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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Single Transpulmonary Thermodilution and Continuous Monitoring of Central Venous Oxygen Saturation During Off-pump Coronary Surgery

Conditions
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Coronary Artery Disease, Hemodynamic Monitoring,, Goal Directed Therapy

Intervention / Treatment
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* Device: Conventional monitoring
* Device: Advanced monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional monitoring<br>hemodynamic monitoring - conventional monitoring | Device: Conventional monitoring<br>* In the CM group, therapy was guided by central venous pressure, mean arterial pressure (MAP) and heart rate (HR)<br>* Other names: Non actual;|
| Active Comparator: Advanced monitoring<br>hemodynamic monitoring - advanced monitoring | Device: Advanced monitoring<br>* 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.<br>* Other names: PiCCO-CeVOX;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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venous oxygen saturation, transpulmonary thermodilution