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New ventilator strategy aims to save lives in severe lung failure

NCT ID NCT03963622

Disease control Sponsor: Unity Health Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether setting a breathing machine based on each patient's lung mechanics can lower the chance of death within 60 days for people with acute respiratory distress syndrome (ARDS). It includes both COVID-19 and non-COVID-19 patients. The approach is compared to standard ventilation care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 740 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2020

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 y 2. Moderate or severe ARDS (PaO2/FiO2 ≤ 200 mmHg) within 48 h of meeting Berlin ARDS criteria (Patients who were eligible at the time of screening and whose PaO2/FiO2 became \> 200 mm Hg under prone positioning when starting the protocol remained eligible) Exclusion Criteria: 1. Received continuous mechanical ventilation \> 7 days 2. Known or clinically suspected elevated intracranial pressure (\>18mmHg) necessitating strict control of PaCO2 3. Known pregnancy 4. Broncho-pleural fistula 5. Severe liver disease (Child-Pugh Score ≥ 10) 6. BMI \>40kg/m2 7. Anticipating withdrawal of life support and/or shift to palliation as the goal of care 8. Patient is receiving ECMO at time of randomization

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome COVID-19 Respiratory Aspiration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ARDS

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    33 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arcispedale Sant'Anna

    RECRUITING

    Ferrara, Italy

  • CH Bretagne Atlantique Vannes-Auray

    RECRUITING

    Vannes, France

  • CH Victor Dupouy

    RECRUITING

    Argenteuil, France

  • CH de Beauvais

    RECRUITING

    Beauvais, France

  • CH de Cholet

    RECRUITING

    Cholet, France

  • CHU Amiens-Picardie

    RECRUITING

    Amiens, France

  • CHU Bordeaux - Haut Leveque

    RECRUITING

    Bordeaux, France

  • CHU Grenoble-Alpes

    RECRUITING

    Grenoble, France

  • CHU de Poitiers - La Miletrie

    RECRUITING

    Poitiers, France

  • Centre hospitalier universitaire d'Angers

    RECRUITING

    Angers, France

  • Centro de Educación Médica e Investigaciones Clínicas Dr Norberto Quirno (CEMIC)

    RECRUITING

    Buenos Aires, Argentina

  • Complejo Médico Policía Federal Argentina Churruca Visca

    RECRUITING

    Buenos Aires, Argentina

  • Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

    RECRUITING

    Mulhouse, France

  • HIA Robert Picque

    RECRUITING

    Villenave-d'Ornon, France

  • Hopital Europeen Georges-Pompidou

    RECRUITING

    Paris, France

  • Hopital Intercommunal de Creteil

    RECRUITING

    Créteil, France

  • Hopital Roger Salengro - CHU Lille

    RECRUITING

    Lille, France

  • Hopital de l'Archet 1 - CHU de Nice

    RECRUITING

    Nice, France

  • Hopital de la Cavale Blanche - CHRU Brest

    RECRUITING

    Brest, France

  • Hospital Británico de Buenos Aires

    RECRUITING

    Buenos Aires, Argentina

  • L'Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, Spain

  • New York University Grossman School of Medicine

    RECRUITING

    New York, New York, 10016, United States

  • OLVG

    RECRUITING

    Amsterdam, North Holland, Netherlands

  • Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Rome, Italy

  • Pontificia Universidad Católica de Chile

    RECRUITING

    Santiago, Chile

  • Sanatorio Anchorena Recoleta

    RECRUITING

    Buenos Aires, Argentina

  • Sanatorio Anchorena San Martín

    RECRUITING

    San Martin, Argentina

  • Sanatorio Mater Dei

    RECRUITING

    Buenos Aires, Argentina

  • St. Michael's Hospital

    RECRUITING

    Toronto, Canada

  • Toronto General Hospital

    RECRUITING

    Toronto, Canada

  • Toronto Western Hospital

    RECRUITING

    Toronto, Canada

  • University of Foggia

    RECRUITING

    Foggia, Italy

  • Vall d'Hebron University Hospital

    RECRUITING

    Barcelona, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.