跳至主要内容
临床试验/NCT00431158
NCT00431158已完成不适用

ARDSnet Protocol vs. the Open Lung Approach for the Ventilatory Management of Severe, Established ARDS: A Global Randomized Controlled Trial

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2007年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
224
试验地点
1
主要终点
60 day mortality

研究概览

简要总结

Many patients with Acute Respiratory Distress Syndrome or ARDS need breathing support that is provided by a machine called a ventilator or respirator. The purpose of this study is to find out if a new method of setting the ventilator for patients with severe ARDS is better than the standard, commonly used way of setting the ventilator.

详细描述

The ARDSnet protocol is the current, standard of care for ARDS. Mechanical ventilation is managed using low tidal volumes, relatively high respiratory rates, with oxygenation managed according to PEEP and FIO2 relationships as defined in a table. This study compares the ARDSnet protocol with an open lung approach to mechanical ventilation. The open lung approach uses a technique to recruit collapsed lung areas and then uses the lowest PEEP level that prevents recollapse of recruited lung units. The best PEEP level is determined by a decremental PEEP trial involving a series of pressure measurements taken after the recruitment maneuver. Both the ARDSnet protocol and the open lung approach require low tidal volumes and plateau pressures.

Evidence suggests that using a mechanical ventilation strategy of recruitment maneuvers (to open the collapsed lung) followed by high PEEP (to prevent collapse of the opened lung) with control of transpulmonary pressure through lower plateau pressures would maximize homogeneity within the lung and as such, minimize shearing forces in the lung parenchyma, thus improving ventilation and outcome in mechanically ventilated ARDS patients.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Intubated and mechanically ventilated
  • •Diagnosis of ARDS using American-European consensus criteria
  • •Enrollment in study < 48 hours since diagnosis of ARDS
  • •For 12-36 hrs. (ideally 12-24 hrs) after diagnosis of ARDS, patient must be ventilated as follows: Volume A/C, Tidal volume of 4-8 ml/kg PBW, Plateau pressure ≤ 30 cmH2O, PEEP/FIO2 adjustments using ARDSnet table, Ventilator rate to keep PaCO2 = 35-60 mmHg
  • •During the 12-36 hour(ideally 12-24 hr) period, PaO2/FIO2 must remain < 200 mm Hg for an ABG obtained 30 minutes after placement on the following specific ventilator settings: Volume A/C, Tidal volume = 6 ml/kg PBW, Plateau pressure ≤ 30 cmH2O, Inspiratory time ≤ 1 second, PEEP ≥ 10 cmH2O, FIO2 ≥ 0.5, Ventilator rate to keep PaCO2 = 35-60 mmHg
  • •No lung recruitment maneuvers or adjunct therapy.
  • •Total time on mechanical ventilation < 96 hrs. at time of randomization.

排除标准

  • •Age < 18 years or > 80 years
  • •Weight < 35 kg PBW
  • •Body mass index > 60
  • •Intubated 2° to acute exacerbation of a chronic pulmonary disease
  • •Acute brain injury (ICP > 18 mmHg)
  • •Immunosuppression 2° to chemo- or radiation therapy
  • •Severe cardiac disease(one of the following): New York Heart Association Class 3 or 4, acute coronary syndrome or persistent ventricular tachyarrhythmias
  • •Positive laboratory pregnancy test
  • •Sickle cell disease
  • •Neuromuscular disease
  • •High risk of mortality within 3 months from cause other than ARDS, e.g. cancer
  • •More than 2 organ failures (not including pulmonary system)
  • •Documented lung barotrauma, i.e. chest tube placement other than for fluid drainage
  • •Persistent hemodynamic instability or intractable shock
  • •Penetrating chest trauma
  • •Enrollment in another interventional study

研究组 & 干预措施

2

Active Comparator

OLA Protocol

干预措施: Different Mechanical Ventilation Protocols (Other)

1

Active Comparator

ARDSnet Protocol

干预措施: Different Mechanical Ventilation Protocols (Other)

结局指标

主要结局

60 day mortality

时间窗: 60 days

次要结局

  • 365 day mortality(365 days)
  • Lung function 6 months after discharge(6 months)
  • Lung function 12 months after discharge(12 months)
  • Need for rescue therapy(Duration of hospital stay)
  • 28 day mortality(28 days)
  • Hospital mortality(Duration of hospital stay)
  • Ventilator free days(Hospital stay)
  • Incidence of barotrauma(Duration of hospital stay)
  • Ventilation associated pneumonia rate(Duration of hospital stay)
  • 180 day mortality(180 days)
  • Duration of hospitalization(Duration of hospital stay)
  • ICU mortality(Duration of ICU stay)
  • Length of ICU stay(Duration of ICU stay)
  • Development of extra-pulmonary organ failures(Duration of hospital stay)
  • Systemic inflammatory mediator levels(Duration of hospital stay)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert M. Kacmarek

Professor of Anesthesia, Director of Respiratory Care Services

Massachusetts General Hospital

研究点 (1)

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