ART - Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial

Hospital do Coracao

Status: Completed

Conditions: Respiratory Distress Syndrome, Adult

Treatments: Other: ARDSNet Strategy; Other: ART Strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT01374022

CAAE - 0025.1.160.000-11

Details and patient eligibility

About

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.

Enrollment: 1,013 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• intubated, mechanically ventilated patients with diagnosis of moderate to severe ARDS less than 72 hours

Exclusion criteria

• age less than 18 years
• use of vasopressor drugs in increasing doses over the last 2 hours or mean arterial blood pressure less than 65mmHg
• presence of any contraindication to hypercapnia as intracranial hypertension or acute coronary syndrome
• pneumothorax, pneumomediastinum, subcutaneous emphysema or pneumatocele
• patient with no therapeutic perspective, candidates for palliative care exclusively
• patient previously randomized in the ART

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,013 participants in 2 patient groups

ART Strategy

Experimental group

Description:

maximum alveolar recruitment plus PEEP titration

Treatment:

Other: ART Strategy

ARDSNet Strategy

Active Comparator group

Description:

standard strategy (ARDSNet)

Treatment:

Other: ARDSNet Strategy