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临床试验/NCT02412202
NCT02412202已完成不适用

Echocardiographic Detection of Extravascular Lung Water Increase During Weaning From Mechanical Ventilation

University of Thessaly1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Extravascular water increase during weaning from mechanical ventilation measured by echocardiography and thermodilution method

研究概览

简要总结

Switching from positive airway pressure ventilation to spontaneous ventilation during weaning from mechanical ventilation, pulmonary edema may occur and in this case, doppler echocardiographic (U/S) indices of cardiac dysfunction correlates with the concentration of fluid in interstitial space.

Forty consecutive mechanically ventilated critical ill patients who fulfill criteria for weaning from mechanical ventilation, will be included in this study. All patients will be evaluated daily and when the patients fulfill weaning criteria them they will undergo a 2-hour spontaneous breathing trial (SBT) through a T-piece.

Before and after SBT cardiopulmonary function will be assessed by thermodilution and echocardiography. In patients with preserved LV systolic function, an echocardiographic index of diastolic dysfunction (E/Em ratio) before preforming SBT may identify high risk patients for increasing extravascular water in weaning.

In addition, the investigators expect to find positive correlations (p<0.05) between pulmonary extravascular lung water and echocardiographic indices (such as E/Em ratio) during SBT.

详细描述

Pulmonary edema (PE) is an underestimated factor of weaning failure. The interruption of mechanical ventilation

  1. increases left ventricular (LV) afterload, sympathetic tone and may provoke myocardial schema, LV dysfunction and
  2. augments blood in-flow into the thorax and may cause right ventricular dilation and intraventricular septum left shift.

These events may impair LV compliance during weaning, increase intra-capillary pulmonary pressures and cause cardiogenic PE (CPE). The investigators have recently shown that LV diastolic dysfunction may predispose to weaning failure, while echocardiographic markers of CPE may provide further insight in weaning process. Notably, this could be especially true in chronic obstructive pulmonary disease patients where strategies aiming to manage heart failure (i.e. diuretics, nitroglycerin) has been shown to improve weaning outcomes.

In addition, vigorous inspiratory efforts against the endotracheal tube during spontaneous weaning trials may reduce excessively extracapillary pressures in pulmonary interstitial spaces, causing an intra-pulmonary fluid shift known as negative pressure PE (NPPE).

Primary aim: To study whether echocardiographic parameters of left and right ventricular function, and echocardiographic surrogates of cardiogenic PE (markers of elevated LV filling pressures, such as E/Em) are associated to weaning-induced alterations in extravascular lung water index (EVLWI).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • adequate oxygenation (pressure of oxygen in arterial blood (PaO2)>60mmHg with fraction of inspired oxygen (FiO2)<40%, PEEP<5-10cmH2O, PaO2/FIO2>150-300)
  • stable cardiovascular system (Heart rate<140/min, stable blood pressure, without or very minimal vasopressors)
  • absence of sepsis and temperature <38 degree of Celcius
  • no respiratory acidosis
  • adequate hemoglobin (Hb > 8-10g/dL)
  • sufficient (adequate mentation ) arousable Glasgow coma scale >13/15, no continuous sedative infusions
  • Ramsay score<3
  • stable metabolic status (acceptable levels of electrolytes )
  • subjective clinical assessments such as resolution of the acute phase of disease and adequate cough.

排除标准

  • atrial fibrillation or other arrhythmias
  • insufficiency of tricuspidal valve ( +++),
  • continuous venous-venous hemodialysis

结局指标

主要结局

Extravascular water increase during weaning from mechanical ventilation measured by echocardiography and thermodilution method

时间窗: 24 hours

次要结局

未报告次要终点

研究者

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

DEMOSTHENES MAKRIS

AS. PROFESSOR

University of Thessaly

研究点 (1)

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