Back to resultsSingle Transpulmonary Thermodilution and Continuous Monitoring of Central Venous Oxygen Saturation During Off-pump Coronary Surgery (OPCAB)
Primary Purpose
Coronary Artery Disease, Hemodynamic Monitoring,, Goal Directed Therapy
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Conventional monitoring
Advanced monitoring
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring venous oxygen saturation, transpulmonary thermodilution
Eligibility Criteria
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
Sites / Locations
- Dep. of Anesthesiology, Northern SMU
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Conventional monitoring
Advanced monitoring
Arm Description
hemodynamic monitoring - conventional monitoring
hemodynamic monitoring - advanced monitoring
Outcomes
Primary Outcome Measures
length of hospital stay
Length of the hospital stays, Days
Secondary Outcome Measures
Full Information
NCT ID
NCT00624494
First Posted
February 13, 2008
Last Updated
January 4, 2011
Sponsor
Northern State Medical University
Collaborators
University of Tromso
1. Study Identification
Unique Protocol Identification Number
NCT00624494
Brief Title
Single Transpulmonary Thermodilution and Continuous Monitoring of Central Venous Oxygen Saturation During Off-pump Coronary Surgery
Acronym
OPCAB
Official Title
Single Transpulmonary Thermodilution and Continuous Monitoring of Central Venous Oxygen Saturation During Off-pump Coronary Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Northern State Medical University
Collaborators
University of Tromso
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Hemodynamic Monitoring,, Goal Directed Therapy
Keywords
venous oxygen saturation, transpulmonary thermodilution
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional monitoring
Arm Type
Active Comparator
Arm Description
hemodynamic monitoring - conventional monitoring
Arm Title
Advanced monitoring
Arm Type
Active Comparator
Arm Description
hemodynamic monitoring - advanced monitoring
Intervention Type
Device
Intervention Name(s)
Conventional monitoring
Other Intervention Name(s)
Non actual
Intervention Description
In the CM group, therapy was guided by central venous pressure, mean arterial pressure (MAP) and heart rate (HR)
Intervention Type
Device
Intervention Name(s)
Advanced monitoring
Other Intervention Name(s)
PiCCO-CeVOX
Intervention Description
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.
Primary Outcome Measure Information:
Title
length of hospital stay
Description
Length of the hospital stays, Days
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikhail Y Kirov
Organizational Affiliation
Northern SMU
Official's Role
Study Director
Facility Information:
Facility Name
Dep. of Anesthesiology, Northern SMU
City
Arkhangelsk
ZIP/Postal Code
163000
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
19183113
Citation
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. 2009 Apr;53(4):505-14. doi: 10.1111/j.1399-6576.2008.01855.x. Epub 2009 Jan 15.
Results Reference
result
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Single Transpulmonary Thermodilution and Continuous Monitoring of Central Venous Oxygen Saturation During Off-pump Coronary Surgery
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