Acute Respiratory Distress SyndromePhase 1/2ART2pilotNCT02365038
ART-2 Pilot - Driving Pressure Limited Ventilation for Patients With ARDS
A Phase 1/2 study testing Driving pressure limited ventilation and Conventional ventilation in people with Acute Respiratory Distress Syndrome, run by Hospital do Coracao.
Trial summary
This is a multicenter randomized controlled pilot trial to investigate the feasibility of a driving pressure limited mechanical ventilation strategy compared to the ARDS Clinical Network strategy (conventional strategy) in patients with acute respiratory distress syndrome (ARDS). 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?
- Driving pressure limited ventilation and Conventional ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 12 Jun 2015to 1 Jul 2017
- Phase
- Phase 1/2
- 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
- Patients on invasive mechanical ventilation with diagnosis of ARDS of less than 72 hours duration.
Who cannot join
- Less than 18 years old.
- Presence of any contraindication to hypercapnia as suspected or confirmed intracranial hypertension or recent (<7 days) acute coronary syndrome.
- Patients in which a high probability of death within 24 hours is anticipated.
- Patients under exclusive palliative care.
About this study
Official title: ART-2 Pilot: A Controlled, Randomized Trial to Assess the Feasiblity of a Driving Pressure Limited Ventilation vs. Standard Strategy (ARDSNet) in Patients With ARDS
This is a multicenter randomized controlled pilot trial to investigate the feasibility of a driving pressure limited mechanical ventilation strategy compared to the ARDS Clinical Network strategy (conventional strategy) in patients with acute respiratory distress syndrome (ARDS).
Read the detailed description
Mechanical ventilation has the potential to produce or worsen alveolar injury. Driving pressure is the difference between plateau pressure and PEEP. Evidence from observational studies suggests that elevated driving pressure is the main independent determinant of ventilator-induced lung injury, however clinical trials are needed to establish whether targeting low driving pressures can improve clinical outcomes in patients with acute respiratory distress syndrome (ARDS). Thus, ART2pilot is a multicenter randomized controlled trial to assess the feasibility of a driving pressure limited mechanical ventilation strategy compared to the ARDS Clinical Network strategy (conventional strategy) in patients with ARDS. Patients considered to this trial are those in mechanical ventilation with diagnosis of ARDS of less than 72 hours duration. We will exclude patients with less than 18 years old; contraindication to hypercapnia such as intracranial hypertension or recent acute coronary syndrome; patients in which a high probability of death within 24 hours is anticipated and patients under exclusive palliative care. Eligible patients will be randomized to the driving pressure limited ventilation strategy or ARDSNet strategy. The primary outcome is driving pressure between days 1 and 3.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Driving pressure limited ventilation, Conventional ventilation
- 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.
Driving pressure limited ventilationOther
We will use volume controlled ventilation or pressure support in the weaning phase. We will adjust tidal volume between 3 and 8 mL/Kg of predicted body weight in order to achieve a driving pressure of 13 cmH2O. The respiratory rate will be titrated to achieve a pH between 7.30 and 7.45 (maximum respiratory rate is 50 breathings per minute). We will not limit plateau pressure in this arm.
Conventional ventilationOther
Also called ARDSNet strategy
ARDSNet Strategy: conventional mechanical ventilation strategy with tidal volume between 4 and 6 mL/kg of predicted body weight and plateau pressure limited to 30 cmH2O.
| Study group | Role | What they receive |
|---|---|---|
| Driving pressure limited ventilation | Experimental | Driving pressure limited ventilation Receives: Other: Driving pressure limited ventilation |
| Conventional ventilation | Active comparator | Mechanical ventilation as proposed in the ARDSNet protocol. Receives: Other: Conventional ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean driving pressure between day 1 and day 3
Driving pressure is the difference between plateau pressure and PEEP. It will be measured every morning in patients without spontaneous efforts. As every patients will have up to three measurements, we will consider the mean driving pressure for each patient.
