EXPAND-ECLS

Expanded ECLS Criteria and Strategies Domain

What is Expand-ECLS?

The Expanded ECLS Criteria and Strategies (Expand‑ECLS) Study is a pilot clinical trial evaluating whether it is feasible and safe to use veno-venous ECMO to support two innovative breathing strategies in adults with moderate to severe acute hypoxemic respiratory failure.

Why is this important?

People with acute respiratory failure or ARDS often require mechanical ventilation, which can unintentionally worsen lung injury despite careful settings. This study explores whether earlier use of VV‑ECMO can reduce that injury, enable gentler ventilation, and potentially support patients to awaken, breathe, and rehabilitate sooner — all steps that may improve survival, recovery, and long‑term quality of life.

What is involved in the study?

Participants who meet eligibility criteria will be randomly assigned to one of the study groups. While in the ICU, they will receive daily monitoring, specialized ventilator management, and (depending on the group) VV‑ECMO support. The research team will collect clinical data for up to 28 days in the ICU, then follow patients through hospital discharge and again at 60 and 180 days to evaluate health status and recovery.

Study Goals

Feasibility

Feasibility is measured by:

Recruitment success: enrolling 100 eligible patients within 2 years.
Protocol adherence: ensuring >80% of patients have <20% major protocol deviations.
Low crossover rates: keeping crossovers between arms below 10%.

Practicality & Safety

The study evaluates whether two approaches using VV‑ECMO can be applied safely and consistently across multiple centers:

ULTIMATE: ultra‑protective lung ventilation enabled by ECMO.
PROACTIVE: an ECMO‑facilitated approach focused on early awakening, extubation, and rehabilitation.

Validate Eligibility Criteria and Ventilation Protocols

Researchers aim to confirm that the inclusion/exclusion criteria and detailed ventilation protocols are appropriate, realistic, and reproducible across sites.

Gather Early Signals on Patient Recovery and Safety

Although this is not a full clinical trial, the study still collects information on:

complications
time on ventilators and ECMO
mobility and muscle strength
survival and quality of life

These outcomes help shape the future full‑scale trial.

Study Arms

ULTIMATE Arm

Participants receive VV‑ECMO so that their lungs can be rested with extremely gentle ventilation settings designed to reduce ventilator‑induced lung injury as much as possible.

Control Arm

Participants receive the current standard of care for mechanical ventilation, using established low‑tidal‑volume, lung‑protective settings without early use of VV‑ECMO unless medically required.

PROACTIVE Arm

VV‑ECMO is used as the primary means of respiratory support while sedation is reduced early, allowing patients to breathe spontaneously, be extubated sooner, and begin physical rehabilitation earlier in their illness.