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.
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.
Study Type
OBSERVATIONAL
Enrollment
136
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
Berlin, Germany
RECRUITINGSuccessful ECMO blood flow reduction
Number of patients with a relevant recirculation fraction and successful ECMO blood flow reduction
Time frame: Once within the first week after initiation of ECMO therapy
Recirculation fraction
Fraction of blood recirculating through the ECMO circuit
Time frame: Once within the first week after initiation of ECMO therapy
Arterial blood oxygen content
Arterial blood oxygen content before vs. after reduction of ECMO blood flow
Time frame: Once within the first week after initiation of ECMO therapy
Extracorporeal blood Flow
ECMO Blood Flow before vs. after reduction of ECMO blood flow
Time frame: Once within the first week after initiation of ECMO therapy
Extracorporeal gas flow
ECMO Sweep Gas flow
Time frame: Once within the first week after initiation of ECMO therapy
Length of ECMO therapy
Days on ECMO
Time frame: Daily until the end of ECMO therapy (approximately 14 days)
Cannula position and distance
The distance between the tip of drainage and return cannula will be measured in the existing medical imaging (e.g. CT scans)
Time frame: Once within the first week after initiation of ECMO therapy
Right heart dysfunction
Existing echocardiography will be evaluated for possible right heart dysfunction
Time frame: Once within the first week after initiation of ECMO therapy
Length of mechanical ventilation
Length of mechanical ventilation
Time frame: Entire duration of the ICU stay (approximately 28 days)
Complications of ECMO therapy
Incidence of cannula or system changes (i.e. due to circuit clotting), complications attributed to ECMO therapy like bleeding complications from the cannulation site, transfusion requirements, hemolysis
Time frame: Length of ECMO therapy (approximately 14 days)
ICU mortality
ICU mortality
Time frame: Entire duration of the ICU stay (approximately 28 days)
ICU length of stay
ICU length of stay
Time frame: Entire duration of the ICU stay (approximately 28 days)
Incidence of ICU-acquired organ dysfunctions and complications
Cerebral-, cardiovascular-, cardiac- pulmonary-, gastrointestinal- and renal dysfunctions, ICU-acquired infections
Time frame: Entire duration of the ICU stay (approximately 28 days)
ECMO blood flow over time
ECMO blood and sweep gas flow over time
Time frame: Daily until the end of ECMO therapy (approximately 14 days)
ECMO sweep gas flow over time
ECMO sweep gas flow over time
Time frame: Daily until the end of ECMO therapy (approximately 14 days)
Mobility at ICU discharge
Level of mobility the patient has reached at ICU discharge (recumbent, sitting, standing, walking with help, walking independently)
Time frame: Discharge from the ICU (approximately 28 days)
Weaning level at ICU discharge
Level of weaning reached at ICU discharge
Time frame: Discharge from the ICU (approximately 28 days)
Status of mechanical ventilation at ICU discharge
Status of mechanical ventilation at ICU discharge including all relevant settings and parameters
Time frame: Discharge from the ICU (approximately 28 days)
Level of organ dysfunction at ICU discharge
Sepsis-related Organ Failure Assessment Score at ICU discharge
Time frame: Discharge from the ICU (approximately 28 days)
Level of consciousness at ICU discharge
Glasgow Coma Scale at ICU discharge
Time frame: Discharge from the ICU (approximately 28 days)
Level of disease severity
Acute Physiology And Chronic Health Evaluation at ICU discharge
Time frame: Discharge from the ICU (approximately 28 days)
Hospital acquired infections related to ECMO therapy
Infection/colonisation of the ECMO circuit
Time frame: Entire duration of ECMO therapy
Bleeding and thrombembolic complications of ECMO therapy
Bleeding complications, thrombembolic events, overall use of blood products and coagulation factors, electron microscopic evaluation of selected membranes after change or weaning of the ECMO circuit
Time frame: Entire duration of ECMO therapy
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