Measured: Day 1 to Day 3 after randomization
Secondary outcomes (17)
Adherence to study procedures: daily adjustement of driving pressure in experimental group and tidal volume in the control group
Measured: Days 1 to 7
Rate of driving pressure equal or lower than 13cmH2O
Measured: Days 1 to 3 after randomization
Mean PEEP from day 1 to 7
Measured: Days 1 to 7
Mean tidal volume from day 1 to day 7
Measured: Days 1 to 7
Mean static compliance of the respiratory system from day 1 to day 7
Measured: Days 1 to 7
Mean plateau pressure from day 1 to day 7
Measured: Days 1 to 7
Mean driving pressure from day 1 to day 7
Measured: Days 1 to 7
Mean respiratory rate from day 1 to day 7
Measured: Days 1 to 7
Barotrauma
Measured: Days 1 to 7
Severe acidosis (pH <7.1)
Measured: Days 1 to 7
Other adverse events
Measured: Days 1 to 7
Length of stay in intensive care unit
Measured: ICU stay
Length of stay in hospital
Measured: In-hospital stay
Mechanical ventilation free days from day 0 to day 28
Measured: From day 0 to day 28
ICU mortality
Measured: ICU stay
In-hospital mortality
Measured: Hospital stay
28-day survival
Measured: From day 0 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 posted18 Feb 2015 (estimated)
- Study start12 Jun 2015
- Primary completion25 Feb 2017
- Study completion1 Jul 2017
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre B Cavalcanti, MD, PhD, Study chair, Hospital do Coracao (Heart Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365038
- Sponsor's protocol ID
- ART2pilot
- Acronym
- ART2pilot
- Status last verified
- Feb 2015
- First submitted
- 6 Feb 2015
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Pereira Romano ML, Maia IS, Laranjeira LN, Damiani LP, Paisani DM, Borges MC, Dantas BG, Caser EB, Victorino JA, Filho WO, Amato MBP, Cavalcanti AB. Driving Pressure-limited Strategy for Patients with Acute Respiratory Distress Syndrome. A Pilot Randomized Clinical Trial. Ann Am Thorac Soc. 2020 May;17(5):596-604. doi: 10.1513/AnnalsATS.201907-506OC.
PubMed 32069068
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ART-2 Pilot: A Controlled, Randomized Trial to Assess the Feasiblity of a Driving Pressure Limited Ventilation vs. Standard Strategy (ARDSNet) in Patients With ARDS
- ClinicalTrials.gov ID
- NCT02365038
- Acronym / sponsor ID
- ART2pilot / ART2pilot
- Conditions
- Acute Respiratory Distress Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Study start
- 12 Jun 2015 (actual)
- Primary completion
- 25 Feb 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 18 Feb 2015 (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.
This is a multicenter randomized controlled pilot trial to investigate the feasibility of a driving pressure limited mechanical ventilation strategy compared to the ARDS Clinical Network strategy (conventional strategy) in patients with acute respiratory distress syndrome (ARDS).
Detailed description
Mechanical ventilation has the potential to produce or worsen alveolar injury. Driving pressure is the difference between plateau pressure and PEEP. Evidence from observational studies suggests that elevated driving pressure is the main independent determinant of ventilator-induced lung injury, however clinical trials are needed to establish whether targeting low driving pressures can improve clinical outcomes in patients with acute respiratory distress syndrome (ARDS). Thus, ART2pilot is a multicenter randomized controlled trial to assess the feasibility of a driving pressure limited mechanical ventilation strategy compared to the ARDS Clinical Network strategy (conventional strategy) in patients with ARDS. Patients considered to this trial are those in mechanical ventilation with diagnosis of ARDS of less than 72 hours duration. We will exclude patients with less than 18 years old; contraindication to hypercapnia such as intracranial hypertension or recent acute coronary syndrome; patients in which a high probability of death within 24 hours is anticipated and patients under exclusive palliative care. Eligible patients will be randomized to the driving pressure limited ventilation strategy or ARDSNet strategy. The primary outcome is driving pressure between days 1 and 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Driving pressure limited ventilation | Experimental | Other: Driving pressure limited ventilationDriving pressure limited ventilation |
| Conventional ventilation | Active comparator | Other: Conventional ventilationMechanical ventilation as proposed in the ARDSNet protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients on invasive mechanical ventilation with diagnosis of ARDS of less than 72 hours duration.
