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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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.
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).
Alexandre Biasi Cavalcanti
São Paulo, São Paulo, Brazil
Mean driving pressure between Day 1 and Day 3
Time frame: From Day 1 to Day 3 after randomization
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
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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