NCT01374022

ART - Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial

Randomized Controlled Trial of Maximum Alveolar Recruitment Maneuver Plus Titrated PEEP Versus ARDSNet Strategy for ARDS

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,013 (actual)
• Sponsor: Hospital do Coracao · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Respiratory Distress Syndrome, Adult

Interventions

Type	Name	Description
OTHER	ART Strategy	Maximum alveolar recruitment maneuver in association with PEEP titrated by the static compliance of respiratory system.
OTHER	ARDSNet Strategy	Conventional mechanical ventilation strategy.

Timeline

• Start date: 2011-06-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2011-06-15
• Last updated: 2020-09-11

Locations

1 site across 1 country: Brazil