Acute respiratory distress syndrome (ARDS) is a common scenario in intensive care unit. Discussions about it is exponentially growing up due its high mortality rates all over the world and low quality of life among survivors. Mechanical ventilation is recognized to play an important role in treatment of patients with ARDS. However, mechanical ventilation itself has the potential to produce or worsen alveolar injury if inadequate strategies are chosen. Several studies compared different mechanical ventilation strategies in ARDS but the results remain uncertain regarding their influence on survival in patients with ARDS. Thus, this is a multicentric randomized controlled trial, with allocation concealment and intention to treat analysis to investigate if maximum alveolar recruitment maneuver in association to Positive end-expiratory pressure (PEEP) titrated by static compliance of respiratory system (ART strategy) is able to increase 28 days survival in patients with moderate to severe ARDS compared to conventional strategy proposed by the ARDS Clinical Network (ARDSNet strategy). Patients considered to this trial are those in mechanical ventilation with diagnosis of moderate to severe ARDS less than 72hours. Patients included will be randomized to receive ART strategy or ARDSNet strategy and will be followed until hospital discharge, 28 days and 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,013
Maximum alveolar recruitment maneuver in association with PEEP titrated by the static compliance of respiratory system.
Conventional mechanical ventilation strategy.
Hospital do Coracao
São Paulo, São Paulo, Brazil
Survival in 28 days
Survival within 28 days from randomization
Time frame: 28 days
Lenght of ICU stay
Length of hospital stay from randomization to ICU discharge
Time frame: Maximum 6-months
Lenght of hospital stay
Length of hospital stay from randomization to hospital discharge
Time frame: Maximum 6 months
Pneumothorax requiring drainage
We consider as pneumothorax requiring chest tube within 7 days any case that is possibly due to barotrauma, that is, we do not consider cases judged to be clearly caused by invasive procedures such as central venous punction or thoracocentesis.
Time frame: 7 days
Barotrauma
We consider as barotrauma within 7 days any pneumothorax, pneumomediastinum, subcutaneous emphysema or pneumatocele \> 2cm detected on image exams between randomization and 7 days, except those judged to be clearly caused by invasive procedures.
Time frame: 7 days
Days free of mechanical ventilation
Number of days alive and out of mechanical ventilation between randomization and 28 days after randomization.
Time frame: 28 days
ICU survival
Survival at ICU discharge.
Time frame: Maximum 6-months
In-hospital survival
Survival at hospital discharge.
Time frame: Maximum 6-months
6-month survival
Survival within 6 months after randomization
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.