Acute Respiratory Distress SyndromeVT4COVIDNCT04349618
Ultraprotective Ventilation Without Extracorporeal Circulation During COVID 19 Pneumonia
A study testing PROTECTIVE VENTILATION and ULTRAPROTECTIVE VENTILATION in people with Acute Respiratory Distress Syndrome and COVID19, run by Hospices Civils de Lyon at 11 sites in France.
Trial summary
Mortality of COVID-19 pneumonia with acute respiratory distress syndrome (ARDS) is extremely high in preliminary reports amounting to 50-60%. Duration of mechanical ventilation in these patients appears to exceed standard duration of mechanical ventilation in non-COVID-19 ARDS patients, suggesting that COVID-19… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, COVID19, Sars-CoV2
- What is being tested?
- PROTECTIVE VENTILATION and ULTRAPROTECTIVE VENTILATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 11 sitesFrance
- Study dates
- 15 Apr 2020to 16 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
- 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)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Service de Médecine Intensive Réanimation CHU Gabriel Montpied
Clermont-Ferrand, 63003
Service de Médecine Intensive Réanimation Hôpital Michallon - CHU Grenoble Alpes
La Tronche, 38700
Service de Médecine Intensive Réanimation Hôpital Edouard Herriot Hospices Civils de Lyon
Lyon, 69003
Service de Réanimation Chirurgicale Hôpital Edouard Herriot Hospices Civils de Lyon
Lyon, 69003
Service de Médecine Intensive Réanimation Hôpital de la Croix Rousse Hospices Civils de Lyon
Lyon, 69004
Service de Réanimation Chirurgicale Hôpital de la Croix Rousse Hospices Civils de Lyon
Lyon, 69004
Service de réanimation Polyvalente Centre Hospitalier Saint Joseph-Saint Luc
Lyon, 69007
Service de Réanimation Clinique de la Sauvegarde
Lyon, 69009
Service de Réanimation Polyvalente Centre Hospitalier Lyon Sud Hospices Civils de Lyon
Pierre-Bénite, 69310
Service de Réanimation Centre hospitalier Annecy Genevois
Pringy, 74374
Service de Médecine Intensive Réanimation Hôpital Nord - CHU Saint-Etienne
Saint-Priest-en-Jarez, 42055
About this study
Official title: Open Label Randomized Controlled Trial of Ultraprotective Ventilation Without Extracorporeal Circulation in Patients With COVID 19 Pneumonia and Moderate to Severe ARDS
Mortality of COVID-19 pneumonia with acute respiratory distress syndrome (ARDS) is extremely high in preliminary reports amounting to 50-60%. Duration of mechanical ventilation in these patients appears to exceed standard duration of mechanical ventilation in non-COVID-19 ARDS patients, suggesting that COVID-19 patients may be particularly at risk for ventilator-induced lung injury. Treatment of COVID-19 ARDS patients is to date mainly supportive with protective mechanical ventilation (ventilation with low tidal volume (VT) i.e. 6 ml/kg of predicted body weight (PBW) and plateau pressure control below 30 cm H2O).
Mechanical ventilation with VT reduction below 6 ml/kg PBW in ARDS may reduce alveolar strain, driving pressure and hence ventilator-induced lung injury. Investigators recently performed a multicenter pilot study on 34 moderately severe to severe ARDS patients. This study demonstrated that ultraprotective ventilation with ultra-low VT (≤4.2 ml/kg PBW) without extracorporeal circulation may be applied in approximately 2/3 of the patients, with a 4 cmH2O median reduction in driving pressure, at the price of transient episodes of severe acidosis in approximately 1/3 of the patients. Investigators hypothesized that ultraprotective ventilation without extracorporeal circulation may reduce the mortality at day-90 and increase the number of days free from mechanical ventilation (VFD) at day-60, as compared to protective ventilation.
