ECMO-Free Protocol for Extracorporeal Membrane Oxygenation Management
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Vanderbilt University Medical Center
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.
Is the ECMO-free protocol a promising treatment?The ECMO-free protocol is a promising treatment because it aims to safely reduce the use of ECMO, a life-support machine, by helping patients recover their lung function. This approach can potentially shorten hospital stays and improve survival rates.23467
What safety data exists for ECMO weaning protocols?The safety of ECMO weaning protocols, including VV-ECMO liberation, is not well-documented. Studies highlight the lack of standardized criteria and protocols for safely weaning patients from ECMO. While some research discusses the importance of noninjurious mechanical ventilation and the potential benefits of reducing ECMO duration, there is limited evidence on specific safety data or predictors for successful weaning. Each center often follows its own protocols, and more research is needed to establish universal guidelines.12578
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. It's best to consult with the trial coordinators for more details.
What data supports the idea that ECMO-Free Protocol for Extracorporeal Membrane Oxygenation Management is an effective treatment?The available research shows that there is limited data on the effectiveness of ECMO-Free Protocol for Extracorporeal Membrane Oxygenation Management. While some studies discuss strategies for weaning patients from ECMO, they often rely on expert opinions rather than solid clinical evidence. There is no universally accepted protocol, and each medical center tends to follow its own methods. Therefore, it's challenging to definitively say how effective this treatment is compared to other alternatives, as the research does not provide clear outcome measures or data points.23467
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.Treatment Details
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: The ECMO-free Protocol groupExperimental Treatment1 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 GroupActive Control1 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.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Hennepin County Medical CenterMinneapolis, MN
Toronto General HospitalToronto, Canada
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
References
Weaning from veno-venous extracorporeal membrane oxygenation: how I do it. [2023]Veno-venous extracorporeal membrane oxygenation (VV ECMO) is a rescue treatment for acute respiratory distress syndrome (ARDS) failing protective mechanical ventilation. It temporarily provides proper gas exchange: hypoxia is treated by adjusting the blood flow rate and fraction in spired oxygen over the ventilator (FiO2) on the extracorporeal membrane oxygenation (ECMO) circuit while CO2 removal is regulated by the ECMO fresh gas flow. Therefore, ventilator settings can be gradually reduced allowing the lungs to rest and recover. Nowadays, indications for ECMO referral and implantation are clearly formulated; on the contrary, little evidence currently exists to guide the process of weaning from ECMO support, especially concerning the timing during the course of lung healing. Therefore, indications to stop ECMO are less well standardized so that in clinical trials extracorporeal assistance is generally continued until lung recovery, with neither specific nor homogenous criteria for withdrawal. Notably, in almost all papers dealing with data on VV ECMO support, the management of weaning and the weaning procedure itself are not described. The aim of this paper is to make a picture of VV ECMO weaning, as it is performed in three European large volume intensive care units (ICUs) which represent referral centers for VV ECMO treatment. We focused on data concerning the timing of VV ECMO weaning and parameters at the time of weaning, in order to assess adequacy and safety of VV ECMO removal.
Achieving Safe Liberation During Weaning From VV-ECMO in Patients With Severe ARDS: The Role of Tidal Volume and Inspiratory Effort. [2022]Weaning from venovenous extracorporeal membrane oxygenation (VV-ECMO) has not been not well studied. VV-ECMO can be discontinued when patients tolerate noninjurious mechanical ventilation (MV) during a sweep gas-off trial (SGOT). However, predictors of safe liberation are unknown.
How to Turn It Down: The Evidence and Opinions Behind Adult Venoarterial Extracorporeal Membrane Oxygenation Weaning. [2022]Adequate and durable recovery in patients supported with venoarterial (VA) extracorporeal membrane oxygenation (ECMO) can be challenging to predict. Extracorporeal membrane oxygenation weaning is the process by which the ECMO flows are decreased to assess if a patient is ready for decannulation. The optimal strategies for deciding who to wean and how to wean VA ECMO remain undefined. A retrospective literature review was performed to understand the evidence supporting current practices in ECMO weaning and in particular patient selection and methods. Most published work and expert opinions agree that once the underlying process has resolved, the minimum required physiologic parameters for weaning from ECMO include: hemodynamic stability and cardiac pulsatility, adequate lung function to support oxygenation and ventilation, and evidence of recovered end organ function. Echocardiography is universally used to assess cardiac function during the weaning process. Currently, there is no consensus regarding who is eligible to wean or how to wean ECMO in adults. We have reviewed the literature to summarize the evidence and expert opinions behind VA ECMO weaning, and give an example of the protocol used at our center. We believe this protocol optimizes patient selection for weaning and helps to predict successful decannulation.
A Daily, Respiratory Therapist Assessment of Readiness to Liberate From Venovenous Extracorporeal Membrane Oxygenation in Patients With Acute Respiratory Distress Syndrome. [2022]We assessed the effect of implementing a protocol-directed strategy to determine when patients can be liberated from venovenous extracorporeal membrane oxygenation on extracorporeal membrane oxygenation duration, time to initiation of first sweep-off trial, duration of mechanical ventilation, ICU length of stay, hospital length of stay, and survival to hospital discharge.
Cause of In-Hospital Death After Weaning from Venoarterial-Extracorporeal Membrane Oxygenation. [2022]A survival gap between weaning from venoarterial-extracorporeal membrane oxygenation (VA-ECMO) and the hospital discharge has been consistently reported. The aim of this study is to investigate the clinical features of patients who underwent successful VA-ECMO decannulation at our institution and to identify the major contributors responsible for adverse outcomes.
[Weaning of veno-venous extracorporeal membrane oxygenation: when to use the "resting lung"]. [2022]Differences in weaning strategies for veno-venous extracorporeal membrane oxygenation (VV-ECMO) are based on expert opinions rather than clinical evidence. Therefore, each center has its own "unique skills". The timing of VV-ECMO weaning has not received due attention. It is difficult to find research on the choice of VV-ECMO weaning timing in the database. There are few studies involving VV-ECMO that describe the weaning process in detail. At present, the weaning process of VV-ECMO is mainly based on expert opinions. This article classified the current VV-ECMO weaning strategies, appealed to a unified VV-ECMO weaning protocol in China as soon as possible, and further improved the prognosis of patients with extracorporeal life support.
Fundamentals of weaning veno-arterial and veno-venous extracorporeal membrane oxygenation. [2023]Recent advances in veno-arterial (VA) and veno-venous (VV) extracorporeal membrane oxygenation (ECMO) technology and management have enabled us to support patients with cardiac and/or pulmonary failure, who may have previously been considered untreatable. VA ECMO and VV ECMO are by definition transient therapies and serve as a bridge to recovery, bridge to decision, bridge to transplant, or bridge to no recovery. Weaning ECMO should be considered for all patients once native cardiac and pulmonary function show signs of recovery. Currently, there are no universally accepted protocols for weaning VA and VV ECMO, and consequently, each individual center follows their own weaning protocols. The aim of this review article is to describe different approaches to safely wean from VA and VV ECMO.
Liberation From Venovenous Extracorporeal Membrane Oxygenation for Respiratory Failure: A Scoping Review. [2023]Safe and timely liberation from venovenous extracorporeal membrane oxygenation (ECMO) would be expected to reduce the duration of ECMO, the risk of complications, and costs. However, how to liberate patients from venovenous ECMO effectively remains understudied.