Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients aged 18 years or older requiring veno-venous ECMO for treatment of refractory hypoxemia in ARDS.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful ECMO blood flow reduction | Once within the first week after initiation of ECMO therapy | Number of patients with a relevant recirculation fraction and successful ECMO blood flow reduction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Right heart dysfunction | Once within the first week after initiation of ECMO therapy | Existing echocardiography will be evaluated for possible right heart dysfunction |
| Length of mechanical ventilation | Entire duration of the ICU stay (approximately 28 days) | Length of mechanical ventilation |
| Recirculation fraction | Once within the first week after initiation of ECMO therapy | Fraction of blood recirculating through the ECMO circuit |
| Arterial blood oxygen content | Once within the first week after initiation of ECMO therapy | Arterial blood oxygen content before vs. after reduction of ECMO blood flow |
| Extracorporeal blood Flow | Once within the first week after initiation of ECMO therapy | ECMO Blood Flow before vs. after reduction of ECMO blood flow |
| Extracorporeal gas flow | Once within the first week after initiation of ECMO therapy | ECMO Sweep Gas flow |
| Length of ECMO therapy | Daily until the end of ECMO therapy (approximately 14 days) | Days on ECMO |
| Complications of ECMO therapy | Length of ECMO therapy (approximately 14 days) | 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 |
| ICU mortality | Entire duration of the ICU stay (approximately 28 days) | ICU mortality |
| ICU length of stay | Entire duration of the ICU stay (approximately 28 days) | ICU length of stay |
| Cannula position and distance | Once within the first week after initiation of ECMO therapy | The distance between the tip of drainage and return cannula will be measured in the existing medical imaging (e.g. CT scans) |
| ECMO blood flow over time | Daily until the end of ECMO therapy (approximately 14 days) | ECMO blood and sweep gas flow over time |
| ECMO sweep gas flow over time | Daily until the end of ECMO therapy (approximately 14 days) | ECMO sweep gas flow over time |
| Mobility at ICU discharge | Discharge from the ICU (approximately 28 days) | Level of mobility the patient has reached at ICU discharge (recumbent, sitting, standing, walking with help, walking independently) |
| Weaning level at ICU discharge | Discharge from the ICU (approximately 28 days) | Level of weaning reached at ICU discharge |
| Status of mechanical ventilation at ICU discharge | Discharge from the ICU (approximately 28 days) | Status of mechanical ventilation at ICU discharge including all relevant settings and parameters |
| Level of organ dysfunction at ICU discharge | Discharge from the ICU (approximately 28 days) | Sepsis-related Organ Failure Assessment Score at ICU discharge |
| Level of consciousness at ICU discharge | Discharge from the ICU (approximately 28 days) | Glasgow Coma Scale at ICU discharge |
| Level of disease severity | Discharge from the ICU (approximately 28 days) | Acute Physiology And Chronic Health Evaluation at ICU discharge |
| Hospital acquired infections related to ECMO therapy | Entire duration of ECMO therapy | Infection/colonisation of the ECMO circuit |
| Bleeding and thrombembolic complications of ECMO therapy | Entire duration 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 |
| Incidence of ICU-acquired organ dysfunctions and complications | Entire duration of the ICU stay (approximately 28 days) | Cerebral-, cardiovascular-, cardiac- pulmonary-, gastrointestinal- and renal dysfunctions, ICU-acquired infections |
Countries
Germany
Contacts
Primary ContactSteffen Weber-Carstens, Prof. Dr. med.
Backup ContactMartin Russ, Dr. med.
Outcome results
None listed