- Conditions
- Acute Respiratory Distress Syndrome, COVID19, Sars-CoV2, Pneumonia
- Being tested
- PROTECTIVE VENTILATION, ULTRAPROTECTIVE VENTILATION
- Keywords
- COVID19, ARDS, MECHANICAL VENTILATION, ULTRAPROTECTIVE VENTILATION
- Medical subject headings
- Respiratory Distress Syndrome, COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROTECTIVE VENTILATIONOther
Protective ventilation with tidal volume 6 mL/kg of predicted body weight further adjusted to keep plateau pressure below 30 cm H2O and pH above 7.20, and PEEP set using the PEEP FiO2 table of the ARMA trial
ULTRAPROTECTIVE VENTILATIONOther
Ultraprotective ventilation with tidal volume reduction down to 4 mL/kg further adjusted to keep plateau pressure below 30 cm H2O and pH above 7.20, and PEEP set using the PEEP FiO2 table of the ARMA trial
| Study group | Role | What they receive |
|---|---|---|
| PROTECTIVE VENTILATION | Active comparator | Protective ventilation with tidal volume 6 mL/kg of predicted body weight Receives: Other: PROTECTIVE VENTILATION |
| ULTRAPROTECTIVE VENTILATION | Experimental | Ultraprotective ventilation with tidal volume reduction down to 4 mL/kg further adjusted to keep plateau pressure below 30 cm H2O and pH above 7.20 Receives: Other: ULTRAPROTECTIVE VENTILATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite score based on all-cause mortality and the number of ventilator free-days (VFD)
For an alive patient at day 90, the score will be built as follow: a value +1 will be given for comparisons to dead patients and alive patients with a lower number of VFD. For comparisons to alive patients with a higher number of VFD a value -1 will be given and in case of identical number of VFD a value 0 will be given. For a dead patient a value -1 will be given for comparisons to alive patients and 0 for comparisons to dead patients. For a given patients the score will correspond to the sum of values resulting to the comparison to all patients of the other group. A higher score indicates a more favorable result.
Measured: Day 90
Secondary outcomes (17)
All-cause mortality (intention to treat)
All-cause mortality with analysis in intention to treat, i.e. each patient will be analyzed in his initial randomization group regardless of whether the allocated strategy was effectively applied or not.
Measured: 90-day after inclusion
Ventilator-free days (VFD)
VFD will be computed as follows from the day of inclusion:
VFD= 0 if the patient dies between inclusion and day 60 VFD = 60-x if the patient is successfully weaned from invasive mechanical ventilation x days after inclusion. Successful weaning from mechanical ventilation is defined by extubation without reintubation within at least 48 hours (or weaning from mechanical ventilation for at least 48 hours in patients with tracheostomy) VFD= 0 if the patient is mechanically ventilated for more than 60 days after inclusion
Measured: day 60 after inclusion
All-cause mortality with per protocol analysis
Per protocol analysis will be carried out by comparing the group of patients in whom median daily tidal volume from inclusion to weaning of deep sedation will be lower of equal to 4.2 ml/kg of predicted body weight to the group of patients in whom median tidal volume from inclusion to weaning of deep sedation will be greater than 4.2 ml/kg of predicted body weight, whatever the patients' initial randomization group.
Weaning of deep sedation is defined by a Richmond Agitation Sedation (RASS) score greater than -3 for at least 48 hours.
Measured: 90-day
Time to successful extubation
Successful extubation is defined by extubation without reintubation within at least 48 hours (or weaning from mechanical ventilation for at least 48 hours in patients with tracheostomy) Data will be right censored at 60 days and death will be taken into account as a competing risk.
Measured: 60 days
Length of hospital stay
Data will be right censored at 90 days and death will be taken into account as a competing risk.
Measured: 90 days
Respiratory parameters assessed daily from inclusion to weaning of deep sedation or 14 days whichever comes first
Weaning of deep sedation is defined by a Richmond Agitation Sedation (RASS) score greater than -3 for at least 48 hours.
