ECMO-Free Protocol for Extracorporeal Membrane Oxygenation Management

Enrolling by invitation at 7 trial locations

Overseen By Whitney D Gannon, MSN, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Pregnancy, Prisoner, Under 18, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if daily checks can safely expedite the discontinuation of ECMO (a machine that assists with breathing) for patients. It compares a new daily assessment routine, called the ECMO-free protocol, with usual care to identify which approach leads to better outcomes and shorter ECMO use. Patients currently on VV-ECMO in adult hospital units may be suitable candidates for this trial. The goal is to improve recovery and reduce healthcare costs. As an unphased study, this trial provides patients the opportunity to contribute to innovative research that could enhance recovery processes and lower healthcare expenses.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this ECMO-free protocol is safe for VV-ECMO management?

Research has shown that the ECMO-free protocol is generally safe for patients. In a previous study, 26 patients followed this protocol over 385 days. The results indicated that it helped identify patients ready to be taken off the ECMO machine sooner. This approach did not raise any major safety concerns.

Another study found that out of 83 patients removed from the ECMO machine, only two needed to be put back on. This suggests that the protocol can work well without causing significant issues. Overall, these studies suggest that the ECMO-free protocol is well-tolerated and can be a safe option for managing ECMO treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The ECMO-free protocol is unique because it aims to reduce the reliance on traditional ECMO management by introducing a structured, daily assessment approach. Unlike the current practice where ECMO weaning is largely based on clinicians' discretion, this protocol provides a standardized method to evaluate patients' readiness for ECMO decannulation. Researchers are excited about this trial because it could lead to more consistent and potentially faster weaning from ECMO, improving patient outcomes and optimizing resource use in critical care settings.

What evidence suggests that this trial's ECMO-free protocol could be effective for VV-ECMO management?

Research has shown that the ECMO-free protocol, which participants in this trial may receive, might help patients discontinue ECMO—a machine that supports breathing and heart function—sooner than usual methods. One study found that this approach is practical and may help doctors identify patients ready to come off ECMO earlier. This method involves daily checks to determine if a patient can safely stop using ECMO. In that study, 25% of patients were successfully taken off ECMO using this protocol, although a few needed to resume it. These findings suggest that this method might improve patient outcomes by reducing time on ECMO, but more research is needed to confirm these benefits. Meanwhile, the Usual Care group in this trial will follow standard ECMO weaning practices at the discretion of treating clinicians. ^{1 2 3 4 6}

Who Is on the Research Team?

Jonathan D Casey, MD, MSc

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adult patients currently receiving venovenous extracorporeal membrane oxygenation (VV-ECMO) in a participating hospital unit. It's not open to pregnant women, prisoners, minors under 18 years old, those on ECMO for over 24 hours, or individuals using it as a bridge to transplant.

Inclusion Criteria

You are currently receiving a special type of life support called VV-ECMO.

Patient is located in a participating unit of an adult hospital

Exclusion Criteria

Patient is pregnant

Patient is a prisoner

You have been on a heart-lung bypass machine called VV-ECMO for more than 24 hours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Initial Assessment

Participants are randomized to either the ECMO-free protocol or usual care group and initial assessments are conducted

1 week

1 visit (in-person)

Intervention

Daily protocolized assessments of readiness for liberation from VV-ECMO are conducted for the ECMO-free protocol group, while usual care is provided to the control group

Until decannulation or death

Follow-up

Participants are monitored for safety and effectiveness after decannulation

60 days

What Are the Treatments Tested in This Trial?

Interventions

• ECMO-free protocol
• Usual Care

Trial Overview

The study compares two approaches: the 'ECMO-free protocol' which involves daily assessments to determine if patients can safely stop using VV-ECMO versus 'Usual Care' where there isn't a set protocol for weaning off. The goal is to see if structured assessments improve outcomes and reduce time on ECMO.

How Is the Trial Designed?

Group I: The ECMO-free Protocol group Experimental Treatment 1 Intervention

For patients assigned to the ECMO-free protocol group, the study personnel will perform the ECMO-free protocol daily from enrollment until the first of death or ECMO decannulation; results will be recorded and shared with the treatment team. Final decisions regarding decannulation will be made by treating clinicians who are aware of the results of daily ECMO-free protocolized assessments.

Group II: The Usual Care Group Active Control 1 Intervention

For patients assigned to the usual care group, ECMO weaning and assessments of readiness for ECMO decannulation will be at the discretion of treating clinicians.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

Recent advancements in veno-arterial (VA) and veno-venous (VV) ECMO technology have improved support for patients with severe cardiac and pulmonary failure, making previously untreatable cases manageable.

Weaning from ECMO is crucial and should be considered as soon as patients show signs of recovery, but there are currently no standardized protocols, leading to variability in practices across different medical centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fundamentals of weaning veno-arterial and veno-venous extracorporeal membrane oxygenation. Tsiouris, A., Protos, AN., Saikus, CE., et al.[2023]

In a study of 83 patients weaned from VV-ECMO for severe ARDS, higher tidal volume and heart rate during the sweep gas-off trial were associated with a greater risk of unsafe liberation from ECMO, indicating these factors can help predict patient outcomes.

