ART - Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1013 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Respiratory Distress Syndrome, Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ART Strategy

maximum alveolar recruitment plus PEEP titration

Group Type EXPERIMENTAL

ART Strategy

Intervention Type OTHER

Maximum alveolar recruitment maneuver in association with PEEP titrated by the static compliance of respiratory system.

ARDSNet Strategy

standard strategy (ARDSNet)

Group Type ACTIVE_COMPARATOR

ARDSNet Strategy

Intervention Type OTHER

Conventional mechanical ventilation strategy.

Interventions

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ART Strategy

Maximum alveolar recruitment maneuver in association with PEEP titrated by the static compliance of respiratory system.

Intervention Type OTHER

ARDSNet Strategy

Conventional mechanical ventilation strategy.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No