Measured: 14 days
Daily sedation dose during the first 14 days of the study
Doses of the following drugs used for deep sedation will be assessed daily: midazolam, propofol and opioid. Opioid dose will be expressed as morphine equivalent with the following conversion factor: 1µg of sufentanil = 10 µg of fentanyl = 1 mg of morphine
Measured: 14 days
Rate of use of rescue therapies
Rescue therapies are any therapy among the following ones: neuromuscular blocking agents, prone position, nitric oxide, recruitment maneuvers, ECMO
Measured: 14 days
Incidence density rate of severe mixed acidosis
Severe mixed acidosis is defined by the association of pH<7.15 and PaCO2>45 mm Hg.
Measured: ICU stay
Incidence density rate of ventilator associated pneumonia
Ventilator associated pneumonia will be defined as any pneumonia acquired under mechanical ventilation after inclusion.
Measured: ICU stay
Incidence density rate of acute cor pulmonale
Acute cor pulmonale is defined by the association of right ventricle dilatation (right ventricle surface / left ventricle surface >0,6) and septal dyskinesia assessed by echocardiography
Measured: ICU stay
Incidence density rate of barotrauma
Barotrauma is defined by any pneumothorax OR pneumomediastinum OR subcutaneous emphysema, OR pneumatocele of more than 2 cm detected on image examinations.
Measured: ICU stay
Incidence density rate of any serious adverse events
Serious adverse event is any life threatening event OR any event resulting in death.
Measured: ICU stay
Cognitive impairment assessed by phone call using the Telephone Montreal Cognitive Assessment (T-MoCA) test
The Telephone Montreal Cognitive Assessment score will be assessed by phone call. The total score ranges from 0 to 30; higher scores being associated to a better outcome.
Measured: Day 365 after inclusion
Quality of life assessed by the RAND 36-Item Health Survey (SF-36) score
The RAND 36-Item Health Survey (SF-36) score will be assessed by phone call. The score ranges from 0 to 100; higher scores being associated to a better outcome.
Measured: Day 365 after inclusion
Post-traumatic stress disorder assessed by the Impact of Event Scale - revised (IES-R) score by phone call
The Impact of Event Scale - revised (IES-R) score will be assessed by phone call. The total score ranges from 0 to 88; higher scores being associated to a worse outcome.
Measured: Day 365 after inclusion
Cost-efficacy ratio of the innovative strategy compared to the reference strategy
The cost-efficacy ratio will be computed as the ratio of cost difference on efficacy difference between the intervention arm and the reference arm. The costs taken into account will be the direct hospitalized costs. The efficacy will be assessed as the number of days alive free from mechanical ventilation.
Measured: Day 90 after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start15 Apr 2020
- Primary completion16 Jun 2022
- Study completion16 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349618
- Sponsor's protocol ID
- 69HCL20_0322
- Acronym
- VT4COVID
- Status last verified
- Dec 2025
- First submitted
- 8 Apr 2020
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Richard JC, Chorfa F, Terzi N, Yonis H, Wallet F, Dupuis C, Argaud L, Delannoy B, Thiery G, Bourdin G, Rimmele T, Muller M, Sigaud F, Rigault G, Joffredo E, Mezidi M, Souweine B, Baboi L, Serrier H, Rabilloud M, Bitker L. Impact of ultra-low tidal volume ventilation on 1-year functional outcome in COVID-19 ARDS patients. A long-term follow-up analysis of a randomized controlled trial. Crit Care. 2026 Jul 14. doi: 10.1186/s13054-026-06195-3. Online ahead of print.
PubMed 42449426Richard JC, Terzi N, Yonis H, Chorfa F, Wallet F, Dupuis C, Argaud L, Delannoy B, Thiery G, Pommier C, Abraham P, Muller M, Sigaud F, Rigault G, Joffredo E, Mezidi M, Souweine B, Baboi L, Serrier H, Rabilloud M, Bitker L; VT4COVID collaborators. Ultra-low tidal volume ventilation for COVID-19-related ARDS in France (VT4COVID): a multicentre, open-label, parallel-group, randomised trial. Lancet Respir Med. 2023 Nov;11(11):991-1002. doi: 10.1016/S2213-2600(23)00221-7. Epub 2023 Jul 12.
