RecruitingNot ApplicableNCT06593717

Hemodynamic Monitoring and Fluid Responsiveness in Venovenous Extracorporeal Membrane Oxygenation (VV ECMO) - "HemodynamECMOnitoring-VV Study"

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")


Sponsor

Medical University of Vienna

Enrollment

30 participants

Start Date

May 3, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria2

  • Patient receiving VV-ECMO support
  • Age 18 - 75 years

Exclusion Criteria4

  • 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 \> 5 mm.

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Interventions

DEVICETransthoracic Echocardiography

Transthoracic echocardiography (TTE) is used for intermittent non-invasive stroke volume (SV) measurements. It is calculated by multiplication of left ventricular out flow tract (LVOT) and LVOT velocity time integral (VTI), obtained in a parasternal long axis view and apical five chamber view, respectively.

DEVICEUncalibrated Pulse Contour Analysis

Pulse Contour Analysis allows an automated and continuous measurement of stroke volume (SV). Its underlying principle is that the integral of the systolic arterial pressure curve directly correlates with stroke volume.

DEVICETranspulmonary Thermodilution/Calibrated Pulse Contour Analysis

Transpulmonary thermodilution (TPTD) involves the administration of a cold saline bolus into a central venous catheter. A special thermistor catheter placed in the femoral or brachial artery detects the successive changes in blood temperature. The resulting heat dissipation curve is analyzed to estimate stroke volume, cardiac output and other hemodynamic variables such as intrathoracic thermal volume (ITTV), pulmonary thermal volume (PTV), global end-diastolic volume (GEDV), intrathoracic blood volume (ITBV) and extravascular lung water (EVLW). Intermittent TPTD-derived cardiac output measurements (typically performed 1-3x/d) are used to calibrate pulse contour analysis.

DEVICEEsophageal Doppler

In esophageal Doppler, a thin ultrasound probe, coated with aqueous ultrasound gel, is orally or nasally inserted into the esophagus and orientated towards the aorta. By emission and detection of continuous wave Doppler signals, real time spectral waveforms of red blood cell velocity in the aorta are obtained, from which cardiac indices can be derived.

DEVICEBioreactance

Bioreactance is a noninvasive hemodynamic monitoring technique, in which four double electrode sensors are placed on the skin of the chest. A high frequency sine wave is transmitted across the thorax. Pulsatile flow in the aorta causes phase shifts and amplitude changes of this signal, which are measured across the different electrodes and used to compute cardiac output.

DIAGNOSTIC_TESTPassive Leg Raising

Passive Leg Raising (PLR) is a maneuver that mimics a fluid challenge by shifting about 300 ml of venous blood from the lower body to the heart. Thereby, it can help to predict fluid responsiveness without actual fluid infusion. To start with, the patient is placed in a semi-recumbent position. Then, the bed is adjusted so that the patient's torso is moved to a horizontal position and the lower limbs are raised to an angle of 45°. Hemodynamic effects occur and can be measured within one minute.

DIAGNOSTIC_TESTVena Cava Ultrasound

Inferior Vena Cava (IVC) Ultrasound has become a popular technique for assessing volume status. IVC diameter is measured in a subcostal long-axis IVC view 1-2 cm from the junction with the right atrium. The magnitude of distensibility during mechanical ventilation cycles or collapsibility during spontaneous breathing has been proposed to correlate with fluid responsiveness

DIAGNOSTIC_TESTEnd-expiratory /-inspiratory occlusion test

In preload-dependent patients, mechanical ventilation induces periodic changes in cardiac output. Standardized maneuvers of end-expiratory or end-inspiratory interruption over 15 seconds may increase or decrease stroke volume, respectively, which is a valid predictor of fluid responsiveness

DRUGFluid bolus

To verify fluid responsiveness, 500 ml of balanced crystalloids will be infused over a time of 15-20 min (25-33.33 ml/min) after completion of passive leg raising and restoration of baseline patient positioning.


Locations(1)

Medical University of Vienna

Vienna, Austria

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