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临床试验/NCT04141293
NCT04141293撤回不适用

Hemodynamic Effects of Changes in Transpulmonary Pressure During Recruitment Maneuver in Patients Under Pressure Support Mechanical Ventilation

Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged2 个研究点 分布在 1 个国家开始时间: 2017年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Comparison of transpulmonary pressure and hemodynamic changes during alveolar recruitment

研究概览

简要总结

According to the anatomical proximity of the heart temporarily elevated intrathoracic pressures may have direct and indirect effects on the cardiovascular system. Undesirable hemodynamic effects of a recruitment maneuver primarily arise from the transiently increased airway pressure, manifesting in decreased right heart filling, increased pulmonary vascular resistance, a drop in left ventricular systolic transmural pressure, right and left heart ventricular interactions and subsequent changes in cardiac index. These effects can be more pronounced in patients suffering from ARDS, a condition commonly accompanied by hemodynamic instability. The complex pathophysiological changes account for why routine intensive care monitoring, such as invasive arterial blood pressure or central venous pressure monitoring is insufficient to follow hemodynamic changes under recruitment maneuver.

Previous studies by the same research team confirmed that the alveolar recruitment maneuver improves oxygenation in patients with moderate-to-severe hypoxemic respiratory failure under pressure supported ventilation. Following recruitment maneuver, arterial oxygenation increased in 74 % of all patients. However, there is lack of information regarding the actual degree of changes in transpulmonary pressure and the consequent hemodynamic alterations.

The primary aim of the study is to evaluate precisely the transpulmonary pressure changes during recruitment in patients with severe hypoxemic respiratory failure ventilated in pressure support mode following insertion of a balloon-catheter into the esophagus. In the meantime, hemodynamic changes are monitored by PiCCO and transthoracic echocardiography, and lung field aeration by electric impedance tomography.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

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

  • orotracheal intubation
  • pressure supported ventilation
  • moderate-to-severe hypoxemic respiratory failure according to ARDS Berlin Criteria Moderate: 100 Hgmm ≤ PaO2/FiO2 ≤ 200 Hgmm, PEEP ≥ 5 cmH2O Severe: PaO2/FiO2 ≤ 100 Hgmm, PEEP ≥ 5 cmH2O

排除标准

  • age < 18 years
  • pregnancy
  • previous pulmonary resection, pulmonectomy
  • clinically verified, end-stage COPD
  • severe hemodynamic instability (i.e. refractory shock to vasopressors)
  • severe emphysema and/or spontaneous pneumothorax in past medical history
  • contraindications of a balloon-catheter (e.g. esophageal abscess, esophageal perforation, esophageal diverticulosis, esophagus tumor, esophagus varix, recent esophagus or gastric surgery, severe coagulopathy)

研究组 & 干预措施

Eligible patients

Experimental

干预措施: alveolar recruitment (Procedure)

结局指标

主要结局

Comparison of transpulmonary pressure and hemodynamic changes during alveolar recruitment

时间窗: Approximately 35 minutes

Changes in transpulmonary pressure during alveolar recruitment will be compared to the subsequent hemodynamic alterations

次要结局

  • Changes in pulmonary air content(Approximately 30 miniutes)
  • Changes in arterial oxygen content(Approximately 5 minutes)
  • Changes in hemodynamic parameters (SV)(35 minutes)
  • Changes in hemodynamic parameters (MAP)(35 minutes)
  • Changes in hemodynamic parameters (HR)(35 minutes)
  • Changes in hemodynamic parameters (CI)(35 minutes)
  • Changes in left and right ventricular volume (systolic ventricular interdependence)(Approximately 3 minutes)

研究者

发起方
Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

András Lovas

Head of Department

Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged

研究点 (2)

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