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

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ClinicalTrials.gov Identifier: NCT02352324
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : February 2, 2015
Sponsor:
Information provided by (Responsible Party):
Northern State Medical University

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.

Condition or disease Intervention/treatment Phase
Pulse Wave Analysis [E01.370.370.680] Other: Fluid responsiveness tests Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Continuous Cardiac Output Monitoring Using esCCO: a Validation vs. Transpulmonary Thermodilution in Off-pump Coronary Artery Bypass Grafting
Study Start Date : June 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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Arm Intervention/treatment
Experimental: Fluid responsiveness tests
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
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.




Primary Outcome Measures :
  1. 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 [ Time Frame: Up to 24 hrs post surgery ]
    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


Secondary Outcome Measures :
  1. 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 [ Time Frame: Immediate postoperatively ]
    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.

  2. 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 [ Time Frame: Immediate postoperatively ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352324


Locations
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Russian Federation
Dep. of Anesthesiology, Northern SMU
Arkhangelsk, Russian Federation, 163000
Sponsors and Collaborators
Northern State Medical University
Investigators
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Study Director: Mikhail Y Kirov, MD, PhD Northern State Medical University
Principal Investigator: Alexey A Smetkin, MD Northern State Medical University
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Responsible Party: Northern State Medical University
ClinicalTrials.gov Identifier: NCT02352324    
Other Study ID Numbers: esCCO-vs-TPTD
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: January 2015
Keywords provided by Northern State Medical University:
cardiac output
coronary artery bypass grafting
minimally invasive hemodynamic monitoring
fluid responsiveness