Single Transpulmonary Thermodilution and Continuous Monitoring of Central Venous Oxygen Saturation During Off-pump Coronary Surgery (OPCAB)

March 20, 2024 updated by: Mikhail Y. Kirov, Northern State Medical University
The aim of the present study was to evaluate the usefulness of an algorithm based on hemodynamic parameters obtained by single transpulmonary thermodilution (STD) combined with continuous monitoring of central venous oxygen saturation (ScvO2) for perioperative management of patients undergoing OPCAB.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

At the present time, there is an increasing tendency to perform off-pump coronary artery bypass grafting (OPCAB). However, OPCAB poses a variety of challenges from the point of view of the anesthesiologist and the intensivist. The aim of the present study was to evaluate the usefulness of an algorithm based on hemodynamic parameters obtained by single transpulmonary thermodilution (STD) combined with continuous monitoring of central venous oxygen saturation (ScvO2) for perioperative management of patients undergoing OPCAB.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

  • Russian Federation
      • Arkhangelsk, Russian Federation, 163000
        • Dep. of Anesthesiology, Northern SMU

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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with coronary artery disease, ranked ASA II-III and scheduled for elective OPCAB

Exclusion Criteria:

  • Age < 18 years
  • Severe valve dysfunction or peripheral vascular disease
  • Simultaneous interventions (carotid endarterectomy, aneurysm repair, etc.)
  • Transfer to CPB during surgery

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional monitoring
hemodynamic monitoring - conventional monitoring
Device: Conventional monitoring
In the CM group, therapy was guided by central venous pressure, mean arterial pressure (MAP) and heart rate (HR)
Other Names:
  • Non actual
Active Comparator: Advanced monitoring
hemodynamic monitoring - advanced monitoring
Device: Advanced monitoring
In the AM group by the intrathoracic blood volume index, MAP, HR, central venous oxygen saturation (ScvO2) and cardiac index (CI). The measurements were performed before and during surgery, and at 2, 4 and 6 hrs post-operatively.
Other Names:
  • PiCCO-CeVOX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of hospital stay
Time Frame: one month
Length of the hospital stays, Days
one month

Collaborators and Investigators

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

Sponsor

Northern State Medical University

Collaborators

University of Tromso

Investigators

  • Study Director: Mikhail Y Kirov, Northern SMU

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

May 1, 2005

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

February 13, 2008

First Submitted That Met QC Criteria

February 26, 2008

First Posted (Estimated)

February 27, 2008

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4347.07.2006
  • Grant 4347.07.2006 (Other Identifier: HelseNord)

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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