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

Regional Cerebral Oxygen Saturation During Head Rotation Clinical Trial

— NIRS  

Official title:

Observation Study of the: Effect of Head Rotation in Prone Position on Regional Cerebral Oxygen Saturation (rSO2) in Anesthetized Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01760369
• Other study ID #: NIRS-JDHA-12
• Status: Completed
• Phase: N/A
• First received: December 20, 2012
• Last updated: November 13, 2013
• Start date: October 2012
• Est. completion date: April 2013

Study information

• Verified date: January 2013
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee. Protocolnumber: H-4-2012-FSP 102
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Regional Cerebral Oxygen Saturation During Head Rotation

Locations

Country	Name	City	State
Denmark	Glostrup Hospital	Copenhagen	Glostrup kommune

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in regional cerebral oxygenation (rSO2)	Before, during and immediately after awaking from anesthesia	1 day	No
Secondary	Post anesthetic complications	During stay at the post anesthetic care unit. Any new neurological symptoms, pain from the neck, visual symptoms etc.	1 day	No