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

NCT02352324 | Completed

• 1 other identifier: esCCO-vs-TPTD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulse Wave Analysis

Keywords

cardiac output; coronary artery bypass grafting; minimally invasive hemodynamic monitoring; fluid responsiveness

Outcome Measures

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

  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 Outcomes (2)

• 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 Arms (1)

Fluid responsiveness tests

EXPERIMENTAL

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

Interventions

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.

Fluid responsiveness tests

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective isolated off-pump coronary arteries bypass grafting.
• Age \> 18 years and \< 80 yrs.
• Preoperative echocardiographic ejection fraction \> 0.35

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northern State Medical University: lead

Study Sites (1)

Dep. of Anesthesiology, Northern SMU

Arkhangelsk, 163000, Russia

Location

Study Officials

• Mikhail Y Kirov, MD, PhD

  Northern State Medical University

  STUDY DIRECTOR

• Alexey A Smetkin, MD

  Northern State Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: February 2, 2015
• Study Start: June 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

RU (1)