Validation of Techniques for Hemodynamic Monitoring and Prediction of Fluid Responsiveness in Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation - A Prospective Diagnostic Accuracy Study ("HemodynamECMOnitoring-VA Study")
Overview
- Phase
- Not Applicable
- Intervention
- Transthoracic Echocardiography
- Conditions
- ECMO Treatment
- Sponsor
- Medical University of Vienna
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Agreement of receiver operating characteristic (ROC) curves for predicting fluid responsiveness using the passive leg-raising test between different cardiac output measurement techniques (echocardiography, pulse contour analysis, thermodilution).
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
In extracorporeal membrane oxygenation (ECMO), blood is drawn out of the body via tubes, oxygenated in an artificial lung; and then pumped back into the blood vessels. This allows the supply of oxygen-rich blood to the organs (brain, heart, lungs, kidneys, liver, intestines, etc.) to be maintained. Continuous monitoring of cardiac function and circulatory status (blood pressure, blood flow to organs) is very important in intensive care medicine in order to control the administration of circulation-supporting medication and infusions. Various devices are routinely used for this task. However, in the specific situation of ECMO treatment, the measurements of these devices could be affected due to the artificial circulation; outside the body. The purpose of this study is therefore to test the accuracy of different methods of circulation monitoring during ECMO treatment.
Detailed Description
Hemodynamic monitoring and tests for fluid responsiveness are cornerstones of intensive care medicine. Generally, hemodynamic measurements can be obtained, for instance, with the following methods: pulmonary artery catheter, transthoracic echocardiography (TTE), esophageal doppler, transpulmonary thermodilution, pulse contour analysis and bioreactance, amongst others. Maneuvers for assessing volume responsiveness include passive leg raising (PLR), respiratory pulse pressure variation (PPV), stroke volume variation (SVV), inferior vena cava ultrasound (IVC), and end-inspiratory or end-expiratory occlusion tests. While these commonly used methods of hemodynamic assessment have been validated in various clinical scenarios, data are lacking in the setting of venoarterial extracorporeal membrane oxygenation (VA ECMO). VA ECMO is commonly used for circulatory support in patients with severe hemodynamic failure or cardiac arrest. Blood is most commonly drained from a femoral vein, pumped through an oxygenator, where it is oxygenated and decarboxylated, and thereafter reinfused into the patient via an arterial, most commonly femoral, return cannula. Theoretically, the artificial circulation with its blood drainage and return flows may interfere with common hemodynamic monitoring techniques and lead to erroneous measurements. The aim of this study therefore is to validate select techniques of hemodynamic monitoring and assessment of fluid responsiveness in patients on VA ECMO. In the context of this study, the performance of different hemodynamic monitoring tools and techniques for predicting fluid responsiveness will be compared.
Investigators
Thomas Staudinger
Univ.-Prof. Dr.
Medical University of Vienna
Eligibility Criteria
Inclusion Criteria
- •Patient receiving VA ECMO support
- •Age 18 - 75 years
Exclusion Criteria
- •Pregnancy
- •Conditions not allowing for passive leg raising maneuvers, e.g. "open abdomen", known or suspected elevation of intracranial pressure, recent leg or spinal trauma or orthopedic conditions not permitting leg raising
- •Known ischemic or hemorrhagic stroke within 3 months prior to study enrollment.
Arms & Interventions
Entire Study Population
The entire study population will undergo serial hemodynamic assessments throughout the course of ECMO therapy. Hemodynamic variables are obtained using transthoracic echocardiography, uncalibrated pulse contour analysis, and optionally - depending on device availability - transpulmonary thermodilution, bioreactance and esophageal doppler. Maneuvers for assessing volume responsiveness include passive leg raising (PLR), respiratory pulse pressure variation (PPV), stroke volume variation (SVV), inferior vena cava ultrasound (IVC), and end-inspiratory or end-expiratory occlusion tests.
Intervention: Transthoracic Echocardiography
Entire Study Population
The entire study population will undergo serial hemodynamic assessments throughout the course of ECMO therapy. Hemodynamic variables are obtained using transthoracic echocardiography, uncalibrated pulse contour analysis, and optionally - depending on device availability - transpulmonary thermodilution, bioreactance and esophageal doppler. Maneuvers for assessing volume responsiveness include passive leg raising (PLR), respiratory pulse pressure variation (PPV), stroke volume variation (SVV), inferior vena cava ultrasound (IVC), and end-inspiratory or end-expiratory occlusion tests.
Intervention: Uncalibrated Pulse Contour Analysis
Entire Study Population
The entire study population will undergo serial hemodynamic assessments throughout the course of ECMO therapy. Hemodynamic variables are obtained using transthoracic echocardiography, uncalibrated pulse contour analysis, and optionally - depending on device availability - transpulmonary thermodilution, bioreactance and esophageal doppler. Maneuvers for assessing volume responsiveness include passive leg raising (PLR), respiratory pulse pressure variation (PPV), stroke volume variation (SVV), inferior vena cava ultrasound (IVC), and end-inspiratory or end-expiratory occlusion tests.
Intervention: Transpulmonary Thermodilution/Calibrated Pulse Contour Analysis
Entire Study Population
The entire study population will undergo serial hemodynamic assessments throughout the course of ECMO therapy. Hemodynamic variables are obtained using transthoracic echocardiography, uncalibrated pulse contour analysis, and optionally - depending on device availability - transpulmonary thermodilution, bioreactance and esophageal doppler. Maneuvers for assessing volume responsiveness include passive leg raising (PLR), respiratory pulse pressure variation (PPV), stroke volume variation (SVV), inferior vena cava ultrasound (IVC), and end-inspiratory or end-expiratory occlusion tests.