PubMed 37453445Richard JC, Yonis H, Bitker L, Roche S, Wallet F, Dupuis C, Serrier H, Argaud L, Thiery G, Delannoy B, Pommier C, Abraham P, Muller M, Aubrun F, Sigaud F, Rigault G, Joffredo E, Mezidi M, Terzi N, Rabilloud M. Open-label randomized controlled trial of ultra-low tidal ventilation without extracorporeal circulation in patients with COVID-19 pneumonia and moderate to severe ARDS: study protocol for the VT4COVID trial. Trials. 2021 Oct 11;22(1):692. doi: 10.1186/s13063-021-05665-z.
PubMed 34635128
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Randomized Controlled Trial of Ultraprotective Ventilation Without Extracorporeal Circulation in Patients With COVID 19 Pneumonia and Moderate to Severe ARDS
- ClinicalTrials.gov ID
- NCT04349618
- Acronym / sponsor ID
- VT4COVID / 69HCL20_0322
- Conditions
- Acute Respiratory Distress Syndrome, COVID19, Sars-CoV2, Pneumonia
- Keywords
- COVID19, ARDS, MECHANICAL VENTILATION, ULTRAPROTECTIVE VENTILATION
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mortality of COVID-19 pneumonia with acute respiratory distress syndrome (ARDS) is extremely high in preliminary reports amounting to 50-60%. Duration of mechanical ventilation in these patients appears to exceed standard duration of mechanical ventilation in non-COVID-19 ARDS patients, suggesting that COVID-19 patients may be particularly at risk for ventilator-induced lung injury. Treatment of COVID-19 ARDS patients is to date mainly supportive with protective mechanical ventilation (ventilation with low tidal volume (VT) i.e. 6 ml/kg of predicted body weight (PBW) and plateau pressure control below 30 cm H2O).
Mechanical ventilation with VT reduction below 6 ml/kg PBW in ARDS may reduce alveolar strain, driving pressure and hence ventilator-induced lung injury. Investigators recently performed a multicenter pilot study on 34 moderately severe to severe ARDS patients. This study demonstrated that ultraprotective ventilation with ultra-low VT (≤4.2 ml/kg PBW) without extracorporeal circulation may be applied in approximately 2/3 of the patients, with a 4 cmH2O median reduction in driving pressure, at the price of transient episodes of severe acidosis in approximately 1/3 of the patients. Investigators hypothesized that ultraprotective ventilation without extracorporeal circulation may reduce the mortality at day-90 and increase the number of days free from mechanical ventilation (VFD) at day-60, as compared to protective ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROTECTIVE VENTILATION | Active comparator | Other: PROTECTIVE VENTILATIONProtective ventilation with tidal volume 6 mL/kg of predicted body weight |
| ULTRAPROTECTIVE VENTILATION | Experimental | Other: ULTRAPROTECTIVE VENTILATIONUltraprotective ventilation with tidal volume reduction down to 4 mL/kg further adjusted to keep plateau pressure below 30 cm H2O and pH above 7.20 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (21 listed)
- Exclusion criteria related to ARDS severity or complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROTECTIVE VENTILATIONProtective ventilation with tidal volume 6 mL/kg of predicted body weight further adjusted to keep plateau pressure below 30 cm H2O and pH above 7.20, and PEEP set using the PEEP FiO2 table of the ARMA trial | Other | PROTECTIVE VENTILATION |
| ULTRAPROTECTIVE VENTILATIONUltraprotective ventilation with tidal volume reduction down to 4 mL/kg further adjusted to keep plateau pressure below 30 cm H2O and pH above 7.20, and PEEP set using the PEEP FiO2 table of the ARMA trial | Other | ULTRAPROTECTIVE VENTILATION |
Primary outcome
A composite score based on all-cause mortality and the number of ventilator free-days (VFD)
Time frame: Day 90
For an alive patient at day 90, the score will be built as follow: a value +1 will be given for comparisons to dead patients and alive patients with a lower number of VFD. For comparisons to alive patients with a higher number of VFD a value -1 will be given and in case of identical number of VFD a value 0 will be given. For a dead patient a value -1 will be given for comparisons to alive patients and 0 for comparisons to dead patients. For a given patients the score will correspond to the sum of values resulting to the comparison to all patients of the other group. A higher score indicates a more favorable result.
