What we need to learn
When people become very sick and their lungs cannot give the body enough oxygen, they may need help from a machine that works like an external lung. This machine, called Veno‑Venous Extracorporeal Membrane Oxygenation (V-V ECMO), takes blood out of a patient’s vein, pushes oxygen into the blood and pulls carbon dioxide out of the blood, and returns the blood to the patient’s vein. While V-V ECMO saves lives, patients receiving V-V ECMO may also experience severe complications. Doctors try to take patients off V-V ECMO at the earliest time that it would be safe to do so. Hospitals use different methods to determine when to remove patients from VV-ECMO, but there is little research showing which approach works best.
A small study conducted at Vanderbilt Health suggested that checking every day to see if a patient is ready to come off V-V ECMO might help doctors stop the treatment sooner, without added risk. We need to test this idea in many hospitals to understand if daily protocolized check-ins can help patients stop V-V ECMO sooner, decrease complications, and improve recovery.
What we are doing
This research study is called ECMO-Free: A Multicenter Controlled Trial. The goal of the study is to learn whether a step-by-step daily protocol to check if patients are ready to stop V-V ECMO (called the ECMO-Free protocol) is better than usual care. Usual care varies from hospital to hospital and often depends on a doctor’s judgement, which can sometimes underestimate when a patient is ready to stop V-V ECMO. The daily ECMO-Free protocol uses a step-by-step approach to gradually decrease the support from V-V ECMO. Patients are monitored very closely during the entire process. If, at any time, their doctors determine that they should not continue to the next step, they will stay on V-V ECMO. This study will compare use of the daily ECMO-Free protocol to usual care to learn which approach helps patients come off V-V ECMO more quickly and safely.
This research is taking place in eight hospitals across the United States and Canada. Patients on VV-ECMO may be eligible to participate if they or their decision-makers consent to take part.
Participating in this study will not impact the quality of care patients receive. For each patient:
- If doctors think usual care is best for a patient, they will use those methods, and the patient will not take part in the study.
- If doctors think that either the daily, step-by-step protocol (ECMO-Free protocol) or usual care would be equally safe and effective for the patient, the patient or a family member will be approached for consent to be enrolled in the ECMO-Free Trial. If the patient or family member agrees to participate in the trial, the strategy to stop VV-ECMO will be randomly chosen by the study.
- If, at any time, doctors decide to not follow the daily, step-by-step ECMO-Free protocol and a different approach is needed for the patient’s care, they will treat them as they feel appropriate and document the reason for change.
Participating Sites
- Vanderbilt Health
- Baylor University Medical Center
- Hennepin County Medical Center
- Stanford University Medical Center
- Texas Tech University Health Sciences Center El Paso
- Toronto General Hospital
- University of California, San Diego Health
- University of Utah Hospital
FAQs
What is V-V ECMO?
V-V ECMO stands for Veno‑Venous Extracorporeal Membrane Oxygenation. The V-V ECMO machine works like an external lung by adding oxygen to the blood and removing carbon dioxide, which you normally breathe out. This machine is used for patients when their lungs cannot work well enough on their own, allowing their lungs to have time to recover.
What are the risks of the ECMO-Free trial protocol compared to usual care?
V-V ECMO is a complex but life-saving treatment. Patients on V-V ECMO are at risk of bleeding, blood clots, infection, or other complications. All of these risks are present no matter the method used to decide when to safely stop V-V ECMO.
Who is eligible for the ECMO-Free study?
- Adults who are receiving V-V ECMO in a participating hospital and are not receiving V-V ECMO as a bridge for transplant. People cannot volunteer to participate in the study at any other time
- Patients are eligible only if their doctors and nurses think that using either the ECMO-Free daily, step-by-step protocol or usual care to determine when V-V ECMO should be stopped would be consistent with optimal care for them.
Patients are eligible only if their doctors and nurses think that using either the ECMO-Free daily, step-by-step protocol or usual care to determine when V-V ECMO should be stopped would be consistent with optimal care for them.