Acute Respiratory Distress Syndrome ARDSDRIVENTNCT06322758
Driving Pressure-guided Tidal Volume Ventilation in the Acute Respiratory Distress Syndrome
A study testing Tidal volume customization in the acute respiratory distress syndrome in people with Acute Respiratory Distress Syndrome ARDS, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Acute respiratory distress syndrome (ARDS) is associated with high mortality, some of which can be attributed to ventilator-induced lung injury (VILI) when artificial ventilation is not customized to the severity of lung injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome ARDS
- What is being tested?
- Tidal volume customization in the acute respiratory distress syndrome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age > 18 years
- Invasive mechanical ventilation
- Criteria for ARDS according to Berlin definition:
- Bilateral infiltrates not fully explained by effusions, lobar/lung collapse, or nodules;
- PaO2/FiO2 of 300 or less measured with a PEEP of at least 5 cm H2O
- Respiratory failure not fully explained by cardiac failure or fluid overload These criteria must be observed for less than 72h
- Affiliation to the social security system
- Written consent obtained from the patients (from a support person, family member or a close relative if the patient is not able to expressing and sign consent) or inclusion without initial consent in case of emergency, if the patient is not able to express his/her consent and in the absence of support person, family member or a close relative
Who cannot join
- Known pregnancy
- Lung transplantation
- Evident significant decrease in chest wall compliance (e.g., abdominal compartment syndrome)
- Moribund patient not expected to survive 24 hours
- Presence of an advanced directive to withhold life-sustaining treatment or decision to withhold life-sustaining treatment
- Chronic respiratory disease requiring home oxygen therapy or ventilation
Show all 10Show fewer
- ECMO before inclusion
- Pneumothorax
- Enrollment in an interventional ARDS trial with direct impact on VT
- Subject deprived of freedom, subject under a legal protective measure (guardianship/curatorship)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Driving Pressure-guided Tidal Volume Ventilation in the Acute Respiratory Distress Syndrome: a Prospective, Multicenter, Randomized, Controlled, Open-label, Phase III Trial
Acute respiratory distress syndrome (ARDS) is associated with high mortality, some of which can be attributed to ventilator-induced lung injury (VILI) when artificial ventilation is not customized to the severity of lung injury. As ARDS is characterized by a decrease in aerated lung volume, reducing tidal volume (VT) from 12 to 6 mL/kg of predicted body weight (PBW) was shown to improve survival more than 20 years ago. Since then, the VT has been normalized to the PBW, meaning to the theoretical lung size (before the disease), rather than tailored to the severity of lung injury, i.e., to the size of aerated lung volume. During ARDS, the aerated lung volume is correlated to the respiratory system compliance (Crs). The driving pressure (ΔP), defined as the difference between the plateau pressure and the positive end expiratory pressure, represents the ratio between the VT and the Crs. Therefore, the ΔP normalizes the VT to a surrogate of the aerated lung available for ventilation of the diseased lung, rather than to the theoretical lung size of the healthy lung, and thus represents more accurately the actual strain applied to the lungs. In a post hoc analysis of 9 randomized controlled trials, Amato et al. found that higher ΔP was a better predictor of mortality than higher VT, with an increased risk of death when the ΔP > 14 cm H2O. These findings have been confirmed in subsequent meta-analysis and large-scale observational data. In a prospective study including 50 patients, the investigators showed that a ΔPguided ventilation strategy targeting a ΔP between 12 and 14 cm H2O significantly reduced the mechanical power, a surrogate for the risk of VILI, compared to a conventional PBW-guided ventilation. In the present study, the investigators hypothesize that the physiological individualization of ventilation (ΔP-guided VT) may improve the outcome of patients with ARDS compared to traditional anthropometrical adjustment (PBW-guided VT)
- Conditions
- Acute Respiratory Distress Syndrome ARDS
- Being tested
- Tidal volume customization in the acute respiratory distress syndrome
- Keywords
- Acute respiratory distress syndrome (ARDS), ventilator-induced lung injury (VILI), respiratory system compliance (Crs), tidal volume (VT), driving pressure (ΔP), predicted body weight (PBW)
- Medical subject headings
- Respiratory Distress Syndrome, Ventilator-Induced Lung Injury, Acrocephalosyndactylia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tidal volume customization in the acute respiratory distress syndromeOther
During volume assist control ventilation, the VT will be adjusted in supine position to target a 12 ≤ ΔP ≤ 14 cm H2O. The allowed minimal and maximal values of VT are consistent with usual practices reported in large observational studies 4 and 10 mL/kg of PBW, respectively, while keeping a plateau pressure below 30 cm H2O. The respiratory rate will then be adjusted to meet the pH target
| Study group | Role | What they receive |
|---|---|---|
| ΔP-guided VT group | Experimental | During volume assist control ventilation, the VT will be adjusted in supine position to target a 12 ≤ ΔP ≤ 14 cm H2O. The allowed minimal and maximal values of VT are consistent with usual practices reported in large observational studies 4 and 10 mL/kg of PBW, respectively, while keeping a plateau pressure below 30 cm H2O. The respiratory rate will then be adjusted to meet the pH target Receives: Other: Tidal volume customization in the acute respiratory distress syndrome |
| PBW-guided VT group | Active comparator | The VT will be kept at 6 mL/kg of PBW. If the plateau pressure threshold is reached (30 cm H2O), the VT will be decreased down to a minimal value of 4 mL/kg of PBW. Receives: Other: Tidal volume customization in the acute respiratory distress syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
The primary endpoint is a ranked composite score that prioritizes 28-day mortality, followed by days free from mechanical ventilation through day 28 for the survivors. Thus, the score is calculated in such a manner that death constitutes a worse outcome than fewer days off the ventilator.
