Reduction of Blood Recirculation in Veno-Venous ECMO
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Extracorporeal Membrane Oxygenation, Acute Respiratory Distress Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Reduction of Blood Recirculation in Veno-Venous ECMO Through Ultrasound Dilution Measurements (ECMO Circulation Study)
Overview
Blood which recirculates through the circuit of a veno-venous Extracorporeal Membrane Oxygenation (V-V ECMO) does not contribute to the systemic oxygenation of a patient on V-V ECMO and is called the recirculation fraction (Rf). Theoretically, the optimization of ECMO blood flow is possible using Rf measurements. A prospective, observational study will be performed measuring the Rf of total ECMO blood flow in patients with acute respiratory distress syndrome (ARDS) on V-V ECMO with an ultrasound dilution technique. ECMO blood flow will be optimized by reducing ECMO blood flow in accordance with the measured Rf as long as systemic oxygenation is not compromised.
Detailed description
Based on data from the 'Blood Recirculation and vvECMO' trial (ClinicalTrials.gov ID: NCT03200314) (i.e. an expected frequency of successful blood flow reduction of 66.7%), using a one-sample Chi square test, a two-sided type-1 error of 5%, a power of 80%, a total of 68 patients is needed to show that the proportion of patients with a secure ECMO blood flow reduction is greater than 50%. Presumably, 136 Patients have to be included into the trial to study 68 patients with a relevant Rf since not all patients on V-V ECMO suffer from a high Rf.
Primary outcome measures
- Successful ECMO blood flow reduction [Time frame: Once within the first week after initiation of ECMO therapy]
Secondary outcome measures (12)
- Recirculation fraction [Time frame: Once within the first week after initiation of ECMO therapy]
- Arterial blood oxygen content [Time frame: Once within the first week after initiation of ECMO therapy]
- Extracorporeal blood Flow [Time frame: Once within the first week after initiation of ECMO therapy]
- Extracorporeal gas flow [Time frame: Once within the first week after initiation of ECMO therapy]
- Length of ECMO therapy [Time frame: Daily until the end of ECMO therapy (approximately 14 days)]
- Cannula position and distance [Time frame: Once within the first week after initiation of ECMO therapy]
- Right heart dysfunction [Time frame: Once within the first week after initiation of ECMO therapy]
- Length of mechanical ventilation [Time frame: Entire duration of the ICU stay (approximately 28 days)]
- Complications of ECMO therapy [Time frame: Length of ECMO therapy (approximately 14 days)]
- ICU mortality [Time frame: Entire duration of the ICU stay (approximately 28 days)]
- ICU length of stay [Time frame: Entire duration of the ICU stay (approximately 28 days)]
- Incidence of ICU-acquired organ dysfunctions and complications [Time frame: Entire duration of the ICU stay (approximately 28 days)]
Eligibility criteria
Patients aged 18 years or older requiring veno-venous ECMO for treatment of refractory hypoxemia in ARDS.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum — Berlin
Identifiers
NCT: NCT04754854 · EA115620