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

November 13, 2013 updated by: Johnny Andersen, Glostrup University Hospital, Copenhagen

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Glostrup kommune
      • Copenhagen, Glostrup kommune, Denmark, 2600
        • Glostrup Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing lowerback surgery under universal anesthesia at Glostrup Hospital, Copenhagen.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in regional cerebral oxygenation (rSO2)
Time Frame: 1 day
Before, during and immediately after awaking from anesthesia
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glostrup University Hospital, Copenhagen

Investigators

  • Principal Investigator: Johnny DH Andersen, Doctor, Doctor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

December 20, 2012

First Submitted That Met QC Criteria

January 2, 2013

First Posted (Estimate)

January 4, 2013

Study Record Updates

Last Update Posted (Estimate)

November 14, 2013

Last Update Submitted That Met QC Criteria

November 13, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • NIRS-JDHA-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Regional Cerebral Oxygen Saturation During Head Rotation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe