Mechanical VentilationART-3pilotNCT02376647
ART-3 Pilot - Driving Pressure Limited Ventilation for Patients Without ARDS (ART3pilot)
A study testing Driving pressure limited ventilation and Conventional ventilation in people with Mechanical Ventilation and Acute Respiratory Distress Syndrome, run by Hospital do Coracao at 1 site in Brazil.
Trial summary
This is a multicenter randomized controlled pilot trial to investigate the feasibility of a driving pressure limited mechanical ventilation strategy compared to a conventional strategy in patients without acute respiratory distress syndrome (ARDS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, 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
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2022to Oct 2024
- 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
- Patients on invasive mechanical ventilation for less than 72 hours and without diagnosis of ARDS, and no perspective of extubation in 24 hours.
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ART-3 Pilot: A Randomized Controlled Trial to Assess the Feasiblity of a Driving Pressure Limited Ventilation vs.Standard Strategy in Patients Without ARDS
This is a multicenter randomized controlled pilot trial to investigate the feasibility of a driving pressure limited mechanical ventilation strategy compared to a conventional strategy in patients without 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 without acute respiratory distress syndrome (ARDS).
Thus, ART-3 pilot is a multicenter randomized controlled trial to assess the feasibility of a driving pressure limited mechanical ventilation strategy compared to a conventional strategy in patients without ARDS. Patients considered to this trial are those in mechanical ventilation for less than 72 hours without diagnosis of ARDS. 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 conventional strategy (tidal volume of 8 mL/kg of predicted body weight). The primary outcome is driving pressure between days 1 and 3.
- Being tested
- Driving pressure limited ventilation, Conventional ventilation
- Keywords
- Patients, ARDS diagnosis
- 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
Investigators will use volume controlled (or pressure support ventilation) and 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). Investigators will not limit plateau pressure in this arm.
Once a daily the investigators will assess the target tidal volume that generates a driving pressure of 13cmH2O. The patient should be sedated and without spontaneous efforts during this assessment.
Conventional ventilationOther
Investigators will use volume controlled or pressure support ventilation, tidal volume ≤8 mL/kg of predicted body weight and plateau pressure limited to 30 cmH2O.The respiratory rate will be titrated to achieve a pH between 7.30 and 7.45 (maximum respiratory rate is 35 breathings per minute).
| Study group | Role | What they receive |
|---|---|---|
| Driving pressure limited ventilation | Experimental | Driving pressure limited ventilation (≤13cmH2O) Receives: Other: Driving pressure limited ventilation |
| Conventional ventilation | Active comparator | Mechanical ventilation with limited tidal volume (8mL/kg of predicted body weight) and plateau pressure (≤30cmH2O) 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
Measured: From Day 1 to Day 3 after randomization
Secondary outcomes (17)
Rate of investigators adering to study procedures
Measured: Days 1 to 7
Rate of driving pressure equal or lower than 13 cmH2O
Measured: Days 1 to 3 after randomization
Mean of positive end expiratory pressure (PEEP) from day 1 to 7
Measured: Days 1 to 7
Mean tidal volume from day 1 to 7
Measured: Days 1 to 7
Mean static compliance of the respiratory system from day 1 to 7
Measured: Days 1 to 7
Mean plateau pressure from day 1 to 7
Measured: Days 1 to 7
Mean driving pressure from day 1 to 7
Measured: Days 1 to 7
Mean respiratory rate from day 1 to 7
Measured: Days 1 to 7
Number of patients with barotrauma
Measured: Days 1 to 7
Mean of severe acidosis (pH <7.1)
Measured: Days 1 to 7
Number of patients with other adverse events
Measured: Days 1 to 7
Lenght of stay in intensive care unit
Measured: Patients will be followed during the period of ICU stay, an expected average of 28 days
Lenght of stay in hospital
Measured: Patients will be followed during the period of hospital stay, an expected average of 28 days
Number of mechanical ventilation free days from day 0 to day 28
Measured: From day 0 to day 28
ICU mortality
Measured: Patients will be followed during the period of hospital stay, an expected average of 28 days
In-hospital mortality
Measured: Patients will be followed during the period of hospital stay, an expected average of 28 days
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 posted3 Mar 2015 (estimated)
- Study startMar 2022 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Why it stopped: No funding obtained so far. Project was halted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Collaborators
- Brazilian Research In Intensive Care Network
- Responsible party
- Sponsor
- Investigators
- Alexandre B Cavalcanti, MD, PhD, Study chair, Hospital do Coração(Heart Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376647
- Sponsor's protocol ID
- ART-3pilot
- Other IDs
- ART-3pilot
- Acronym
- ART-3pilot
- Status last verified
- Sep 2022
- First submitted
- 13 Feb 2015
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ART-3 Pilot: A Randomized Controlled Trial to Assess the Feasiblity of a Driving Pressure Limited Ventilation vs.Standard Strategy in Patients Without ARDS
- ClinicalTrials.gov ID
- NCT02376647
- Acronym / sponsor ID
- ART-3pilot / ART-3pilot
- Keywords
- Patients, ARDS diagnosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding obtained so far. Project was halted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Collaborators
- Brazilian Research In Intensive Care Network
- Study start
- Mar 2022 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 3 Mar 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 a conventional strategy in patients without 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 without acute respiratory distress syndrome (ARDS).
