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

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

Tracking Information
First Submitted Date December 20, 2012
First Posted Date January 4, 2013
Last Update Posted Date November 14, 2013
Study Start Date October 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 2, 2013)		 Change in regional cerebral oxygenation (rSO2) [ Time Frame: 1 day ]
Before, during and immediately after awaking from anesthesia
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 14, 2013)		 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.
Original Secondary Outcome Measures
 (submitted: January 2, 2013)		 Post anesthetic complications [ Time Frame: 1 day ]
During stay at the post anesthetic care unit. Any new neurological symptoms, pain from the neck, visual symtoms ect.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of the: Effect of Head Rotation in Prone Position on Regional Cerebral Oxygen Saturation.
Official Title Observation Study of the: Effect of Head Rotation in Prone Position on Regional Cerebral Oxygen Saturation (rSO2) in Anesthetized Patients.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients undergoing lowerback surgery under universal anesthesia at Glostrup Hospital, Copenhagen.
Condition Regional Cerebral Oxygen Saturation During Head Rotation
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Andersen JD, Baake G, Wiis JT, Olsen KS. Effect of head rotation during surgery in the prone position on regional cerebral oxygen saturation: A prospective controlled study. Eur J Anaesthesiol. 2014 Feb;31(2):98-103. doi: 10.1097/EJA.0000000000000028.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 13, 2013)		 52
Original Estimated Enrollment
 (submitted: January 2, 2013)		 40
Actual Study Completion Date April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT01760369
Other Study ID Numbers NIRS-JDHA-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Johnny Andersen, Glostrup University Hospital, Copenhagen
Study Sponsor Glostrup University Hospital, Copenhagen
Collaborators Not Provided
Investigators
Principal Investigator: Johnny DH Andersen, Doctor Doctor
PRS Account Glostrup University Hospital, Copenhagen
Verification Date January 2013