Low-flow ECMO for Acute Respiratory Distress Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
The current standard of care (SOC) for treatment of patients with acute respiratory distress syndrome (ARDS), inhalation injury, volume overload, and/or pulmonary dysfunction is mechanical ventilation (MV). However, these techniques are associated with several complications after prolonged use, including risk of infection, increased sedation requirements, pulmonary edema, ventilator-induced lung injury (VILI), barotrauma, and multi-organ failure.Extracorporeal life support (ECLS) has been used to successfully minimize, replace, or avoid the use of MV. This concept is critical as it permits ultra-lung protective MV settings, mobilization, early ambulation of patients, and timely extubation (when appropriate).Conventional ECLS typically requires blood flows of 3-6 L/min, and its cannula sizes range from 21-25 Fr. This is by definition "high-flow" as it constitutes near-complete extracorporeal circulation of patient's circulating blood volume. On the other hand, low-flow ECLS at 1-2.5 L/min has been shown to prevent deleterious shifts in pH and PaCO2 at a lower level of invasiveness, and its cannula sizes range from 19-20 Fr dual lumen cannulas (which are associated with less serial dilation). The investigators propose the use of a low-flow circuit to include the NovaLung system in conjunction with a smaller tubing set and cannula to enable earlier utilization of ECLS with less invasiveness and smaller catheters. Specifically, the study will either utilize the Crescent RA cannula (or equivalent dual-lumen cannula) or use a 15-25 Fr cannula, both with 3/8 tubing/step-down tubing, as needed, for our study. A femoral (fem)-femoral or femoral-internal jugular (IJ) approach may also be used.Carbon dioxide is six times more diffusible than oxygen across the membrane; thus, carbon dioxide transfers can occur with high efficiency at our targeted blood flows of 1-2.5L/min. Oxygen can still transfer at these blood flows, and low flow can improve oxygen levels to some degree.There are three benchtop-based manuscripts that suggest that low-flow ECMO is associated with a potential increase in factors that increase the risk of bleeding complications/circuit changes. However, the manuscripts either tested \<1 L/min blood flow rates, or the effect of cannula size was not considered. None of them included the biological component of endothelial interaction. Mitigating the risk of bleeding complications by will be completed by administering anticoagulants with a target PTT of 40-50 seconds, and by monitoring the patients and their coagulation panels closely. There may be less risk of circuit clotting in our study because of chosen flow rates (1-2.5 L/min).
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, since anticoagulants will be administered, it's important to discuss your current medications with the trial team to ensure there are no interactions.
Is low-flow ECMO generally safe for humans?
Low-flow ECMO, like other ECMO systems, can have complications such as membrane oxygenator failure, but these are infrequent. Familiarity with the specific equipment can help detect and manage these issues early, and current systems generally maintain adequate blood flow without increasing the risk of blood damage.12345
How is Low-flow ECMO treatment different for ARDS?
Low-flow ECMO (extracorporeal membrane oxygenation) is unique because it provides oxygen to the blood outside the body, allowing the lungs to rest and heal, which is different from traditional ventilation methods that work by pushing air into the lungs. This treatment is particularly useful for patients with severe ARDS (acute respiratory distress syndrome) who do not respond well to standard ventilation therapies.678910
What data supports the effectiveness of the treatment Low-flow ECMO for Acute Respiratory Distress Syndrome?
Research shows that ECMO, a treatment that helps oxygenate the blood outside the body, can improve survival rates in patients with severe acute respiratory distress syndrome (ARDS). In one study, patients who received ECMO had a higher survival rate compared to those who did not, suggesting it can be an effective treatment option for ARDS.611121314
Who Is on the Research Team?
Jeffrey D DellaVolpe, MD, MPH
Principal Investigator
Institute for Extracorporeal Life Support
Are You a Good Fit for This Trial?
This trial is for adults with severe lung problems like ARDS or those needing mechanical ventilation. Participants must be able to tolerate low-flow ECMO, a less invasive support system for the lungs. Details on specific inclusion and exclusion criteria are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are placed on Low-Flow ECMO by trained physicians, with monitoring of vital signs, ventilatory measurements, and LF ECMO settings.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including collection of biospecimens and assessment of inflammatory markers.
What Are the Treatments Tested in This Trial?
Interventions
- Low-flow ECMO
Find a Clinic Near You
Who Is Running the Clinical Trial?
Institute for Extracorporeal Life Support
Lead Sponsor
Fresenius Medical Care North America
Industry Sponsor