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临床试验/NCT01113073
NCT01113073Unknown不适用

The Distribution of Pressure in the Thorax During Mechanical Ventilation and Its Effects on the Circulation

Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
fluid responsiveness

研究概览

简要总结

Fluid administration is a daily intervention on the intensive care unit to improve cardiac output (CO) and stabilize circulation in critically ill patients. Simultaneously, the volume status of the patient is very difficult to assess. Too little volume leads to inadequate organ perfusion followed by ischemia and organ failure. Too much volume may worsen heart failure and cause pulmonary and peripheral edema and contribute to further tissue injury and organ dysfunction. Although dynamic indices have been shown to be more accurate predictors of fluid responsiveness, this relevant and complex task is usually guided by static clinical variables and the specialist's interpretation due to the fact that the interpretation of dynamic parameters is not fully developed and that they are not universally available. This lack of understanding is partially because of the complex interaction with mechanical ventilation. The investigators hypothesize that knowing the distribution of ventilatory pressures will make it possible to index dynamic parameters to tidal volume and improve their predictive value concerning the volume status of the patient. In addition, it would be of interest to be able to predict fluid responsiveness in a non-invasive way, especially in critically ill patients. Up to now, continuous non-invasive cardiac output monitoring using Nexfin in critically ill patients has not been validated and also not tested for its ability to predict fluid responsiveness. The present research proposal evaluates the possibility and accuracy of the model flow analysis obtained by non-invasive finger arterial pressure measurements to determine fluid responsiveness using passive leg raising. It will also be compared to a more invasive method (that is currently used in the clinic) to assess its ability to measure absolute CO levels accurately. It may make it possible to assess fluid responsiveness in a non-invasive and patient friendly way.

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

性别
All
接受健康志愿者

入选标准

  • Elective open heart surgery.

排除标准

  • Significant cardiac arrhythmias, including atrial fibrillation.
  • Hemodynamical instability, as defined by a variation in heart rate, blood pressure and cardiac output of more than 10% during the 15-min period before starting the protocol.
  • Recent myocardial infarction (< 3 mnd, troponine > 50 ug/l).

结局指标

主要结局

fluid responsiveness

时间窗: 30 minutes around fluid challenge

pulse pressure variation (PPV), systolic pressure variation (SPV), stroke volume variation (SVV), pre-ejection period variation (dPEP)

次要结局

  • Pressure distribution in thorax due to mechanical ventilation(30 minutes of varying tidal volumes)
  • Dynamic indices in pressure support ventilation(30 minutes of pressure support)
  • non invasive prediction of fluid responsiveness(30 minutes around fluid challenge)
  • pressure distribution and dynamic indices during spontaneous breathing(5 minutes of spontaneous breathing)

研究者

申办方类型
Other

研究点 (1)

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