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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00624494
Other study ID # 4347.07.2006
Secondary ID Grant 4347.07.20
Status Completed
Phase N/A
First received
Last updated
Start date May 2005
Est. completion date September 2008

Study information

Verified date March 2024
Source Northern State Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Intervention

Device:
Conventional monitoring
In the CM group, therapy was guided by central venous pressure, mean arterial pressure (MAP) and heart rate (HR)
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.

Locations

Country Name City State
Russian Federation Dep. of Anesthesiology, Northern SMU Arkhangelsk

Sponsors (2)

Lead Sponsor Collaborator
Northern State Medical University University of Tromso

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

Smetkin AA, Kirov MY, Kuzkov VV, Lenkin AI, Eremeev AV, Slastilin VY, Borodin VV, Bjertnaes LJ. Single transpulmonary thermodilution and continuous monitoring of central venous oxygen saturation during off-pump coronary surgery. Acta Anaesthesiol Scand. 2 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary length of hospital stay Length of the hospital stays, Days one month
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