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

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00431535
First received: February 5, 2007
Last updated: June 14, 2013
Last verified: October 2007
  Purpose

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.


Condition
Surgery

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Descriptive Study Concerning the Connection Between SvO2 and Orthostatic Function Post Operatively

Further study details as provided by Rigshospitalet, Denmark:

Enrollment: 17
Study Start Date: February 2007
Study Completion Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431535

Locations
Denmark
Dept of anesthesia 2041, ABD centre, Rigshospitalet, Blegdamsvej
Copenhagen, Seeland, Denmark, 2200
Rigshospitalet
Copenhagen, Seeland, Denmark, 2200
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Christoffer Joergensen, M.S.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00431535     History of Changes
Other Study ID Numbers: SvO2
Study First Received: February 5, 2007
Last Updated: June 14, 2013
Health Authority: Denmark: National Board of Health
Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:
Fluid
SvO2
Mobilisation
Orthostatic function

ClinicalTrials.gov processed this record on October 23, 2014