Testing monitoring methods for patients on ECMO support
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")
This study is testing different ways to monitor heart function and fluid levels in patients on ECMO support for severe breathing problems to see which methods work best.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT06593717 on ClinicalTrials.gov |
What this trial studies
This study evaluates the accuracy of various hemodynamic monitoring techniques in patients receiving venovenous extracorporeal membrane oxygenation (VV ECMO) for severe respiratory failure. It aims to determine how well these methods can assess cardiac function and fluid responsiveness in the unique context of artificial circulation. Techniques being tested include transthoracic echocardiography, pulse contour analysis, and transpulmonary thermodilution, among others. The goal is to validate these methods to ensure accurate monitoring during ECMO treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 who are receiving VV ECMO support.
Not a fit: Patients who are pregnant or have conditions that prevent passive leg raising maneuvers will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of patients on ECMO by providing reliable monitoring techniques that enhance patient outcomes.
How similar studies have performed: While hemodynamic monitoring techniques have been validated in various clinical scenarios, this specific application in the context of VV ECMO is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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 \> 5 mm.
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Study coordinator: Bernhard Nagler, MD
- Email: bernhard.nagler@meduniwien.ac.at
- Phone: +4314040044920
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.