Thus, ART-3 pilot is a multicenter randomized controlled trial to assess the feasibility of a driving pressure limited mechanical ventilation strategy compared to a conventional strategy in patients without ARDS. Patients considered to this trial are those in mechanical ventilation for less than 72 hours without diagnosis of ARDS. 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 conventional strategy (tidal volume of 8 mL/kg of predicted body weight). 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 (≤13cmH2O) |
| Conventional ventilation | Active comparator | Other: Conventional ventilationMechanical ventilation with limited tidal volume (8mL/kg of predicted body weight) and plateau pressure (≤30cmH2O) |
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 for less than 72 hours and without diagnosis of ARDS, and no perspective of extubation in 24 hours.
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 ventilationInvestigators will use volume controlled (or pressure support ventilation) and 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). Investigators will not limit plateau pressure in this arm. Once a daily the investigators will assess the target tidal volume that generates a driving pressure of 13cmH2O. The patient should be sedated and without spontaneous efforts during this assessment. | Other | Driving pressure limited ventilation |
| Conventional ventilationInvestigators will use volume controlled or pressure support ventilation, tidal volume ≤8 mL/kg of predicted body weight and plateau pressure limited to 30 cmH2O.The respiratory rate will be titrated to achieve a pH between 7.30 and 7.45 (maximum respiratory rate is 35 breathings per minute). | Other | Conventional ventilation |
Primary outcome
Mean driving pressure between Day 1 and Day 3
Time frame: From Day 1 to Day 3 after randomization
17 secondary outcomes
Rate of investigators adering to study procedures
Time frame: Days 1 to 7
Rate of driving pressure equal or lower than 13 cmH2O
Time frame: Days 1 to 3 after randomization
Mean of positive end expiratory pressure (PEEP) from day 1 to 7
Time frame: Days 1 to 7
Mean tidal volume from day 1 to 7
Time frame: Days 1 to 7
Mean static compliance of the respiratory system from day 1 to 7
Time frame: Days 1 to 7
Mean plateau pressure from day 1 to 7
Time frame: Days 1 to 7
Mean driving pressure from day 1 to 7
Time frame: Days 1 to 7
Mean respiratory rate from day 1 to 7
Time frame: Days 1 to 7
Number of patients with barotrauma
Time frame: Days 1 to 7
Mean of severe acidosis (pH <7.1)
Time frame: Days 1 to 7
Number of patients with other adverse events
Time frame: Days 1 to 7
Lenght of stay in intensive care unit
Time frame: Patients will be followed during the period of ICU stay, an expected average of 28 days
Lenght of stay in hospital
Time frame: Patients will be followed during the period of hospital stay, an expected average of 28 days
Number of mechanical ventilation free days from day 0 to day 28
Time frame: From day 0 to day 28
ICU mortality
Time frame: Patients will be followed during the period of hospital stay, an expected average of 28 days
In-hospital mortality
Time frame: Patients will be followed during the period of hospital stay, an expected average of 28 days
28-day survival
Time frame: From day 0 to day 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
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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 Coração(Heart Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Driving pressure limited ventilation and Conventional ventilation in people with Mechanical Ventilation and Acute Respiratory Distress Syndrome, run by Hospital do Coracao at 1 site in Brazil.
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: withdrawn, as of the sponsor's last update on 22 Sep 2022. 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 Brazil. 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 was withdrawn before enrolling participants, so there are no results.
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: From 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?
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 22 Sep 2022.