ART-2 Pilot - Driving Pressure Limited Ventilation for Patients With ARDS
- Conditions
- Acute Respiratory Distress Syndrome
- Interventions
- Other: Driving pressure limited ventilationOther: Conventional ventilation
- Registration Number
- NCT02365038
- Lead Sponsor
- Hospital do Coracao
- Brief 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Driving pressure limited ventilation Driving pressure limited ventilation Driving pressure limited ventilation Conventional ventilation Conventional ventilation Mechanical ventilation as proposed in the ARDSNet protocol.
- Primary Outcome Measures
Name Time Method Mean driving pressure between day 1 and day 3 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.
- Secondary Outcome Measures
Name Time Method In-hospital mortality Hospital stay Adherence to study procedures: daily adjustement of driving pressure in experimental group and tidal volume in the control group Days 1 to 7 Mean plateau pressure from day 1 to day 7 Days 1 to 7 Mean driving pressure from day 1 to day 7 Days 1 to 7 Mean respiratory rate from day 1 to day 7 Days 1 to 7 Barotrauma Days 1 to 7 Mean PEEP from day 1 to 7 Days 1 to 7 Mean tidal volume from day 1 to day 7 Days 1 to 7 Length of stay in hospital In-hospital stay Mechanical ventilation free days from day 0 to day 28 From day 0 to day 28 28-day survival From day 0 to day 28 Other adverse events Days 1 to 7 Rate of driving pressure equal or lower than 13cmH2O Days 1 to 3 after randomization Mean static compliance of the respiratory system from day 1 to day 7 Days 1 to 7 Severe acidosis (pH <7.1) Days 1 to 7 Length of stay in intensive care unit ICU stay ICU mortality ICU stay