Measured: 28 days
Number of days free from mechanical ventilation
The primary endpoint is a ranked composite score that prioritizes 28-day mortality, followed by days free from mechanical ventilation through day 28 for the survivors. Thus, the score is calculated in such a manner that death constitutes a worse outcome than fewer days off the ventilator.
Measured: 28 days
Secondary outcomes (17)
Ventilator parameters
Measured: up to Day 7
Arterial blood gases
Arterial blood gases (pH, PaO2, PaCO2, HCO3-), recorded in supine position between 6:00 and 12:00 a.m. once a day up to day 7
Measured: up to Day 7
Mortality
ICU mortality and hospital mortality
Measured: Day-28, Day 90
Number of days alive without ventilation
Number of days alive without ventilation between randomization and day 28;
Measured: Up to Day 28
Sequential Organ Failure Assessment score (SOFA)
SOFA score
Measured: Day 1, Day 3 and Day 7
Number of days alive without catecholamine
Number of days alive without catecholamine between randomization and day 28, assessed as a hierarchical endpoint prioritized on 28-day mortality;
Measured: Up to Day 28
Number of days alive without continuous sedation
Number of days alive without continuous sedation between randomization and day 28, assessed as a hierarchical endpoint prioritized on 28-day mortality
Measured: Up to Day 28
Number of days alive without neuromuscular blockers
Number of days alive without neuromuscular blockers between randomization and day 28, assessed as a hierarchical endpoint prioritized on 28-day mortality;
Measured: UP to Day 28
Number of prone position sessions
Number of prone position sessions
Measured: Up to Day 28
Use of rescue procedures: inhaled nitric oxide, almitrine, ECMO, ECCO2R
Use of rescue procedures: inhaled nitric oxide, almitrine, ECMO, ECCO2R
Measured: Up to Day 28
Occurrence of ventilator-associated pneumothorax
Occurrence of ventilator-associated pneumothorax between randomization and day 28;
Measured: Up to Day 28
Time to pressure support ventilation;
Time between randomization and transition to pressure support ventilation;
Measured: Up to Day 28
Duration of weaning unreadiness
Duration of weaning unreadiness measured as the time between randomization and initiation of weaning from mechanical ventilation, defined as the day of the first spontaneous breathing trial;
Measured: Up to Day 28
Duration of weaning
Duration of weaning, defined as the time between the first spontaneous breathing trial and successful extubation
Measured: Up to day 28
The rate of tracheostomy
The rate of tracheostomy
Measured: Up to Day 28
Total duration of mechanical ventilation
Total duration of mechanical ventilation, from intubation to successful extubation, defined as an extubation not followed by reintubation or death within the next 7 days;
Measured: up to Day 7
Length of stay
Length of stay in the ICU and in hospital;
Measured: up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome ARDSStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Model description
- comparing ΔP-guided VT to traditional PBW-guided VT during mechanical ventilation of patients with ARDS.
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322758
- Sponsor's protocol ID
- APHP230851
- Acronym
- DRIVENT
- Status last verified
- Nov 2023
- First submitted
- 14 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving Pressure-guided Tidal Volume Ventilation in the Acute Respiratory Distress Syndrome: a Prospective, Multicenter, Randomized, Controlled, Open-label, Phase III Trial
- ClinicalTrials.gov ID
- NCT06322758
- Acronym / sponsor ID
- DRIVENT / APHP230851
- Conditions
- Acute Respiratory Distress Syndrome ARDS
- Keywords
- Acute respiratory distress syndrome (ARDS), ventilator-induced lung injury (VILI), respiratory system compliance (Crs), tidal volume (VT), driving pressure (ΔP), predicted body weight (PBW)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 Mar 2024 (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.
