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临床试验/NCT02365038
NCT02365038已完成1 期

ART-2 Pilot: A Controlled, Randomized Trial to Assess the Feasiblity of a Driving Pressure Limited Ventilation vs. Standard Strategy (ARDSNet) in Patients With ARDS

Hospital do Coracao0 个研究点目标入组 20 人开始时间: 2015年6月12日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
20
主要终点
Mean driving pressure between day 1 and day 3

研究概览

简要总结

This is a multicenter randomized controlled pilot trial to investigate the feasibility of a driving pressure limited mechanical ventilation strategy compared to the ARDS Clinical Network strategy (conventional strategy) in patients with acute respiratory distress syndrome (ARDS).

详细描述

Mechanical ventilation has the potential to produce or worsen alveolar injury. Driving pressure is the difference between plateau pressure and PEEP. Evidence from observational studies suggests that elevated driving pressure is the main independent determinant of ventilator-induced lung injury, however clinical trials are needed to establish whether targeting low driving pressures can improve clinical outcomes in patients with acute respiratory distress syndrome (ARDS). Thus, ART2pilot is a multicenter randomized controlled trial to assess the feasibility of a driving pressure limited mechanical ventilation strategy compared to the ARDS Clinical Network strategy (conventional strategy) in patients with ARDS. Patients considered to this trial are those in mechanical ventilation with diagnosis of ARDS of less than 72 hours duration. We will exclude patients with less than 18 years old; contraindication to hypercapnia such as intracranial hypertension or recent acute coronary syndrome; patients in which a high probability of death within 24 hours is anticipated and patients under exclusive palliative care. Eligible patients will be randomized to the driving pressure limited ventilation strategy or ARDSNet strategy. The primary outcome is driving pressure between days 1 and 3.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Mean driving pressure between day 1 and day 3

时间窗: Day 1 to Day 3 after randomization

Driving pressure is the difference between plateau pressure and PEEP. It will be measured every morning in patients without spontaneous efforts. As every patients will have up to three measurements, we will consider the mean driving pressure for each patient.

次要结局

  • Adherence to study procedures: daily adjustement of driving pressure in experimental group and tidal volume in the control group(Days 1 to 7)
  • Mean plateau pressure from day 1 to day 7(Days 1 to 7)
  • Mean driving pressure from day 1 to day 7(Days 1 to 7)
  • In-hospital mortality(Hospital stay)
  • Mean respiratory rate from day 1 to day 7(Days 1 to 7)
  • Barotrauma(Days 1 to 7)
  • Mean PEEP from day 1 to 7(Days 1 to 7)
  • Mean tidal volume from day 1 to day 7(Days 1 to 7)
  • Length of stay in hospital(In-hospital stay)
  • Mechanical ventilation free days from day 0 to day 28(From day 0 to day 28)
  • 28-day survival(From day 0 to day 28)
  • Other adverse events(Days 1 to 7)
  • Rate of driving pressure equal or lower than 13cmH2O(Days 1 to 3 after randomization)
  • Mean static compliance of the respiratory system from day 1 to day 7(Days 1 to 7)
  • Severe acidosis (pH <7.1)(Days 1 to 7)
  • Length of stay in intensive care unit(ICU stay)
  • ICU mortality(ICU stay)

研究者

申办方类型
Other
责任方
Sponsor

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