Patients who experienced unsafe liberation had significantly higher inspiratory efforts and longer durations of mechanical ventilation and ICU stays, suggesting that careful monitoring of respiratory mechanics is crucial for safe weaning from VV-ECMO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving Safe Liberation During Weaning From VV-ECMO in Patients With Severe ARDS: The Role of Tidal Volume and Inspiratory Effort. Al-Fares, AA., Ferguson, ND., Ma, J., et al.[2022]

Veno-venous extracorporeal membrane oxygenation (VV ECMO) is an effective rescue treatment for patients with acute respiratory distress syndrome (ARDS) that allows for gas exchange while reducing ventilator settings to help the lungs recover.

There is currently a lack of standardized guidelines for weaning patients off VV ECMO, as most studies do not detail the weaning process, highlighting the need for more research on the timing and criteria for safely discontinuing ECMO support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weaning from veno-venous extracorporeal membrane oxygenation: how I do it. Broman, LM., Malfertheiner, MV., Montisci, A., et al.[2023]

Weaning from venoarterial (VA) ECMO requires careful assessment of several key physiological parameters, including hemodynamic stability, lung function, and recovery of organ function, but there is currently no consensus on the best practices for patient selection or weaning methods.

Echocardiography is a critical tool used universally to evaluate cardiac function during the weaning process, highlighting its importance in determining a patient's readiness for decannulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to Turn It Down: The Evidence and Opinions Behind Adult Venoarterial Extracorporeal Membrane Oxygenation Weaning. Trahanas, JM., Li, SS., Crowley, JC., et al.[2022]

Implementing a daily assessment protocol for readiness to discontinue venovenous extracorporeal membrane oxygenation (ECMO) significantly reduced the duration of ECMO treatment from an average of 11 days to 5.5 days in patients with acute respiratory distress syndrome, based on a study of 180 patients from 2013 to 2019.

Patients assessed with the new protocol also experienced shorter times to the first sweep-off trial and reduced mechanical ventilation duration, leading to a decreased ICU length of stay, although there were no changes in overall hospital length of stay or survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Daily, Respiratory Therapist Assessment of Readiness to Liberate From Venovenous Extracorporeal Membrane Oxygenation in Patients With Acute Respiratory Distress Syndrome. Pratt, EH., Mausert, S., Wilson, MD., et al.[2022]

A systematic review of 1,467 citations identified 39 key publications on liberation from venovenous ECMO, highlighting the need for standardized criteria and protocols for safely and effectively liberating patients from this life-support system.

Current practices for ECMO liberation are inconsistent and largely depend on clinician preferences, indicating a significant gap in research that could improve patient outcomes and reduce complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liberation From Venovenous Extracorporeal Membrane Oxygenation for Respiratory Failure: A Scoping Review. Teijeiro-Paradis, R., Cherkos Dawit, T., Munshi, L., et al.[2023]

In a study of 262 patients who successfully underwent VA-ECMO decannulation, 27.5% did not survive to hospital discharge, with older age and pre-existing comorbidities being significant risk factors for mortality.

The most common causes of death post-decannulation were cardiovascular issues, infections, and neurological injuries, particularly within the first 8 days, highlighting the need for careful monitoring and infection prevention during this critical period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cause of In-Hospital Death After Weaning from Venoarterial-Extracorporeal Membrane Oxygenation. Bjelic, M., Kumar, N., Gu, Y., et al.[2022]

Current weaning strategies for veno-venous extracorporeal membrane oxygenation (VV-ECMO) are largely based on expert opinions rather than solid clinical evidence, leading to variability across different medical centers.

The article emphasizes the need for a standardized VV-ECMO weaning protocol in China to enhance patient outcomes and improve the overall prognosis for those receiving extracorporeal life support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Weaning of veno-venous extracorporeal membrane oxygenation: when to use the "resting lung"]. Wang, R., Sun, B.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05486559

Study Details | NCT05486559 | The ECMO-Free Trial

The ECMO-Free Protocol is a 3-step process of assessing readiness for liberation from VV-ECMO: a safety screen (Phase 1: ECMO-Free Safety Screen), titration of ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8727855/

Safety and Feasibility of a Protocolized Daily Assessment ...

The ECMO-free protocol is feasible and may identify patients for decannulation earlier than gradual approaches to weaning.

3.

journal.chestnet.org

journal.chestnet.org/article/S0012-3692(21)01342-8/fulltext

Standardizing the Approach to Liberation From Venovenous ...

Of the 83 patients liberated from VV-ECMO, 25% did not meet safety criteria after decannulation; two patients required recannulation. Factors that were ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0012369221011156

Safety and Feasibility of a Protocolized Daily Assessment ...

The ECMO-free protocol is feasible and may identify patients for decannulation earlier than gradual approaches to weaning.

5.

withpower.com

withpower.com/trial/phase-extracorporeal-membrane-oxygenation-complication-7-2022-7f32e

ECMO-Free Protocol for Extracorporeal Membrane ...

The ECMO-free protocol tests if patients can safely stop using ECMO by assessing their ability to tolerate mechanical ventilation without ECMO support.

6.

aging.networkofcare.org

aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05486559?keyword=%22Oxygenation%22

San Mateo Clinical Trial The ECMO-Free Trial

The results of this study, published in CHEST, suggested that a protocolized daily assessment of readiness for liberation from VV-ECMO is feasible and safe.