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Clinical Trials/NCT02352324
NCT02352324
Completed
Not Applicable

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

Northern State Medical University1 site in 1 country20 target enrollmentJune 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulse Wave Analysis
Sponsor
Northern State Medical University
Enrollment
20
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
June 2014
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Northern State Medical University
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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

  • 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(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(Immediate postoperatively)

Study Sites (1)

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