Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06593717

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient receiving VV-ECMO support
  • Age 18 - 75 years
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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