Low-flow ECMO for Acute Respiratory Distress Syndrome

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Institute for Extracorporeal Life Support

Must be taking: Anticoagulants

Disqualifiers: Heart failure, Pulmonary embolism, Asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

Duration: 28 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called low-flow ECMO, a machine that assists with breathing, for individuals with severe respiratory issues like acute respiratory distress syndrome (ARDS). The trial investigates whether this less invasive option can safely support breathing while avoiding complications associated with current standard treatments, such as infections and lung injuries. Suitable candidates for this trial include those who have experienced new or worsening breathing problems within the last two weeks and have been on a breathing machine for five days or less. As an unphased trial, participants contribute to pioneering research that could lead to safer breathing support options.

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.

What prior data suggests that this low-flow ECMO is safe for acute respiratory distress syndrome?

Research has shown that low-flow ECMO, a type of life support that aids breathing, is promising in terms of safety for patients with severe respiratory issues. Studies suggest that ECMO can reduce the risk of death in patients with acute respiratory distress syndrome (ARDS) compared to traditional treatments.

One study found that patients using ECMO had a lower death rate at 60 days than those receiving standard care, indicating that ECMO might be a safer option for some patients. Although there is a risk of bleeding with low-flow ECMO, careful monitoring and medication to prevent blood clots can manage this risk.

Overall, despite some risks, low-flow ECMO has been shown to be well-tolerated in patients with severe breathing issues, offering a safer and less invasive alternative to traditional mechanical ventilation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about low-flow ECMO (Extracorporeal Membrane Oxygenation) for Acute Respiratory Distress Syndrome (ARDS) because it offers a potentially safer and more feasible alternative to traditional high-flow ECMO. Unlike high-flow ECMO, which requires significant blood flow and can lead to complications, low-flow ECMO uses reduced blood flow, which might minimize these risks. This approach aims to provide respiratory support while being easier to implement, especially in settings where resources and expertise are limited. By focusing on safety and feasibility, low-flow ECMO could expand the availability of ECMO therapy to more patients with ARDS.

What evidence suggests that low-flow ECMO is effective for acute respiratory distress syndrome?

Research has shown that low-flow ECMO, a type of life support, can help treat serious lung problems like ARDS by supporting breathing. One study found that ECMO lowered the risk of death in ARDS patients compared to regular treatments. In this trial, participants will receive low-flow ECMO, which uses smaller tubes and is less invasive than other methods, potentially leading to fewer complications. This system effectively removes carbon dioxide from the blood at lower rates, aiding in improved breathing. Although some risk of bleeding exists, careful management can help reduce these risks. ^{1 3 4 6 7}

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

I am a man or a woman not currently pregnant.

Admitted to the ICU at MHS

PaO2/FiO2 ≤ 200 mmHg for at least 6 hours, or for at least two readings one hour apart

Exclusion Criteria

I am expected to leave the ICU today.

I am receiving comfort care only or am in hospice.

The patient is moribund and deemed unlikely to survive past 24 hours (as determined by the clinical team)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are placed on Low-Flow ECMO by trained physicians, with monitoring of vital signs, ventilatory measurements, and LF ECMO settings.

28 days

Daily monitoring during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment, including collection of biospecimens and assessment of inflammatory markers.

90 days

Follow-up visits at 30, 60, and 90 days post-discharge

What Are the Treatments Tested in This Trial?

Interventions

• Low-flow ECMO

Trial Overview The study tests low-flow ECMO as an alternative to standard high-flow systems in patients with acute respiratory issues. It aims to reduce complications from mechanical ventilation by using smaller cannulas and lower blood flow rates (1-2.5 L/min).

How Is the Trial Designed?

Group I: Initiation of low-flow ECLS Experimental Treatment 1 Intervention

To evaluate the safety, feasibility, and efficacy of low-flow ECLS and assess the feasibility of its use

Who Is Running the Clinical Trial?

Institute for Extracorporeal Life Support

Lead Sponsor

Trials

1

Recruited

40+

Fresenius Medical Care North America

Industry Sponsor

Trials

40

Recruited

78,400+

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa1800385

Extracorporeal Membrane Oxygenation for Severe Acute ... At 60 days, 44 of 124 patients (35%) in the ECMO group and 57 of 125 (46%) in the control group had died (relative risk, 0.76; 95% confidence ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06938217

Safety and Efficacy of Low-Flow ECMO in a Multi-modal ... The investigators focus is to demonstrate the safety, feasibility, and efficacy of low-flow ECLS as a treatment for multiple respiratory conditions (including ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2213007118302053

Outcomes of extracorporeal membrane oxygenation in ... This study reports a single-center experience with the use of ECMO in critically ill adult patients treated for refractory hypoxemic ARDS with ECMO. This ...

4. atsjournals.org atsjournals.org/doi/10.1164/rccm.202212-2194OC

High- versus Low-Flow Extracorporeal Respiratory Support ... Compared with low-flow ECCO2R (0.4 L/min), high-flow ECMO (3–5 L/min) provides more rapid and better oxygenation. In addition, the possible ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7095017/

Outcome of acute respiratory distress syndrome patients ... Forty-two nonsurvivors died during therapy after a median (range) of 9 (1–53) days of ECMO, and 6 of them died after successful ECMO weaning after a median ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7537368/

ECMO for severe ARDS: systematic review and individual ... In this meta-analysis of individual patient data in severe ARDS, 90-day mortality was significantly lowered by ECMO compared with conventional management.

7. atsjournals.org atsjournals.org/doi/full/10.1164/rccm.202309-1688OC

Physiologic Effects of Extracorporeal Membrane ... Conclusions: In patients with severe acute respiratory distress syndrome, increased ECMO blood flow rate resulting in higher SvO2 decreases ...