17 secondary outcomes
All-cause mortality (intention to treat)
Time frame: 90-day after inclusion
Ventilator-free days (VFD)
Time frame: day 60 after inclusion
All-cause mortality with per protocol analysis
Time frame: 90-day
Time to successful extubation
Time frame: 60 days
Length of hospital stay
Time frame: 90 days
Respiratory parameters assessed daily from inclusion to weaning of deep sedation or 14 days whichever comes first
Time frame: 14 days
Daily sedation dose during the first 14 days of the study
Time frame: 14 days
Rate of use of rescue therapies
Time frame: 14 days
Incidence density rate of severe mixed acidosis
Time frame: ICU stay
Incidence density rate of ventilator associated pneumonia
Time frame: ICU stay
Incidence density rate of acute cor pulmonale
Time frame: ICU stay
Incidence density rate of barotrauma
Time frame: ICU stay
Incidence density rate of any serious adverse events
Time frame: ICU stay
Cognitive impairment assessed by phone call using the Telephone Montreal Cognitive Assessment (T-MoCA) test
Time frame: Day 365 after inclusion
Quality of life assessed by the RAND 36-Item Health Survey (SF-36) score
Time frame: Day 365 after inclusion
Post-traumatic stress disorder assessed by the Impact of Event Scale - revised (IES-R) score by phone call
Time frame: Day 365 after inclusion
Cost-efficacy ratio of the innovative strategy compared to the reference strategy
Time frame: Day 90 after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Derived from this study: PubMed 42449426Richard JC, Chorfa F, Terzi N, Yonis H, Wallet F, Dupuis C, Argaud L, Delannoy B, Thiery G, Bourdin G, Rimmele T, Muller M, Sigaud F, Rigault G, Joffredo E, Mezidi M, Souweine B, Baboi L, Serrier H, Rabilloud M, Bitker L. Impact of ultra-low tidal volume ventilation on 1-year functional outcome in COVID-19 ARDS patients. A long-term follow-up analysis of a randomized controlled trial. Crit Care. 2026 Jul 14. doi: 10.1186/s13054-026-06195-3. Online ahead of print.
- Derived from this study: PubMed 37453445Richard JC, Terzi N, Yonis H, Chorfa F, Wallet F, Dupuis C, Argaud L, Delannoy B, Thiery G, Pommier C, Abraham P, Muller M, Sigaud F, Rigault G, Joffredo E, Mezidi M, Souweine B, Baboi L, Serrier H, Rabilloud M, Bitker L; VT4COVID collaborators. Ultra-low tidal volume ventilation for COVID-19-related ARDS in France (VT4COVID): a multicentre, open-label, parallel-group, randomised trial. Lancet Respir Med. 2023 Nov;11(11):991-1002. doi: 10.1016/S2213-2600(23)00221-7. Epub 2023 Jul 12.
- Derived from this study: PubMed 34635128Richard JC, Yonis H, Bitker L, Roche S, Wallet F, Dupuis C, Serrier H, Argaud L, Thiery G, Delannoy B, Pommier C, Abraham P, Muller M, Aubrun F, Sigaud F, Rigault G, Joffredo E, Mezidi M, Terzi N, Rabilloud M. Open-label randomized controlled trial of ultra-low tidal ventilation without extracorporeal circulation in patients with COVID-19 pneumonia and moderate to severe ARDS: study protocol for the VT4COVID trial. Trials. 2021 Oct 11;22(1):692. doi: 10.1186/s13063-021-05665-z.
- Individual participant dataSharing planned: No
Related trials for Acute Respiratory Distress Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROTECTIVE VENTILATION and ULTRAPROTECTIVE VENTILATION in people with Acute Respiratory Distress Syndrome and COVID19, run by Hospices Civils de Lyon at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite score based on all-cause mortality and the number of ventilator free-days (VFD) (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04349618, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.