Optimizing Breathing and Blood Flow for VA ECMO

(ECMO-VP Trial)

Overseen By Maurizio Bottiroli, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Pacemaker, IMPELLA, Pulmonary embolism, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve breathing and blood flow in patients receiving VA ECMO, a treatment that supports heart and lung function. Researchers seek to determine if adjusting lung air pressure based on specific tests can better balance lung function and blood flow. The trial suits adults already on mechanical ventilation and VA ECMO due to severe heart issues, such as heart failure or cardiac arrest. Participants must have been on ECMO for at least six hours and be stable according to the study team. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance treatment for serious heart conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this protocol is safe for optimizing breathing and blood flow?

Research has shown that improving breathing and blood flow during VA ECMO (a machine that supports the heart and lungs) is generally safe. Studies indicate that tools like electrical impedance tomography (which visualizes air movement in the lungs) and esophageal manometry (which measures pressure in the esophagus) help ensure the lungs receive the right balance of air and blood.

These methods have been used in other situations without major safety issues. For instance, ECMO with a safety protocol has been safe for patients with severe lung problems. Patients using ECMO usually tolerate these techniques well without serious complications.

While specific data from this study isn't available yet, past experiences suggest that these treatment methods are generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about optimizing breathing and blood flow in patients on VA ECMO because it offers a fresh approach to managing lung function. Unlike traditional methods, which primarily rely on standard ventilator settings, this technique uses advanced tools like electrical impedance tomography (EIT) to precisely measure lung perfusion and esophageal manometry to assess transpulmonary pressure. These innovative techniques aim to provide a more accurate picture of lung physiology, potentially leading to better-tailored ventilator settings and improved outcomes for patients.

What evidence suggests that optimizing breathing and blood flow is effective for VA ECMO?

Research has shown that improving breathing and blood flow during VA-ECMO (a machine that supports the heart and lungs) can enhance lung function. In this trial, participants will undergo a lung physiology assessment, which includes using PEEP (a ventilator setting that keeps the lungs open) and checking lung pressure. Studies have found that these methods can improve lung function. Early results suggest these approaches ensure the lungs receive enough air and blood, which is vital for patients on VA-ECMO. This approach aims to help the lungs and heart work together more effectively, potentially leading to better patient outcomes. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults on mechanical ventilation and VA ECMO support due to heart issues, who've been stable on ECMO for at least 6 hours. They must need a Swan-Ganz catheter as part of their care. People with pacemakers, IMPELLA devices, non-pulsatile pulmonary pressure, known pulmonary embolism, or those nearing life support withdrawal can't join.

Inclusion Criteria

Clinically stable in the estimation of the study investigator

I am an adult on a ventilator due to heart issues, receiving ECMO support.

On ECMO support for at least 6 hours

Exclusion Criteria

Contraindications to EIT (e.g., presence of pacemaker or IMPELLA device for electrical interference)

My heart's pulmonary pressure is non-pulsatile.

I have been diagnosed with a pulmonary embolism.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lung Physiology Assessment

Measurement of lung perfusion via EIT and transpulmonary pressure via esophageal manometry during decremental PEEP trial

1 hour

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Optimizing Breathing and Blood Flow

Trial Overview The study measures how well air and blood flow match up in patients using VA ECMO with ventilators. It tests if adjusting PEEP based on Electrical Impedance Tomography and esophageal pressure can improve lung function and this matching process.

How Is the Trial Designed?

Group I: Lung physiology assessment Experimental Treatment 1 Intervention

Measurement of lung perfusion (via EIT) and transpulmonary pressure (via esophageal manometry) during decremental PEEP trial

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11923310/

Optimising fluid therapy during venoarterial extracorporeal ... Optimising fluid therapy during venoarterial extracorporeal membrane oxygenation: current evidence and future directions

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.118.004905

Venoarterial Extracorporeal Membrane Oxygenation for ... Using large cannulas and modern pumps, VA-ECMO flow support can be high although flows more typically run ≈3 to 4 L/min. By draining blood directly from the ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0828282X19313911

Medical Optimization and Liberation of Adult Patients From ... The purpose of this paper is to discuss strategies to optimize patient management on VA-ECMO and approaches to promote successful separation from support.

4. alicantobidmc.org alicantobidmc.org/index.php/resources/optimizing-breathing-and-blood-flow-patients-treated-va-ecmo

Optimizing Breathing and Blood Flow in Patients Treated ... To explore the impact of PEEP titration based on esophageal pressure and EIT in terms of lung mechanics and V/Q matching.

5. aob.amegroups.org aob.amegroups.org/article/view/6889/html

Extracorporeal corporeal membrane oxygenation: indications ... VV ECMO drains venous blood (usually from the femoral vein, internal jugular vein, or directly from the right atrium), and oxygenated return is delivered to the ...

6. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-022-04102-0

Optimizing PO2 during peripheral veno-arterial ECMO During VA-ECMO support, several factors impact patient oxygen delivery: hemoglobin level, native lung function, oxygenator, native cardiac ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.067087

Scrutinizing the Role of Venoarterial Extracorporeal ... Percutaneous balloon atrial septostomy on top of venoarterial extracorporeal membrane oxygenation results in safe and effective left heart ...

8. journals.sagepub.com journals.sagepub.com/doi/10.1177/17534666241282590

Optimizing the safety and efficacy of the awake ... The awake ECMO strategy guided by safety protocol appears to be a safe approach in conscious, severely hypoxemic, non-intubated patients with COVID-19-related ...