Clinical trial NCT02365038: ART-2 Pilot - Driving Pressure Limited Ventilation for Patients With ARDS
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

* Patients on invasive mechanical ventilation with diagnosis of ARDS of less than 72 hours duration.

Exclusion criteria:

* 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.

Primary outcomes:
measure: Mean driving pressure between day 1 and day 3
timeFrame: Day 1 to Day 3 after randomization
Secondary outcomes:
measure: Adherence to study procedures: daily adjustement of driving pressure in experimental group and tidal volume in the control group
timeFrame: Days 1 to 7
measure: Rate of driving pressure equal or lower than 13cmH2O
timeFrame: Days 1 to 3 after randomization
measure: Mean PEEP from day 1 to 7
timeFrame: Days 1 to 7
measure: Mean tidal volume from day 1 to day 7
timeFrame: Days 1 to 7
measure: Mean static compliance of the respiratory system from day 1 to day 7
timeFrame: Days 1 to 7
measure: Mean plateau pressure from day 1 to day 7
timeFrame: Days 1 to 7
measure: Mean driving pressure from day 1 to day 7
timeFrame: Days 1 to 7
measure: Mean respiratory rate from day 1 to day 7
timeFrame: Days 1 to 7
measure: Barotrauma
timeFrame: Days 1 to 7
measure: Severe acidosis (pH <7.1)
timeFrame: Days 1 to 7
measure: Other adverse events
timeFrame: Days 1 to 7
measure: Length of stay in intensive care unit
timeFrame: ICU stay
measure: Length of stay in hospital
timeFrame: In-hospital stay
measure: Mechanical ventilation free days from day 0 to day 28
timeFrame: From day 0 to day 28
measure: ICU mortality
timeFrame: ICU stay
measure: In-hospital mortality
timeFrame: Hospital stay
measure: 28-day survival
timeFrame: From day 0 to day 28
Other outcomes:
Locations:
Study officials:
affiliation: Hospital do Coracao (Heart Hospital)
name: Alexandre B Cavalcanti, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.