Clinical trial NCT06593717: Hemodynamic Monitoring and Fluid Responsiveness in Venovenous Extracorporeal Membrane Oxygenation (VV ECMO) - "HemodynamECMOnitoring-VV Study"
Official title: Validation of Techniques for Hemodynamic Monitoring and Prediction of Fluid Responsiveness in Patients Undergoing Venovenous Extracorporeal Membrane Oxygenation - a Prospective Diagnostic Accuracy Study ("HemodynamECMOnitoring-VV Study")
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ECMO Treatment
ARDS
Pneumonia
Intensive Care
Hemodynamic Monitoring
Fluid Responsiveness
Keywords: VV ECMO
Extracorporeal Membrane Oxygenation
ARDS
Intensive Care Medicine
Critical Care Medicine
Hemodynamic Monitoring
Fluid Responsiveness
Passive Leg Raising
Pulse Contour Analysis
Transpulmonary Thermodilution
Bioreactance
Pulse Pressure Variation
End-expiratory Occlusion Test
End-inspiratory Occlusion Test
Cardiac Output
LVOT VTI
Stroke Volume
Vena Cava Ultrasound
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 venovenous extracorporeal membrane oxygenation (VV ECMO). VV ECMO is commonly used for respiratory support in patients with severe acute respiratory failure. Blood is usually drained from a femoral vein, pumped through an oxygenator, where it is oxygenated and decarboxylated, and thereafter reinfused into the patient via a central venous, most commonly jugular, 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 VV ECMO.

In the context of this study, the performance of different hemodynamic monitoring tools and techniques for predicting fluid responsiveness will be compared.

Eligibility criteria: Inclusion Criteria:

* Patient receiving VV-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.

Suspicion of raised intracranial pressure is defined as pupil divergence (if not yet further clarified radiographically/neurologically/ophthalmologically) or signs detected in routine computed tomography scans (compressed or elapsed basal cisterns or midline shift \&gt; 5 mm.

Primary outcomes:
measure: 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).
timeFrame: 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.
Secondary outcomes:
measure: 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.
timeFrame: 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.
measure: Changes of cardiac output (L/min) over the course of ECMO therapy
timeFrame: 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.
measure: Changes of tricuspid annular plane systolic excursion (TAPSE, mm) over the course of ECMO therapy
timeFrame: 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.
measure: Changes of tissue doppler imaging tricuspid annular velocity (cm/s) over the course of ECMO therapy
timeFrame: 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.
measure: Changes in cardiac output (L/min, measured by transthoracic echocardiography, uncalibrated pulse contour analysis, thermodilution) at different ECMO blood flow rates
timeFrame: A few days (up to 5 days) before the expected ECMO removal: during ECMO weaning trial, i.e. zero ECMO gas flow
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: