Actively Recruiting
Validation of Techniques for Hemodynamic Monitoring and Prediction of Fluid Responsiveness in Patients Undergoing Venovenous Extracorporeal Membrane Oxygenation - A Prospective Diagnostic Accuracy Study
Led by Medical University of Vienna · Updated on 2025-09-29
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy of various methods for monitoring blood circulation during venovenous extracorporeal membrane oxygenation (VV ECMO) treatment. This treatment supports patients with severe respiratory failure by oxygenating blood outside the body. Continuous monitoring of heart function and blood flow is crucial in intensive care, but the artificial circulation in ECMO may affect common measurement tools. The study aims to validate specific techniques for assessing fluid responsiveness and circulation in this setting. Participants will undergo serial assessments using several devices and tests, including transthoracic echocardiography, uncalibrated pulse contour analysis, transpulmonary thermodilution, bioreactance, and esophageal doppler. Fluid responsiveness will be evaluated with maneuvers like passive leg raising, pulse pressure variation, stroke volume variation, inferior vena cava ultrasound, and occlusion tests. The study compares the performance of these tools throughout ECMO therapy. During the study, patients will have repeated measurements of cardiac output and heart function over days to weeks of ECMO treatment and up to seven days after its removal. Researchers will analyze data from different monitoring techniques and assess their ability to predict fluid responsiveness. The primary outcome focuses on agreement between cardiac output measurements using passive leg raising. Safety and diagnostic performance will also be monitored throughout the treatment period.
CONDITIONS
Brief Title
Hemodynamic Monitoring and Fluid Responsiveness in Venovenous Extracorporeal Membrane Oxygenation (VV ECMO) - "HemodynamECMOnitoring-VV Study"
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient receiving VV-ECMO support
- Age 18 - 75 years
You will not qualify if you...
- Pregnancy
- Conditions not allowing for passive leg raising maneuvers, such as open abdomen, suspected high intracranial pressure, recent leg or spinal trauma, or orthopedic issues preventing leg raising
- Known ischemic or hemorrhagic stroke within 3 months prior to enrollment
- Signs of raised intracranial pressure detected by pupil divergence or CT scan abnormalities such as compressed basal cisterns or midline shift greater than 5 mm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Throughout VV ECMO therapy, ranging from a few days up to 24 weeks
Participants undergo serial hemodynamic assessments using various monitoring devices and maneuvers to evaluate fluid responsiveness during VV ECMO therapy.
Repeated assessments throughout ECMO therapy and within up to 7 days after ECMO removal
Duration - Up to 7 days after ECMO removal
Participants are monitored with repeated measurements of cardiac output and related parameters after ECMO removal to evaluate recovery and fluid responsiveness.
Repeated visits within 7 days following ECMO removal
Trial Site Locations
Total: 1 location
1
Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
Research Team
B
Bernhard Nagler, MD
T
Thomas Staudinger, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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