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临床试验/NCT01114009
NCT01114009已完成不适用

Effects of Recruitment Maneuvers in Early ALI and ARDS Patients

LUN WEI LIU1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2009年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
28-day hospital mortality

研究概览

简要总结

The purpose of this study is to evaluate the effect of lung recruitment maneuver in patients with early ALI/ARDS

详细描述

The acute respiratory distress syndrome (ARDS) was first described in the medical literature in 1967. Patients with ARDS mostly require mechanical ventilatory support due to hypoxic respiratory failure. Mechanical ventilation can induce lung injury (ventilator-induced lung injury, VILI) by causing overdistention and repetitive opening and closing of unstable lung units. Data from a number of randomized controlled trials indicate that a lung protective ventilatory strategy with small tidal volume and low plateau pressure reduces mortality in acute lung injury (ALI) and acute respiratory distress syndrome. Lung recruitment maneuvers are being used in the management of ALI and ARDS, but recruitment maneuvers are still controversial. Lung recruitment maneuver is aimed to open the collapsed lung and keep the lung open. The maneuver briefly increases the alveolar pressure to open recruitable lung, sustained with adequate positive end-expiratory pressure(PEEP) after lung recruitment, to avoid derecruitment. We want to enroll 120 patients with early ALI/ARDS in this randomized controlled study. The study group use recruitment maneuver and lung protective ventilatory strategy, and the control group use lung protective ventilatory strategy only. Concerning about both safety and efficacy, we design a modified recruitment maneuver protocol which has never been published in previous medical literature. The primary outcome is ventilator-free days and ICU-free days, and secondary outcomes include ventilator weaning rate, and 28-day mortality and cost effectiveness analysis. Since no randomized controlled trials clearly establish benefit from recruitment maneuvers, we hope this study would be able to provide some evidence on whether lung recruitment should be used in the routine management of ALI/ARDS.

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
Single (Participant)

入排标准

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

入选标准

  • met criteria of ALI/ARDS
  • PaO2/FiO2 less than or equal 250 mmHg after standard ventilator setting (FiO2 more than or equal 0.5 and PEEP more than or equal 10 cmH2O)at least 30 mins

排除标准

  • age less than 18 years
  • duration of mechanical ventilator more than 72 hours
  • Pneumothorax or subcutaneous emphysema or bullous lung disease
  • severe chronic respiratory disease
  • intracranial hypertension or received craniotomy surgery
  • longterm dependent ventilator
  • Neuromuscular disease
  • premorbid conditions with an expected 6 month mortality risk exceeding 50%

结局指标

主要结局

28-day hospital mortality

时间窗: Two year

次要结局

  • Ventilator-free days(Two year)
  • Ventilator weaning rate(Two years)
  • Cost-effectiveness analysis(Two years)
  • ICU-free days(Two years)

研究者

发起方
LUN WEI LIU
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

LUN WEI LIU

Chi Mei Medical Hospital

Chi Mei Medical Hospital

研究点 (1)

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