ECMO-Free Protocol for Extracorporeal Membrane Oxygenation Management

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Pregnancy, Prisoner, Under 18, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial aims to test a routine for checking if patients on a life-support machine can safely stop using it. The goal is to improve patient outcomes and reduce costs. The study will compare this routine to the usual care methods.

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 data supports the effectiveness of the ECMO-free protocol treatment?

The research suggests that implementing a protocol-directed strategy for weaning patients from venovenous extracorporeal membrane oxygenation (VV-ECMO) can potentially reduce the duration of ECMO support and improve outcomes like ICU and hospital length of stay, as well as survival to hospital discharge. ^{1 2 3 4 5}

Is the ECMO-Free Protocol generally safe for humans?

The safety of weaning from ECMO (a machine that helps with breathing and heart function) is not well-studied, and there are no standardized guidelines for safely stopping its use. However, the process is expected to reduce risks and costs if done safely, but more research is needed to understand how to do this effectively. ^{1 3 6 7 8}

How is the ECMO-free protocol treatment different from other treatments for managing ECMO?

The ECMO-free protocol is unique because it focuses on safely weaning patients from venovenous extracorporeal membrane oxygenation (VV-ECMO) by assessing their ability to tolerate noninjurious mechanical ventilation without the need for ECMO support. Unlike other treatments, this protocol aims to standardize the weaning process, which currently varies widely between centers and is often based on expert opinion rather than clinical evidence. ^{1 2 3 4 5}

Research Team

Jonathan D Casey, MD, MSc

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

Patient is < 18 years old

Trial Timeline

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

Treatment Details

Interventions

• ECMO-free protocol (Procedure)
• Usual Care (Other)

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.

Participant Groups

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+

Jeffrey R. Balser

Vanderbilt University Medical Center

Chief Executive Officer since 2009

MD and PhD from Vanderbilt University

Rick W. Wright

Vanderbilt University Medical Center

Chief Medical Officer since 2023

MD from University of Missouri-Columbia

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. United States 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. [2022]

3. India pubmed.ncbi.nlm.nih.gov

Fundamentals of weaning veno-arterial and veno-venous extracorporeal membrane oxygenation. [2023]

4. China pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

How to Turn It Down: The Evidence and Opinions Behind Adult Venoarterial Extracorporeal Membrane Oxygenation Weaning. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Liberation From Venovenous Extracorporeal Membrane Oxygenation for Respiratory Failure: A Scoping Review. [2023]

7. China pubmed.ncbi.nlm.nih.gov

Weaning from veno-venous extracorporeal membrane oxygenation: how I do it. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Cause of In-Hospital Death After Weaning from Venoarterial-Extracorporeal Membrane Oxygenation. [2022]