Clinical trial NCT02352324: Cardiac Output Monitoring With Estimated Continuous Cardiac Output (esCCO) vs. Transpulmonary Thermodilution (TPTD)
Official title: Continuous Cardiac Output Monitoring Using esCCO: a Validation vs. Transpulmonary Thermodilution in Off-pump Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulse Wave Analysis
Keywords: cardiac output
coronary artery bypass grafting
minimally invasive hemodynamic monitoring
fluid responsiveness
Lead sponsor: Northern State Medical University
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: 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
timeFrame: Up to 24 hrs post surgery
Secondary outcomes:
measure: 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
timeFrame: Immediate postoperatively
measure: 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
timeFrame: Immediate postoperatively
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: Dep. of Anesthesiology, Northern SMU
Study officials:
affiliation: Northern State Medical University
name: Mikhail Y Kirov, MD, PhD
role: STUDY_DIRECTOR
affiliation: Northern State Medical University
name: Alexey A Smetkin, MD
role: PRINCIPAL_INVESTIGATOR
References: