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Completed

NCT Number: NCT02352324

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

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.

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Key information

Conditions

Pulse Wave Analysis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dep. of Anesthesiology, Northern SMU

Arkhangelsk, 163000, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluid responsiveness tests

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Northern State Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 2, 2015
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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