Clinical trial NCT02376647: ART-3 Pilot - Driving Pressure Limited Ventilation for Patients Without ARDS (ART3pilot)
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mechanical Ventilation
Acute Respiratory Distress Syndrome
Keywords: Patients
ARDS diagnosis
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
Collaborators: name: Brazilian Research in Intensive Care Network (BRICNet)
First posted: 2015-03-03
Enrollment: 0
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 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.

Eligibility criteria: Inclusion Criteria:

* Patients on invasive mechanical ventilation for less than 72 hours and without diagnosis of ARDS, and no perspective of extubation in 24 hours.

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: From Day 1 to Day 3 after randomization
Secondary outcomes:
measure: Rate of investigators adering to study procedures
timeFrame: Days 1 to 7
measure: Rate of driving pressure equal or lower than 13 cmH2O
timeFrame: Days 1 to 3 after randomization
measure: Mean of positive end expiratory pressure (PEEP) from day 1 to 7
timeFrame: Days 1 to 7
measure: Mean tidal volume from day 1 to 7
timeFrame: Days 1 to 7
measure: Mean static compliance of the respiratory system from day 1 to 7
timeFrame: Days 1 to 7
measure: Mean plateau pressure from day 1 to 7
timeFrame: Days 1 to 7
measure: Mean driving pressure from day 1 to 7
timeFrame: Days 1 to 7
measure: Mean respiratory rate from day 1 to 7
timeFrame: Days 1 to 7
measure: Number of patients with barotrauma
timeFrame: Days 1 to 7
measure: Mean of severe acidosis (pH <7.1)
timeFrame: Days 1 to 7
measure: Number of patients with other adverse events
timeFrame: Days 1 to 7
measure: Lenght of stay in intensive care unit
timeFrame: Patients will be followed during the period of ICU stay, an expected average of 28 days
measure: Lenght of stay in hospital
timeFrame: Patients will be followed during the period of hospital stay, an expected average of 28 days
measure: Number of mechanical ventilation free days from day 0 to day 28
timeFrame: From day 0 to day 28
measure: ICU mortality
timeFrame: Patients will be followed during the period of hospital stay, an expected average of 28 days
measure: In-hospital mortality
timeFrame: Patients will be followed during the period of hospital stay, an expected average of 28 days
measure: 28-day survival
timeFrame: From day 0 to day 28
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Alexandre Biasi Cavalcanti
state: SP
Study officials:
affiliation: Hospital do Coração(Heart Hospital)
name: Alexandre B Cavalcanti, MD, PhD
role: STUDY_CHAIR
References: