Cardiac Output Monitoring With Estimated Continuous Cardiac Output (esCCO) vs. Transpulmonary Thermodilution (TPTD)

Study Overview
=================
Brief Summary
-----------------
The main goal of our study is to assess the accuracy and reproducibility of continuous beat-to-beat cardiac output (CO) measurement using pulse wave transit time in patients undergoing off-pump coronary artery bypass grafting.

Detailed Description
-----------------
Using appropriate statistical methods the cardiac index values obtained via pulse wave transit time with esCCO system will be compared with traditional transpulmonary thermodilution technique.

Official Title
-----------------
Continuous Cardiac Output Monitoring Using esCCO: a Validation vs. Transpulmonary Thermodilution in Off-pump Coronary Artery Bypass Grafting

Conditions
-----------------
Pulse Wave Analysis [E01.370.370.680]

Intervention / Treatment
-----------------
* Other: Fluid responsiveness tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective isolated off-pump coronary arteries bypass grafting. Age > 18 years and < 80 yrs. Preoperative echocardiographic ejection fraction > 0.35 Exclusion Criteria: Simultaneous operation (carotid endarterectomy, ventricular aneurysm resection, etc.). Constant form of atrial fibrillation. Severe valve dysfunction. Peripheral vascular disease (including significant peripheral arteriopathy which precludes the use of peripheral plethysmography). The surgical requirement to harvest both radial arteries. Intraaortic balloon pump. Discontinuation Criteria: Transfer to cardiopulmonary bypass (on-pump CABG). The PEEP test will be discontinued before standard duration in patients with PEEP-induced profound MAP decrease below 50 mm Hg, bradycardia (< 50/min) or CIPCA < 1.9 l/min/m2 exceeding 1 minute.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluid responsiveness tests<br>After the end of surgery in ICU the positive end-expiratory pressure (PEEP) test of 15 cm H2O for 300 seconds will be performed. Following PEEP test, the two-step fluid load test of 6 ml/kg balanced crystalloid solution will be performed sharing in two portions: Initial mini FLT (mFLT) of 1.5 ml/kg within 1 min (approximately 100 mL) followed by the registration of continuous CI and traditional fluid responsiveness parameters and the rest of standard FLT (4.5 mL/kg) within 5 minutes (approximately 350 mL) followed by transpulmonary thermodilution, registration of continuous cardiac index (CI) and classic fluid responsiveness parameters. | Other: Fluid responsiveness tests<br>* After the end of surgery in ICU the positive end-expiratory pressure (PEEP) test of 15 cm H2O for 300 seconds will be performed. Following PEEP test, the two-step fluid load test of 6 ml/kg balanced crystalloid solution will be performed sharing in two portions: Initial mini FLT (mFLT) of 1.5 ml/kg within 1 min (approximately 100 mL) followed by the registration of continuous CI and traditional fluid responsiveness parameters and the rest of standard FLT (4.5 mL/kg) within 5 minutes (approximately 350 mL) followed by transpulmonary thermodilution, registration of continuous cardiac index (CI) and classic fluid responsiveness parameters.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy (between the method bias and angular bias) and precision (between the method standart deviation and radial limit of agreement) of esCCO cardiac output measurement | Mean bias and standard deviation according to Bland-Altman analysis and angular bias and radial limit of agreement according to polar plot analysis for cardiac output assessed using pulse wave transit time in comparison with transpulmonary thermodilution | Up to 24 hrs post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability of augmented PEEP test (changes in cardiac output in response to an increase in PEEP) for predict the fluid responsiveness (changes in cardiac output in response to fluid load) in the early postoperative period | Prediction of changes in cardiac output in response to fluid load in early postoperative period of off-pump CABG using the assessment of reaction of cardiac output to an increase in PEEP. Evaluation of correlation and ROC curve. | Immediate postoperatively | 
| Ability of mini fluid load test (changes in CO in response to fast injection of minimal fluid volume) to predict fluid responsiveness (changes in CO in response to injection of standard fluid volume) in the immediate postoperative period following OPCAB | Prediction of changes in cardiac output in response to fluid load in the immediate postoperative period following OPCAB using the assessment of reaction of cardiac output to an increase mini fluid load. Evaluation of correlation and ROC curve. | Immediate postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac output, coronary artery bypass grafting, minimally invasive hemodynamic monitoring, fluid responsiveness