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Can super-low breath volumes save COVID-19 patients on ventilators?

NCT ID NCT04349618

Disease control Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether using very small breaths (ultraprotective ventilation) on a breathing machine, without a heart-lung bypass machine, could improve survival and reduce time on the ventilator for COVID-19 patients with severe lung injury. About 220 adults with confirmed COVID-19 and moderate-to-severe ARDS were randomly assigned to either standard low-volume ventilation or ultra-low-volume ventilation. The goal was to see if the gentler approach lowers death rates and speeds recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ultraprotective ventilation (very low tidal volume mechanical ventilation)
What this could lead to
If successful, this breathing strategy could reduce lung damage and improve survival in severely ill COVID-19 patients on ventilators.
What could go wrong
This is a completed trial with 220 patients, but ultra-low tidal volume can cause dangerous acidosis. The benefit over standard care remains uncertain.

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

220 people

The number who actually took part.

Started

Apr 2020

Finished

Jun 2022

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: * Adults aged 18 years or older * ARDS according to the Berlin definition * COVID-19 pneumonia confirmed by RT-PCR * Acute respiratory failure not fully explained by left ventricular failure or sodium overload * Bilateral pulmonary radiological opacities not fully explained by pleural effusions or atelectasis or nodules * Invasive mechanical ventilation with PaO2/FiO2 ≤ 150 mm Hg and PEEP ≥ 5 cm H2O with a tidal volume below or equal to 6 ml per kilogram of predicted body weight * Continuous intravenous sedation as part of ARDS treatment Exclusion Criteria: * Exclusion criteria related to ARDS history * ARDS onset more than 48 hours before inclusion * previous inclusion in present study * Exclusion criteria related to ARDS severity or complications * arterial pH \< 7.21 despite respiratory rate set to 35/min at the time of inclusion * patient under any extracorporeal CO2 removal technique or ECMO * pneumothorax or bronchopleural fistula * Exclusion criteria related to comorbidities * suspected intracranial hypertension * severe chronic obstructive pulmonary disease defined by a GOLD score ≥ 3 * chronic respiratory failure under home oxygen or non-invasive ventilation * chronic respiratory failure requiring long term oxygen or non-invasive ventilation * obesity with body weight over height ratio greater than 1 kg/cm * sickle cell disease * bone marrow transplant \< 6 months * burn injury with extension greater than 30% of body surface area * cirrhosis with Child-Pugh score C * advance directives to withhold or withdraw life sustaining treatment * Exclusion criteria related to legislation * Patient under an exclusion period relative to participation to another clinical trial, or inclusion into a clinical trial interfering with the ventilatory strategies * pregnancy, lactating women * patient under a legal protective measure. * lack of affiliation to social security as required by French regulation * lack of written informed consent by patient or next of kin (unless if recourse to the emergency procedure in the absence of a loved one)

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome COVID-19 pneumonia

As listed by the trial registrant

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

Acute respiratory distress syndrome COVID19 Pneumonia SARS-COV2

Contacts and locations

Locations

  • Service de Médecine Intensive Réanimation CHU Gabriel Montpied

    Clermont-Ferrand, 63003, France

  • Service de Médecine Intensive Réanimation Hôpital Edouard Herriot Hospices Civils de Lyon

    Lyon, 69003, France

  • Service de Médecine Intensive Réanimation Hôpital Michallon - CHU Grenoble Alpes

    La Tronche, 38700, France

  • Service de Médecine Intensive Réanimation Hôpital Nord - CHU Saint-Etienne

    Saint-Priest-en-Jarez, 42055, France

  • Service de Médecine Intensive Réanimation Hôpital de la Croix Rousse Hospices Civils de Lyon

    Lyon, 69004, France

  • Service de Réanimation Centre hospitalier Annecy Genevois

    Pringy, 74374, France

  • Service de Réanimation Chirurgicale Hôpital Edouard Herriot Hospices Civils de Lyon

    Lyon, 69003, France

  • Service de Réanimation Chirurgicale Hôpital de la Croix Rousse Hospices Civils de Lyon

    Lyon, 69004, France

  • Service de Réanimation Clinique de la Sauvegarde

    Lyon, 69009, France

  • Service de Réanimation Polyvalente Centre Hospitalier Lyon Sud Hospices Civils de Lyon

    Pierre-Bénite, 69310, France

  • Service de réanimation Polyvalente Centre Hospitalier Saint Joseph-Saint Luc

    Lyon, 69007, France

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