30 Participants Needed

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

Trial Summary

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 data supports the effectiveness of the treatment Low-flow ECMO for Acute Respiratory Distress Syndrome?

Research shows that ECMO, a treatment that helps oxygenate the blood outside the body, can improve survival rates in patients with severe acute respiratory distress syndrome (ARDS). In one study, patients who received ECMO had a higher survival rate compared to those who did not, suggesting it can be an effective treatment option for ARDS.12345

Is low-flow ECMO generally safe for humans?

Low-flow ECMO, like other ECMO systems, can have complications such as membrane oxygenator failure, but these are infrequent. Familiarity with the specific equipment can help detect and manage these issues early, and current systems generally maintain adequate blood flow without increasing the risk of blood damage.678910

How is Low-flow ECMO treatment different for ARDS?

Low-flow ECMO (extracorporeal membrane oxygenation) is unique because it provides oxygen to the blood outside the body, allowing the lungs to rest and heal, which is different from traditional ventilation methods that work by pushing air into the lungs. This treatment is particularly useful for patients with severe ARDS (acute respiratory distress syndrome) who do not respond well to standard ventilation therapies.311121314

What is the purpose of this trial?

The current standard of care (SOC) for treatment of patients with acute respiratory distress syndrome (ARDS), inhalation injury, volume overload, and/or pulmonary dysfunction is mechanical ventilation (MV). However, these techniques are associated with several complications after prolonged use, including risk of infection, increased sedation requirements, pulmonary edema, ventilator-induced lung injury (VILI), barotrauma, and multi-organ failure.Extracorporeal life support (ECLS) has been used to successfully minimize, replace, or avoid the use of MV. This concept is critical as it permits ultra-lung protective MV settings, mobilization, early ambulation of patients, and timely extubation (when appropriate).Conventional ECLS typically requires blood flows of 3-6 L/min, and its cannula sizes range from 21-25 Fr. This is by definition "high-flow" as it constitutes near-complete extracorporeal circulation of patient's circulating blood volume. On the other hand, low-flow ECLS at 1-2.5 L/min has been shown to prevent deleterious shifts in pH and PaCO2 at a lower level of invasiveness, and its cannula sizes range from 19-20 Fr dual lumen cannulas (which are associated with less serial dilation). The investigators propose the use of a low-flow circuit to include the NovaLung system in conjunction with a smaller tubing set and cannula to enable earlier utilization of ECLS with less invasiveness and smaller catheters. Specifically, the study will either utilize the Crescent RA cannula (or equivalent dual-lumen cannula) or use a 15-25 Fr cannula, both with 3/8 tubing/step-down tubing, as needed, for our study. A femoral (fem)-femoral or femoral-internal jugular (IJ) approach may also be used.Carbon dioxide is six times more diffusible than oxygen across the membrane; thus, carbon dioxide transfers can occur with high efficiency at our targeted blood flows of 1-2.5L/min. Oxygen can still transfer at these blood flows, and low flow can improve oxygen levels to some degree.There are three benchtop-based manuscripts that suggest that low-flow ECMO is associated with a potential increase in factors that increase the risk of bleeding complications/circuit changes. However, the manuscripts either tested \<1 L/min blood flow rates, or the effect of cannula size was not considered. None of them included the biological component of endothelial interaction. Mitigating the risk of bleeding complications by will be completed by administering anticoagulants with a target PTT of 40-50 seconds, and by monitoring the patients and their coagulation panels closely. There may be less risk of circuit clotting in our study because of chosen flow rates (1-2.5 L/min).

Research Team

JD

Jeffrey D DellaVolpe, MD, MPH

Principal Investigator

Institute for Extracorporeal Life Support

Eligibility Criteria

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
See 3 more

Exclusion Criteria

I am expected to leave the ICU today.
I am receiving comfort care only or am in hospice.
My shortness of breath is mainly due to heart failure.
See 19 more

Timeline

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

Treatment Details

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).
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Initiation of low-flow ECLSExperimental Treatment1 Intervention
To evaluate the safety, feasibility, and efficacy of low-flow ECLS and assess the feasibility of its use

Find a Clinic Near You

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+

References

Extracorporeal membrane oxygenation (ECMO) as a treatment strategy for severe acute respiratory distress syndrome (ARDS) in the low tidal volume era: A systematic review. [2022]
[Venovenous extracorporeal membrane oxygenation (ECMO) with a heparin-lock bypass system. An effective addition in the treatment of acute respiratory failure (ARDS)]. [2020]
Long-Term Quality of Life After Extracorporeal Membrane Oxygenation in ARDS Survivors: Systematic Review and Meta-Analysis. [2022]
[Use of extracorporeal membrane oxygenation in adults with acute respiratory distress syndrome: a meta-analysis]. [2020]
[Factors affecting the outcome of pulmonary-acute respiratory distress syndrome patients treated with veno-venous extracorporeal membrane oxygenation]. [2020]
Cerebral blood flow and oxygenation during venoarterial and venovenous extracorporeal membrane oxygenation in the newborn lamb. [2022]
Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for Patient- and Circuit-Related Adverse Events Involving Extracorporeal Membrane Oxygenation. [2020]
Flow dynamics of different adult ECMO systems: a clinical evaluation. [2014]
Low blood flow extracorporeal carbon dioxide removal (ECCO2R): a review of the concept and a case report. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Low vs standardized dose anticoagulation regimens for extracorporeal membrane oxygenation: A meta-analysis. [2021]
11.Korea (South)pubmed.ncbi.nlm.nih.gov
Extended Use of Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome: A Retrospective Multicenter Study. [2020]
Extracorporeal membrane oxygenation: experience in an adult medical ICU. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
High survival in adult patients with acute respiratory distress syndrome treated by extracorporeal membrane oxygenation, minimal sedation, and pressure supported ventilation. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
A novel strategy to improve systemic oxygenation in venovenous extracorporeal membrane oxygenation: the "χ-configuration". [2020]
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