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临床试验/NCT05198986
NCT05198986Unknown不适用

Effects of Pronation on Respiratory System Mechanical Properties and Ventilation in Patients With Acute Respiratory Distress Syndrome During Vv-ecmo

University Magna Graecia1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年2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
15
试验地点
1
主要终点
Driving Pressure

研究概览

简要总结

The Acute Respiratory Distress Syndrome (ARDS) is defined by a recent (within 1 week) respiratory failure, not fully explained by cardiac failure or fluid overload. ARDS is also characterized by bilateral opacities at the chest imaging, with an alteration of the oxygenation while positive end-expiratory pressure equal or greater than 5 cmH2O is applied. Severe ARDS is characterized by a high mortality. In the most severe ARDS patients, venovenous extracorporeal membrane oxygenation (vv-ECMO) is increasingly accepted as a mean to support vital function, although not free from complications.

In patients with severe ARDS, prone position has been used for many years to improve oxygenation. In these patients, early application of prolonged (16 hours) prone-positioning sessions significantly decreased 28-day and 90-day mortality. More recently, prone position and ECMO have been coupled as concurrent treatment. Indeed, the addition of prone positioning therapy concurrently with ECMO can aid in optimizing alveolar recruitment, and reducing ventilator-induced lung injury. Nowadays, few data exist on respiratory mechanics modifications before and after the application of prone position in patients with severe ARDS receiving vv-ECMO. The investigators have therefore designed this observational study to assess the modifications of mechanical properties of the respiratory system, ventilation and aeration distribution, and hemodynamics occurring during ECMO before and after prone position in patients with severe ARDS.

研究设计

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

入排标准

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

入选标准

  • all adult patients with a diagnosis of severe Acute Respiratory Distress Syndrome receiving veno-venous ECMO

排除标准

  • mechanical ventilation for 7 days or longer
  • pregnancy
  • body mass index (BMI) > 45 kg/m2
  • chronic respiratory failure with long-term oxygen therapy or domiciliary non-invasive ventilation
  • cardiac failure resulting in veno-arterial ECMO
  • history of heparin- induced thrombocytopenia
  • cancer with a life expectancy of less than 5 years
  • moribund condition or a Simplified Acute Physiology Score (SAPS-II) value of more than 90;
  • current non drug- induced coma after cardiac arrest or presence of an irreversible neurologic injury
  • decision to withhold or withdraw life--sustaining therapies
  • presence of pneumothorax and/or pulmonary emphysema
  • recent (1 week) thoracic surgery
  • presence of chest burns
  • inclusion in other research protocols
  • refusal of consent.

结局指标

主要结局

Driving Pressure

时间窗: 30 minutes after the prone positioning

Difference between the airway plateau pressure and the total positive end-expiratory pressure after an inspiratory and expiratory hold maneuvers, respectively

次要结局

  • Respiratory system compliance(30 minutes after the prone positioning)
  • Cardiac output(30 minutes after the prone positioning)
  • Pulmonary arterial pressure(30 minutes after the prone positioning)
  • End-Expiratory Lung Impedance(30 minutes after the prone positioning)

研究者

发起方
University Magna Graecia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Federico Longhini

Prof

University Magna Graecia

研究点 (1)

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