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临床试验/NCT03498807
NCT03498807已完成不适用

A Comparison of Optimal Positive End Expiratory Pressure Determination Guided by Electrical Impedance Tomography and Conventional Protective Ventilation Tool in Acute Respiratory Distress Syndrome Patients

Hui-Ju Hsu2 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2017年4月13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
87
试验地点
2
主要终点
Compare the survival rate between two groups

研究概览

简要总结

The study of positive end-expiratory pressure(PEEP) in the setting mode has not yet been conclusive. there are several ways to choose the best positive end-expiratory pressure(PEEP) mode for ARDS patients. In this study ,the investigators selected two best positive end-expiratory pressure(PEEP) assessment methods to compare:

First is using the conventional postive ventilator to choose positive end-expiratory pressure(PEEP) and the new non-invasive electrical impedance tomography(EIT) guided method and evaluation the treatment outcome in moderate and severe acute respiratory distress syndrome patients by using pressure-volume curve guided and electrical impedance tomography guided positive end-expiratory pressure setting. In this project, we utilize a newly available non-invasive method- electric impedance tomography (EIT) and Protective Ventilation to determine the optimal PEEP on ARDS patients required invasive mechanical ventilator support at a medical center medical ICU (MICU) and cardiovascular ICU (CVICU)- the Far Eastern memorial hospital, Taiwan.

详细描述

Acute respiratory distress syndrome (ARDS),over the years in the treatment policy has been confirmed that: with low tidal volume to achieve lung protection strategy and high positive end-expiratory pressure (PEEP), both can effectively reduce the mortality rate. And increase PEEP,the alveolar pressure is greater than the atmospheric pressure when exhaled,So that can be effective expansion of the lungs to avoid spitting at the end of the alveolar collapse.

The study of PEEP in the setting mode has not yet been conclusive. Currently in the clinical situation,there are several ways to choose the best PEEP mode for ARDS patients. In this study the investigators selected two best PEEP assessment methods to compare:

First is using the conventional postive ventilator to choose optimal and the new non-invasive electrical impedance tomography guided method and evaluation the treatment outcome in moderate and severe acute respiratory distress syndrome patients by using pressure-volume curve guided and electrical impedance tomography guided positive end-expiratory pressure setting. In this project, the investigators utilize a newly available non-invasive method- electric impedance tomography (EIT) and Protective Ventilation to determine the optimal PEEP on ARDS patients required invasive mechanical ventilator support in ICU at the Far Eastern memorial hospital, Taiwan.

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)

盲法说明

During this period, all patients were total sedation using continuous infusion, to prevent any spontaneous breathing .All patients were ventilated using a ventilator

入排标准

年龄范围
20 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Moderate to severe ARDS patient on mechanical ventilation from ER or word transfer ICU. (P/F≦ 200 with PEEP ≥ 5cmH20) (PEEP greater than or equal to 5 cm H2O and Berlin criteria for ARDS)

排除标准

  • On pacemaker
  • Thoracic or spinal cord trauma
  • Pneumothorax
  • Hemodynamic instability

结局指标

主要结局

Compare the survival rate between two groups

时间窗: Compare the survival rate between two groups during 91 days in hospitalization

Calculate the survival rate

次要结局

  • Oxygention improve rate in the hospital(Compare the PaO2/FiO2 ratio after fixed Optimal PEEP 48hrs later)

研究者

发起方
Hui-Ju Hsu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hui-Ju Hsu

respiratory therapist

Far Eastern Memorial Hospital

研究点 (2)

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