跳至主要内容
临床试验/NCT01374022
NCT01374022已完成不适用

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

Hospital do Coracao2 个研究点 分布在 1 个国家目标入组 1,013 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,013
试验地点
2
主要终点
Survival in 28 days

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Survival in 28 days

时间窗: 28 days

Survival within 28 days from randomization

次要结局

  • In-hospital survival(Maximum 6-months)
  • Days free of mechanical ventilation(28 days)
  • ICU survival(Maximum 6-months)
  • Pneumothorax requiring drainage(7 days)
  • Lenght of ICU stay(Maximum 6-months)
  • Barotrauma(7 days)
  • 6-month survival(6 months)
  • Lenght of hospital stay(Maximum 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

ART - Alveolar Recruitment for Acute Respiratory... | 临床试验