Intervention: Esophageal Doppler
Entire Study Population
The entire study population will undergo serial hemodynamic assessments throughout the course of ECMO therapy. Hemodynamic variables are obtained using transthoracic echocardiography, uncalibrated pulse contour analysis, and optionally - depending on device availability - transpulmonary thermodilution, bioreactance and esophageal doppler. Maneuvers for assessing volume responsiveness include passive leg raising (PLR), respiratory pulse pressure variation (PPV), stroke volume variation (SVV), inferior vena cava ultrasound (IVC), and end-inspiratory or end-expiratory occlusion tests.
Intervention: Bioreactance
Entire Study Population
The entire study population will undergo serial hemodynamic assessments throughout the course of ECMO therapy. Hemodynamic variables are obtained using transthoracic echocardiography, uncalibrated pulse contour analysis, and optionally - depending on device availability - transpulmonary thermodilution, bioreactance and esophageal doppler. Maneuvers for assessing volume responsiveness include passive leg raising (PLR), respiratory pulse pressure variation (PPV), stroke volume variation (SVV), inferior vena cava ultrasound (IVC), and end-inspiratory or end-expiratory occlusion tests.
Intervention: Passive Leg Raising
Entire Study Population
The entire study population will undergo serial hemodynamic assessments throughout the course of ECMO therapy. Hemodynamic variables are obtained using transthoracic echocardiography, uncalibrated pulse contour analysis, and optionally - depending on device availability - transpulmonary thermodilution, bioreactance and esophageal doppler. Maneuvers for assessing volume responsiveness include passive leg raising (PLR), respiratory pulse pressure variation (PPV), stroke volume variation (SVV), inferior vena cava ultrasound (IVC), and end-inspiratory or end-expiratory occlusion tests.
Intervention: Vena Cava Ultrasound
Entire Study Population
The entire study population will undergo serial hemodynamic assessments throughout the course of ECMO therapy. Hemodynamic variables are obtained using transthoracic echocardiography, uncalibrated pulse contour analysis, and optionally - depending on device availability - transpulmonary thermodilution, bioreactance and esophageal doppler. Maneuvers for assessing volume responsiveness include passive leg raising (PLR), respiratory pulse pressure variation (PPV), stroke volume variation (SVV), inferior vena cava ultrasound (IVC), and end-inspiratory or end-expiratory occlusion tests.
Intervention: End-expiratory /-inspiratory occlusion test
Entire Study Population
The entire study population will undergo serial hemodynamic assessments throughout the course of ECMO therapy. Hemodynamic variables are obtained using transthoracic echocardiography, uncalibrated pulse contour analysis, and optionally - depending on device availability - transpulmonary thermodilution, bioreactance and esophageal doppler. Maneuvers for assessing volume responsiveness include passive leg raising (PLR), respiratory pulse pressure variation (PPV), stroke volume variation (SVV), inferior vena cava ultrasound (IVC), and end-inspiratory or end-expiratory occlusion tests.
Intervention: Fluid bolus
Outcomes
Primary Outcomes
Agreement of receiver operating characteristic (ROC) curves for predicting fluid responsiveness using the passive leg-raising test between different cardiac output measurement techniques (echocardiography, pulse contour analysis, thermodilution).
Time Frame: Repeated measurements throughout ECMO therapy (duration ranging from a few days to up to 24 weeks) and within up to 7 days after ECMO removal. Separate analysis for controlled and assisted mechanical ventilation.
Cardiac Output (L/min) will be measured using transthoracic echocardiography, uncalibrated pulse contour analysis, and thermodilution before, during, and after a passive leg-raising test, as well as after administration of a fluid bolus of 500 ml balanced crystalloids over 15-20 min. A cardiac output increase of \> 15% will be the cut-off for defining fluid responsiveness. Receiver operating characteristic (ROC) curves will be generated for each cardiac output measurement technique and compared using the Hanley-McNeil method. The agreement between the ROC curves (Hanley-McNeil test statistic) will serve as the primary outcome.
Secondary Outcomes
- Diagnostic performance (receiver operating characteristic (ROC) area under the curve) of an inspiratory and expiratory occlusion test in conjunction with pulse contour analysis for the prediction of fluid responsiveness during ECMO.(Repeated measurements throughout ECMO therapy (duration ranging from a few days to several weeks) and within a few days after ECMO removal. Separate analysis for controlled and assisted mechanical ventilation.)
- Changes of cardiac output (L/min) over the course of ECMO therapy(Repeated measurements throughout ECMO therapy (duration ranging from a few days to up to 24 weeks) and within up to 7 days after ECMO removal.)
- Changes of tricuspid annular plane systolic excursion (TAPSE, mm) over the course of ECMO therapy(Repeated measurements throughout ECMO therapy (duration ranging from a few days to up to 24 weeks) and within up to 7 days after ECMO removal.)
- Changes of tissue doppler imaging tricuspid annular velocity (cm/s) over the course of ECMO therapy(Repeated measurements throughout ECMO therapy (duration ranging from a few days to up to 24 weeks) and within up to 7 days after ECMO removal.)
- Changes in cardiac output (L/min, measured by transthoracic echocardiography, uncalibrated pulse contour analysis, thermodilution) at different ECMO blood flow rates(During the first (up to 7) days of VA ECMO therapy.)