UnknownNot Applicable

IMV to Accelerate Recovery of Lung Function in Veno-venous Extracorporeal Membrane Oxygenation; Lung Rest Or Moderate Mechanical Ventilation in ECMO

United Kingdom50 participantsStarted 2024-02-22

Plain-language summary

Feasibility trial to inform a future multicentre randomized control trial. The investigators aim to evaluate the feasibility of a trial of near apnoeic ventilation (two breaths per minute) compared with standard ventilation (respiratory rate between 10 and 30 breaths) for patients with acute respiratory distress syndrome (ARDS) supported with veno-venous extracorporeal membrane oxygenation (V-V ECMO). Additionally, when a patient is determined as ready to wean from ECMO the investigators will explore the feasibility of two ECMO weaning strategies and explore the physiological effects on respiratory effort and gas exchange.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria * Adult patients aged 18 years or older on the date of screening * Acute and potentially reversible cause of ARDS * Receiving invasive mechanical ventilation * Requiring ECMO for severe ARDS * Tidal volume ≥ 2.5ml/kg predicted body weight Exclusion criteria: Patients who meet the one or more of the following will be excluded from the trial. * Declined consent * \>12 hours following ECMO initiation * Patient likely to die or for withdrawal of life sustaining therapies within 24 hours * Use of V-A ECMO or hybrid ECMO modes * Current pregnancy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of patients receiving a ventilation strategy other than the assigned ventilation strategy over the 72 hour period following randomisation

Timeframe: During the 72 hours following randomisation

Trial details

NCT IDNCT06006676

SponsorGuy's and St Thomas' NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-01

Contact for this trial

Luigi Camporota, MD, PhD

02071883036 luigi.camporota@gstt.nhs.uk

View on ClinicalTrials.gov More ARDS trials