Expanded ECLS Criteria and Strategies Domain (Expand-ECLS)
Study Status: Completed
Study Purpose: The goal of this study is to test if an artificial lung machine, VV-ECMO, can better support patients when their lungs are not working well, compared to usual support with a mechanical ventilator (breathing machine).
• VV-ECMO is a machine that adds oxygen and removes carbon dioxide from the blood
Background: Acute hypoxemic respiratory failure is a serious lung condition that affects many people in intensive care units (ICUs). Doctors use a gentle breathing support method to reduce harm from ventilators, which has helped lower death rates. But even this method can still cause damage.
VV-ECMO is a special machine that helps people breathe by adding oxygen and removing carbon dioxide from their blood. Studies in very severe patients show VV-ECMO can help some patients live longer and have fewer complications, especially if used early. It allows doctors to use even gentler settings on ventilators, which may protect the lungs better. Alternatively, VV-ECMO may be used to allow patients to be woken up and taken off the breathing machine earlier.
Study Methods: The treatment options being studied as part of this study are:
1. Ultra-protective Ventilation facilitated by VV-ECMO (ULTIMATE) (group receiving the new therapy)
• The patient will be connected to an ECMO machine that helps with breathing, using a large tube (cannula) inserted into a large vein in the patient’s neck. Sometimes, this may also involve a second tube to be inserted in a large vein in the groin
• For the first 2 days the patient will be unconscious, after these 2 days the doctors may wake up the patient if it is safe
• For 2 weeks the doctors will check on the patient daily to see if ECMO is still needed.
• After 2 weeks the ECMO machine will be removed (if the doctor thinks this is safe) the patient will remain on the ventilator with a setting to protect the lungs.
2. VV-ECMO-facilitated strategy of earlier awakening, extubation, and rehabilitation (PROACTIVE) (group receiving the new therapy)
• The patient will be connected to the ECMO machine as described above
• Once the patient is stable on ECMO, the doctors will help the patient breath on their own. They will do breathing tests to see if the breathing tube can be removed early
• The patient will receive rehabilitation as tolerated with a physical therapist, including before the tube is removed and while they are on ECMO
• ECMO will continue for up to 2 weeks or until ECMO is no longer needed
3. Conventional Lung-Protective Ventilation (LPV) (group receiving standard care)
• The patient will receive standard of care ventilation, similar to what they would receive if they were not part of the study
• The breathing machine gives small breaths and adjusts how fast the patient breathes to help remove carbon dioxide from the lungs
The patient will receive their assigned treatment for up to 2 weeks or until ECMO is no longer needed. The patient may be positioned face down for 16 hours a day to help with oxygen.
Health Conditions: Lungs & Breathing conditions
