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

This study is currently recruiting participants.
Verified January 2013 by Glostrup University Hospital, Copenhagen
Sponsor:
Information provided by (Responsible Party):
Johnny Andersen, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01760369
First received: December 20, 2012
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  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:

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

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

Primary Outcome Measures:
  • Change in regional cerebral oxygenation (rSO2) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Before, during and immediately after awaking from anesthesia


Secondary Outcome Measures:
  • Post anesthetic complications [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    During stay at the post anesthetic care unit. Any new neurological symptoms, pain from the neck, visual symptoms etc.


Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760369

Locations
Denmark
Glostrup Hospital Recruiting
Copenhagen, Glostrup kommune, Denmark, 2600
Contact: Johnny DH Andersen, Doctor     38630863     Johnnystudmed@hotmail.com    
Principal Investigator: Johnny DH Andersen, Doctor            
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
Principal Investigator: Johnny DH Andersen, Doctor Doctor
  More Information

No publications provided

Responsible Party: Johnny Andersen, Medical Doctor, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01760369     History of Changes
Other Study ID Numbers: NIRS-JDHA-12
Study First Received: December 20, 2012
Last Updated: January 14, 2013
Health Authority: Denmark: Ethics Committee. Protocolnumber: H-4-2012-FSP 102

ClinicalTrials.gov processed this record on June 17, 2013