Acute respiratory distress syndrome (ARDS) is associated with high mortality, some of which can be attributed to ventilator-induced lung injury (VILI) when artificial ventilation is not customized to the severity of lung injury. As ARDS is characterized by a decrease in aerated lung volume, reducing tidal volume (VT) from 12 to 6 mL/kg of predicted body weight (PBW) was shown to improve survival more than 20 years ago. Since then, the VT has been normalized to the PBW, meaning to the theoretical lung size (before the disease), rather than tailored to the severity of lung injury, i.e., to the size of aerated lung volume. During ARDS, the aerated lung volume is correlated to the respiratory system compliance (Crs). The driving pressure (ΔP), defined as the difference between the plateau pressure and the positive end expiratory pressure, represents the ratio between the VT and the Crs. Therefore, the ΔP normalizes the VT to a surrogate of the aerated lung available for ventilation of the diseased lung, rather than to the theoretical lung size of the healthy lung, and thus represents more accurately the actual strain applied to the lungs. In a post hoc analysis of 9 randomized controlled trials, Amato et al. found that higher ΔP was a better predictor of mortality than higher VT, with an increased risk of death when the ΔP > 14 cm H2O. These findings have been confirmed in subsequent meta-analysis and large-scale observational data. In a prospective study including 50 patients, the investigators showed that a ΔPguided ventilation strategy targeting a ΔP between 12 and 14 cm H2O significantly reduced the mechanical power, a surrogate for the risk of VILI, compared to a conventional PBW-guided ventilation. In the present study, the investigators hypothesize that the physiological individualization of ventilation (ΔP-guided VT) may improve the outcome of patients with ARDS compared to traditional anthropometrical adjustment (PBW-guided VT)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- comparing ΔP-guided VT to traditional PBW-guided VT during mechanical ventilation of patients with ARDS.
| Arm | Type | Receives |
|---|---|---|
| ΔP-guided VT group | Experimental | Other: Tidal volume customization in the acute respiratory distress syndromeDuring volume assist control ventilation, the VT will be adjusted in supine position to target a 12 ≤ ΔP ≤ 14 cm H2O. The allowed minimal and maximal values of VT are consistent with usual practices reported in large observational studies 4 and 10 mL/kg of PBW, respectively, while keeping a plateau pressure below 30 cm H2O. The respiratory rate will then be adjusted to meet the pH target |
| PBW-guided VT group | Active comparator | Other: Tidal volume customization in the acute respiratory distress syndromeThe VT will be kept at 6 mL/kg of PBW. If the plateau pressure threshold is reached (30 cm H2O), the VT will be decreased down to a minimal value of 4 mL/kg of PBW. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years
- Invasive mechanical ventilation
- Criteria for ARDS according to Berlin definition:
- Bilateral infiltrates not fully explained by effusions, lobar/lung collapse, or nodules;
- PaO2/FiO2 of 300 or less measured with a PEEP of at least 5 cm H2O
Key exclusion criteria (10 listed)
- Known pregnancy
- Lung transplantation
- Evident significant decrease in chest wall compliance (e.g., abdominal compartment syndrome)
- Moribund patient not expected to survive 24 hours
- Presence of an advanced directive to withhold life-sustaining treatment or decision to withhold life-sustaining treatment
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 customization in the acute respiratory distress syndromeDuring volume assist control ventilation, the VT will be adjusted in supine position to target a 12 ≤ ΔP ≤ 14 cm H2O. The allowed minimal and maximal values of VT are consistent with usual practices reported in large observational studies 4 and 10 mL/kg of PBW, respectively, while keeping a plateau pressure below 30 cm H2O. The respiratory rate will then be adjusted to meet the pH target | Other | PBW-guided VT group, ΔP-guided VT group |
Primary outcome
Mortality
Time frame: 28 days
The primary endpoint is a ranked composite score that prioritizes 28-day mortality, followed by days free from mechanical ventilation through day 28 for the survivors. Thus, the score is calculated in such a manner that death constitutes a worse outcome than fewer days off the ventilator.
Number of days free from mechanical ventilation
Time frame: 28 days
The primary endpoint is a ranked composite score that prioritizes 28-day mortality, followed by days free from mechanical ventilation through day 28 for the survivors. Thus, the score is calculated in such a manner that death constitutes a worse outcome than fewer days off the ventilator.
17 secondary outcomes
Ventilator parameters
Time frame: up to Day 7
Arterial blood gases
Time frame: up to Day 7
Mortality
Time frame: Day-28, Day 90
Number of days alive without ventilation
Time frame: Up to Day 28
Sequential Organ Failure Assessment score (SOFA)
Time frame: Day 1, Day 3 and Day 7
Number of days alive without catecholamine
Time frame: Up to Day 28
Number of days alive without continuous sedation
Time frame: Up to Day 28
Number of days alive without neuromuscular blockers
Time frame: UP to Day 28
Number of prone position sessions
Time frame: Up to Day 28
Use of rescue procedures: inhaled nitric oxide, almitrine, ECMO, ECCO2R
Time frame: Up to Day 28
Occurrence of ventilator-associated pneumothorax
Time frame: Up to Day 28
Time to pressure support ventilation;
Time frame: Up to Day 28
Duration of weaning unreadiness
Time frame: Up to Day 28
Duration of weaning
Time frame: Up to day 28
The rate of tracheostomy
Time frame: Up to Day 28
Total duration of mechanical ventilation
Time frame: up to Day 7
Length of stay
Time frame: up to Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Tidal volume customization in the acute respiratory distress syndrome in people with Acute Respiratory Distress Syndrome ARDS, run by Assistance Publique - Hôpitaux de Paris.
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 8 inclusion and 10 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: opening soon, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume CARTEAUX, Pr (+33 (0)1 49 81 43 85, guillaume.carteaux@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2024.