Key exclusion criteria (4 listed)
- Less than 18 years old.
- Presence of any contraindication to hypercapnia as suspected or confirmed intracranial hypertension or recent (<7 days) acute coronary syndrome.
- Patients in which a high probability of death within 24 hours is anticipated.
- Patients under exclusive palliative care.
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 |
|---|---|---|
| Driving pressure limited ventilationWe will use volume controlled ventilation or pressure support in the weaning phase. We will adjust tidal volume between 3 and 8 mL/Kg of predicted body weight in order to achieve a driving pressure of 13 cmH2O. The respiratory rate will be titrated to achieve a pH between 7.30 and 7.45 (maximum respiratory rate is 50 breathings per minute). We will not limit plateau pressure in this arm. | Other | Driving pressure limited ventilation |
| Conventional ventilationAlso: ARDSNet strategyARDSNet Strategy: conventional mechanical ventilation strategy with tidal volume between 4 and 6 mL/kg of predicted body weight and plateau pressure limited to 30 cmH2O. | Other | Conventional ventilation |
Primary outcome
Mean driving pressure between day 1 and day 3
Time frame: Day 1 to Day 3 after randomization
Driving pressure is the difference between plateau pressure and PEEP. It will be measured every morning in patients without spontaneous efforts. As every patients will have up to three measurements, we will consider the mean driving pressure for each patient.
17 secondary outcomes
Adherence to study procedures: daily adjustement of driving pressure in experimental group and tidal volume in the control group
Time frame: Days 1 to 7
Rate of driving pressure equal or lower than 13cmH2O
Time frame: Days 1 to 3 after randomization
Mean PEEP from day 1 to 7
Time frame: Days 1 to 7
Mean tidal volume from day 1 to day 7
Time frame: Days 1 to 7
Mean static compliance of the respiratory system from day 1 to day 7
Time frame: Days 1 to 7
Mean plateau pressure from day 1 to day 7
Time frame: Days 1 to 7
Mean driving pressure from day 1 to day 7
Time frame: Days 1 to 7
Mean respiratory rate from day 1 to day 7
Time frame: Days 1 to 7
Barotrauma
Time frame: Days 1 to 7
Severe acidosis (pH <7.1)
Time frame: Days 1 to 7
Other adverse events
Time frame: Days 1 to 7
Length of stay in intensive care unit
Time frame: ICU stay
Length of stay in hospital
Time frame: In-hospital stay
Mechanical ventilation free days from day 0 to day 28
Time frame: From day 0 to day 28
ICU mortality
Time frame: ICU stay
In-hospital mortality
Time frame: Hospital stay
28-day survival
Time frame: From day 0 to day 28
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 28 Jul 2021.
- Derived from this study: PubMed 32069068Pereira Romano ML, Maia IS, Laranjeira LN, Damiani LP, Paisani DM, Borges MC, Dantas BG, Caser EB, Victorino JA, Filho WO, Amato MBP, Cavalcanti AB. Driving Pressure-limited Strategy for Patients with Acute Respiratory Distress Syndrome. A Pilot Randomized Clinical Trial. Ann Am Thorac Soc. 2020 May;17(5):596-604. doi: 10.1513/AnnalsATS.201907-506OC.
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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.
Alexandre B Cavalcanti, MD, PhD study chair
Hospital do Coracao (Heart Hospital)
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Driving pressure limited ventilation and Conventional ventilation in people with Acute Respiratory Distress Syndrome, run by Hospital do Coracao.
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 1 inclusion and 4 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 28 Jul 2021. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean driving pressure between day 1 and day 3 (time frame: Day 1 to Day 3 after randomization). 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 NCT02365038, 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 28 Jul 2021.