2013
Last Verified: January 2013