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临床试验/NCT01552070
NCT01552070已完成2 期

Impact of Alveolar Recruitment Maneuver on Extravascular Lung Water of Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome.

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年9月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Extravascular lung water change with/without recruitment maneuver.

研究概览

简要总结

The purpose of this study is to investigate the change of extravascular lung water (EVLW), cytokine and oxygenation parameters in patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) after alveolar recruitment maneuver.

详细描述

This investigation is a prospective randomized control study. Informed consents will be obtained from all patients or their surrogates prior to the procedure of alveolar recruitment maneuver and PiCCO monitoring system.

Patients and methods:

From September 2010 to September 2012, consecutive patients with ALI/ARDS undergo alveolar recruitment maneuver will be enrolled at Chang Gung Memorial Hospital, a university-affiliated hospital in Taiwan. EVLW will be measured by PiCCO monitoring system, alveolar recruitment maneuver will be setting by protocol under supervision of chest physicians and respiratory therapists. Serum cytokine such as endothelin-1, TNF-, IL-6, Tie-1, Tie-2, angiopoietin-1, angiopoietin-2,VEGF and thrombomodulin will be measured.

研究设计

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

入排标准

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

入选标准

  • acute hypoxemic respiratory failure requiring intubation; and hypoxemia, defined as a partial pressure of arterial oxygen (PaO2) less than 100 mmHg under a high fraction of inspired oxygen (FiO2)
  • PaO2/FiO2 ratio < 200.

排除标准

  • encephalopathy or coma,
  • a need for cardiac resuscitation,
  • hyperkalemia of more than 5.5 mEq/L (contraindication to the succinylcholine use),
  • acute brain injury,
  • pregnancy,
  • age less 20 years old or recent thoracic surgery.

结局指标

主要结局

Extravascular lung water change with/without recruitment maneuver.

时间窗: 7 days

The Extrvascular lung water (EVLW) measurement will be based on transpulmonary thermodilution method. This method was recently introduced as part of the PiCCO plus system (Pulsion Medical System, Munich, Germany). EVLW were recorded and compared between patients with and without recruitment manevuer.

次要结局

  • ICU survival(28days)
  • cytokines change with/without recruitment maneuver.(28 days)
  • ventilator use duration(28days)
  • weaning rate(28days)
  • ICU stay(28days)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chung Fu-Tsai

Chief of The Fifth Medical Intensive Care Unit , Assistant Professor

Chang Gung Memorial Hospital

研究点 (2)

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