Study Concerning Relationship Between Mixed Venous Saturation (SvO2) and Balance

June 14, 2013 updated by: Rigshospitalet, Denmark

Descriptive Study Concerning the Connection Between SvO2 and Orthostatic Function Post Operatively

It is the purpose of the investigators to investigate the possible relationship between fall in the amount of Oxygen in the blood and disturbances of balance-function before and after surgery.

Study Overview

Status

Completed

Conditions

Detailed Description

It has been shown that the mixed venous saturation (SvO2) is usable as a parameter of fluid status. It has also been suggested that there is a connection between SvO2 and blood flow in tissue , and that a SvO2 of less than 40% is a sign of tissue hypoxia.

Recently it has been shown that patients going through heart surgery experience a drop in SvO2 during early mobilization.This drop lasts throughout the mobilisation process.

We want to investigate whether the same mechanism applies to patients going through other types of surgery, and whether there is a connection between a drop in SvO2 and orthostatic function.

This will be done by making 3 tests. One pre-operatively,one six hours post-operatively and one 18-24 hours after surgery.

The tests will consist of:

  1. 10 min of rest.
  2. 3 min of sitting upright on the side of the bed. C. 3 min of standing on the floor. D. 10 min of rest.

Between each position a venous blood sample will be taken. Also 1 blood sample will be taken at the end of surgery.

Continuous measurements by the Finapres system wil be made throughout the test-sequence to investigate changes in BP, SV, TPR and HR.

At the same time the patient will be pain-scored when taking a new position.

Study Type

Observational

Enrollment (Actual)

17

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
    • Seeland
      • Copenhagen, Seeland, Denmark, 2200
        • Rigshospitalet
      • Copenhagen, Seeland, Denmark, 2200
        • Dept of anesthesia 2041, ABD centre, Rigshospitalet, Blegdamsvej

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

Male

Description

Inclusion Criteria:

  • Patients going through Radical Prostatectomy, where CVC is standard.

Exclusion Criteria:

  • Non informed consent
  • ASA > II
  • Age less than 18, or more than 80 years
  • Diabetes Mellitus
  • Epidural analgetics
  • Alcohol abuse (investigators assessment)
  • Unable to understand written or spoken information
  • Using beta-blockers

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

Collaborators and Investigators

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

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Christoffer Joergensen, M.S.

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

February 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

February 5, 2007

First Submitted That Met QC Criteria

February 5, 2007

First Posted (Estimate)

February 6, 2007

Study Record Updates

Last Update Posted (Estimate)

June 17, 2013

Last Update Submitted That Met QC Criteria

June 14, 2013

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SvO2

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.

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