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ART - Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial

NCT01374022 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1013

Last updated 2020-09-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hospital do Coracao

    lead OTHER

Principal Investigators

  • Alexandre B Cavalcanti, MD, PhD · Hospital do Coracao

  • Carlos RR Carvalho, MD, PhD · Hospital do Coracao, Faculdade de Medicina da Universidade de Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01374022 on ClinicalTrials.gov