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临床试验/NCT03763890
NCT03763890Unknown不适用

Post- End- Expiratory Pressure Affect the Alveolar Heterogeneity in Moderate and Sever ARDS Patients

Southeast University, China1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
plateau pressure

研究概览

简要总结

This study try to use EIT ( Electronic impedance tomography ) to evaluate the alveolar heterogeneity and use trans-pulmonary pressure and stain to evaluate the lung injury . The study use these methods to figure out how PEEP impact the alveolar heterogeneity and VILI.

详细描述

ARDS(Acute respiratory distress syndrome )is common in patients suffering Sepsis, trauma, burning and other sever condition and characterized by diffuse alveolar damage and alveolar heterogeneity.ARDS patient need MV(mechanical ventilation )to maintain oxygenation and need unique MV tragedy to avoid VILI(Ventilator induced Lung injury ).PEEP(post-end-expiratory pressure) is crucial to maintain oxygenation and avoid VILI according to researches. But there are also some other research different voice. This study try to use EIT ( Electronic impedance tomography ) to evaluate the alveolar heterogeneity and use trans-pulmonary pressure and stain to evaluate the lung injury . The study use these methods to figure out how PEEP impact the alveolar heterogeneity and VILI.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

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

入选标准

  • Age≥18 or<80;
  • Moderate or sever ARDS in 2012 <Berlin definition>;
  • Applied mechanical ventilation;
  • Consent signed.

排除标准

  • Asthma or COPD;
  • Cardiogenic edema;
  • Sever neutropenia(<500/mm3);
  • Hemodynamic astatic: DOPA or Dobutamine >15 µg/kg/ min; NE > 15ug /min;
  • GCS coma score ≤12;
  • Thoracic injury or surgery patients contradict EIT ;
  • Refuse to join in trail;
  • Included in other clinical trail。

结局指标

主要结局

plateau pressure

时间窗: September,1,2018-December 30, 2020

The researchers use ventilator to do inspiration pause to measure plateau pressure(cmH2O) in patients with mechanical ventilation and without spontaneous breathing.

Trans-pulmonary pressure

时间窗: September,1,2018-December 30, 2020

The researchers place tube in the esophagus and connect it to transmitter to measure esophageal pressure (mmHg)and calculate trans-pulmonary pressure(mmHg) to evaluate stress

PaO2

时间窗: September,1,2018-December 30, 2020

The researchers use blood gas analysis to measure PaO2( arterial oxygen pressure,mmHg)

PaCO2

时间窗: September,1,2018-December 30, 2020

The researchers use blood gas analysis to measure PaCO2( arterial carbon dioxide pressure,mmHg) .

respiratory rate

时间窗: September,1,2018-December 30, 2020

The researchers record the set respiratory rate(bpm) in patients with mechanical ventilation.

peak pressure

时间窗: September,1,2018-December 30, 2020

The researchers use ventilator to measure peak pressure(cmH2O) in patients with mechanical ventilation and without spontaneous breathing..

flow

时间窗: September,1,2018-December 30, 2020

The researchers record the set Flow (L/min) in patients with mechanical ventilation.

alveolar hyper-distention; alveolar collapse;alveolar opening and closing;

时间窗: September,1,2018-December 30, 2020

The study use Pulmo Vista 500 device (Drager co.),is intended to perform thoracic bioimpedance measurements by applying the technique of electrical impedance tomography (EIT)to evaluate alveolar hyper-distention(%of the lung volume); alveolar collapse(% of the lung volume);alveolar opening and closing(% of the lung volume).

EELV

时间窗: September,1,2018-December 30, 2020

The research use nitrogen wash out to measure EELV(end-expiratory lung volume, ml) to calculate dynamic strain and evaluate the strain

tidal volume

时间窗: September,1,2018-December 30, 2020

The researchers use ventilator to measure tidal volume(ml) in patients with mechanical ventilation and without spontaneous breathing..

FiO2

时间窗: September,1,2018-December 30, 2020

The researchers record the set FiO2 ( fraction of inspiratory oxygen, %) in patients with mechanical ventilation.

次要结局

  • DBP(September,1,2018-December 30, 2020)
  • CVP(September,1,2018-December 30, 2020)
  • SBP(September,1,2018-December 30, 2020)
  • vasopressor(September,1,2018-December 30, 2020)

研究者

发起方
Southeast University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ling Liu

Director

Southeast University, China

研究点 (1)

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