Single Transpulmonary Thermodilution and Monitoring of Central Venous Oxygen Saturation (OPCAB)
Descriptive Information| Brief Title ICMJE | Single Transpulmonary Thermodilution and Monitoring of Central Venous Oxygen Saturation |
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| Official Title ICMJE | Single Transpulmonary Thermodilution Combined With Continuous Monitoring of Central Venous Oxygen Saturation During Off-Pump Coronary Artery Bypass Grafting: a Randomized Controlled Trial |
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| 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. |
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| 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. |
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| Study Phase | |
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| Study Type ICMJE | Interventional |
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| Study Design ICMJE | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
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| Condition ICMJE | Coronary Artery Disease |
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| Intervention ICMJE | - Device: PiCCO and CeVOX monitors (Pulsion Medical Systems)
All patients included were randomized into two groups of hemodynamic monitoring: conventional monitoring (CM) group (n = 20) and advanced monitoring (AM) group (n = 20). The CM group was managed according to heart rate (HR), central venous pressure, and mean arterial pressure (MAP). Other Name: venous oxygen saturation; transpulmonary thermodilution - Device: PiCCO and CeVOX monitors (Pulsion Medical Systems)
All patients included were randomized into two groups of hemodynamic monitoring: conventional monitoring (CM) group (n = 20) and advanced monitoring (AM) group (n = 20). In the AM group, therapy was guided by intrathoracic blood volume index and cardiac index determined with STD, MAP, HR, and continuous measurement of ScvO2.
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| Study Arms / Comparison Groups | - 2
hemodynamic monitoring - conventional monitoring Intervention: Device: PiCCO and CeVOX monitors (Pulsion Medical Systems) - 1
hemodynamic monitoring - advanced monitoring Intervention: Device: PiCCO and CeVOX monitors (Pulsion Medical Systems)
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Recruitment Information| Estimated Enrollment ICMJE | 40 |
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| Estimated Completion Date | March 2008 |
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| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) |
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| Eligibility Criteria ICMJE | 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
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| Gender | Both |
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| Ages | 18 Years to 90 Years |
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| Accepts Healthy Volunteers | No |
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| Contacts ICMJE | |
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| Location Countries ICMJE | Russian Federation |
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Administrative Information| NCT ID ICMJE | NCT00624494 |
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| Responsible Party | Mikhail Kirov, Professor, Northern State Medical University |
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| Study ID Numbers ICMJE | 4347.07.2006, Grant 4347.07.2006 |
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| Study Sponsor ICMJE | Northern State Medical University |
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| Collaborators ICMJE | |
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| Investigators ICMJE | | Study Director: | Mikhail Y Kirov | Northern SMU | |
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| Information Provided By | Northern State Medical University |
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