Statistical analysis plan for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART). A randomized controlled trial.

ABSTRACT:

Background

The Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) is an international multicenter randomized pragmatic controlled trial with allocation concealment involving 120 intensive care units in Brazil, Argentina, Colombia, Italy, Poland, Portugal, Malaysia, Spain, and Uruguay. The primary objective of ART is to determine whether maximum stepwise alveolar recruitment associated with PEEP titration, adjusted according to the static compliance of the respiratory system (ART strategy), is able to increase 28-day survival in patients with acute respiratory distress syndrome compared to conventional treatment (ARDSNet strategy).

Objective

To describe the data management process and statistical analysis plan.

Methods

The statistical analysis pla

SUBMITTER: Damiani LP 

PROVIDER: S-EPMC5496748 | biostudies-literature | 2017 Apr-Jun

REPOSITORIES: biostudies-literature