Acute Respiratory Distress SyndromeVT4ARDSNCT02816372
Ultra Protective Ventilation Without Extracorporeal Circulation in Severe ARDS Patients (VT4ARDS)
A study testing Tidal volume reduction to 4 ml/kg Predicted Body Weight (PBW) in people with Acute Respiratory Distress Syndrome, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Despite the use of protective ventilation, neuromuscular blocking agent and prone position, ARDS mortality remains high (30%-50%) in observational studies, and pneumothorax rate in randomized controlled trial remains stable (10%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Tidal volume reduction to 4 ml/kg Predicted Body Weight (PBW)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to 14 Jun 2018
- 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
- invasive mechanical ventilation
- ARDS (Berlin definition) with PaO2/FiO2 ratio ≤ 150 mm Hg
Who cannot join
- Age below 18 year
- planned duration of invasive mechanical ventilation < 48 hours
- ARDS criteria present for more than 24 hours
- known or suspected intracranial hypertension
- known or suspected COPD
- chronic respiratory failure under long term oxygen or non-invasive ventilation
Show all 20Show fewer
- pneumothorax or broncho-pleural fistula
- morbid obesity with body weight >1 kg/cm height
- sickle cell disease
- recent bone marrow transplantation, aplasia following chemotherapy
- burn injury on more than 30% of body surface
- severe hepatic cirrhosis (Child-Pugh score C)
- extracorporeal circulation life support
- pregnancy
- advance directives to withhold or withdraw life-sustaining treatment
- previous inclusion in present study
- patient under an exclusion period following inclusion in another biomedical study
- patient deprived of freedom, minor, subject 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
Trial locations and contacts
1 site in 1 country.
About this study
Despite the use of protective ventilation, neuromuscular blocking agent and prone position, ARDS mortality remains high (30%-50%) in observational studies, and pneumothorax rate in randomized controlled trial remains stable (10%). The driving pressure (the ratio of tidal volume over respiratory system compliance) has recently been strongly associated with ARDS mortality, suggesting that tidal volume reduction below 6ml/kg may offer mortality benefit. While extracorporeal CO2 removal technique are currently under investigation in association with tidal volume reduction
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Tidal volume reduction to 4 ml/kg Predicted Body Weight (PBW)
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tidal volume reduction to 4 ml/kg Predicted Body Weight (PBW)Other
Tidal volume reduction to 4 ml/kg predicted body weight from inclusion to weaning PEEP trial
| Study group | Role | What they receive |
|---|---|---|
| Tidal volume 4 ml/kg Predicted Body Weight (PBW) | Experimental | Not described Receives: Other: Tidal volume reduction to 4 ml/kg Predicted Body Weight (PBW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in driving pressure
Driving pressure is the difference between total respiratory system plateau pressure minus total positive end-expiratory pressure (PEEP)
Measured: Baseline and 24 hours following inclusion
Secondary outcomes (3)
Rate of patients who achieved tidal volume reduction equal to 4 ml/kg predicted body weight
Measured: 48 hours following inclusion
Rate of pneumothorax
Measured: Day 90
Change in right ventricule/left ventricule area
Echographic measurement of right ventricule/left ventricule
Measured: Baseline and 24 hours following inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startOct 2016
- Primary completion14 Jun 2018
- Study completion14 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 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
- NCT02816372
- Sponsor's protocol ID
- 69HCL16_0082
- Other IDs
- 2016-A00503-48
- Acronym
- VT4ARDS
- Status last verified
- Aug 2025
- First submitted
- 24 Jun 2016
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Richard JC, Marque S, Gros A, Muller M, Prat G, Beduneau G, Quenot JP, Dellamonica J, Tapponnier R, Soum E, Bitker L, Richecoeur J; REVA research network. Feasibility and safety of ultra-low tidal volume ventilation without extracorporeal circulation in moderately severe and severe ARDS patients. Intensive Care Med. 2019 Nov;45(11):1590-1598. doi: 10.1007/s00134-019-05776-x. Epub 2019 Sep 23.
PubMed 31549225
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra Protective Ventilation Without Extracorporeal Circulation in Severe ARDS Patients (VT4ARDS)
- ClinicalTrials.gov ID
- NCT02816372
- Acronym / sponsor ID
- VT4ARDS / 69HCL16_0082
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 14 Jun 2018 (actual)
- Study completion
- 14 Jun 2018 (actual)
- First posted
- 28 Jun 2016 (estimated)
- 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.
Despite the use of protective ventilation, neuromuscular blocking agent and prone position, ARDS mortality remains high (30%-50%) in observational studies, and pneumothorax rate in randomized controlled trial remains stable (10%). The driving pressure (the ratio of tidal volume over respiratory system compliance) has recently been strongly associated with ARDS mortality, suggesting that tidal volume reduction below 6ml/kg may offer mortality benefit. While extracorporeal CO2 removal technique are currently under investigation in association with tidal volume reduction
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tidal volume 4 ml/kg Predicted Body Weight (PBW) | Experimental | Other: Tidal volume reduction to 4 ml/kg Predicted Body Weight (PBW) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- invasive mechanical ventilation
- ARDS (Berlin definition) with PaO2/FiO2 ratio ≤ 150 mm Hg
Key exclusion criteria (20 listed)
- Age below 18 year
- planned duration of invasive mechanical ventilation < 48 hours
- ARDS criteria present for more than 24 hours
- known or suspected intracranial hypertension
- known or suspected COPD
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 |
|---|---|---|
| Tidal volume reduction to 4 ml/kg Predicted Body Weight (PBW)Tidal volume reduction to 4 ml/kg predicted body weight from inclusion to weaning PEEP trial | Other | Tidal volume 4 ml/kg Predicted Body Weight (PBW) |
Primary outcome
Change in driving pressure
Time frame: Baseline and 24 hours following inclusion
Driving pressure is the difference between total respiratory system plateau pressure minus total positive end-expiratory pressure (PEEP)
3 secondary outcomes
Rate of patients who achieved tidal volume reduction equal to 4 ml/kg predicted body weight
Time frame: 48 hours following inclusion
Rate of pneumothorax
Time frame: Day 90
Change in right ventricule/left ventricule area
Time frame: Baseline and 24 hours following 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 8 Aug 2025.
- Results publication: PubMed 31549225Richard JC, Marque S, Gros A, Muller M, Prat G, Beduneau G, Quenot JP, Dellamonica J, Tapponnier R, Soum E, Bitker L, Richecoeur J; REVA research network. Feasibility and safety of ultra-low tidal volume ventilation without extracorporeal circulation in moderately severe and severe ARDS patients. Intensive Care Med. 2019 Nov;45(11):1590-1598. doi: 10.1007/s00134-019-05776-x. Epub 2019 Sep 23.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tidal volume reduction to 4 ml/kg Predicted Body Weight (PBW) in people with Acute Respiratory Distress Syndrome, run by Hospices Civils de Lyon at 1 site 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 2 inclusion and 20 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 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in driving pressure (time frame: Baseline and 24 hours following inclusion). 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 NCT02816372, which also lists 1 linked publication.
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 8 Aug 2025.