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临床试验/NCT05132933
NCT05132933已完成不适用

Gas Exchange Derangement Physiopathology and Response to Different Levels of Positive End-expiratory Pressure in Critically Ill Patients With COVID-19

Policlinico Hospital2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14
试验地点
2
主要终点
Shunt at three different levels of positive end expiratory pressure (PEEP)

研究概览

简要总结

The study was designed to understand the pathophysiology of gas exchange derangement in critically ill patients with COVID-19. Specifically we will evaluate the effect of 3 different levels of positive end-expiratory pressure (PEEP) and two different levels of inspiratory oxygen fraction (FiO2) on gas exchange by analyzing shunt and dead space. Furthermore, complete respiratory mechanics and distribution of ventilation and perfusion by electrical impedance tomography will be assessed at each level of PEEP.

研究设计

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

  • Patients admitted in intensive care unit for COVID-19 related Acute Respiratory Distress Syndrome (ARDS) requiring invasive mechanical ventilation

排除标准

  • Pregnancy
  • Hemodynamic instability (80-90 mmHg increase or 30-40 mmHg decrease systolic arterial pressure compared to baseline value or need of vasopressors to maintain systolic blood pressure higher than 85 mmHg or electrocardiogram evidence of ischemia/arrhythmias)
  • Presence of pneumothorax and/or pneumomediastinum
  • Contraindications to Electrical Impedance Tomography (pacemaker, implantable cardioverter defibrillator, thoracic drainages)

结局指标

主要结局

Shunt at three different levels of positive end expiratory pressure (PEEP)

时间窗: 30 minutes after change of positive end expiratory pressure (PEEP) level

Shunt measured by arterial and mixed venous blood samples at each level of PEEP

次要结局

  • Ventilation/perfusion at three different levels of positive end expiratory pressure (PEEP) assessed by electrical impedance tomography (EIT)(30 minutes after change of positive end expiratory pressure (PEEP) level)
  • Respiratory mechanics at three different levels of positive end expiratory pressure (PEEP)(30 minutes after change of positive end expiratory pressure (PEEP) level)
  • Dead space at three different levels of positive end expiratory pressure (PEEP)(30 minutes after change of positive end expiratory pressure (PEEP) level)
  • Shunt and dead space at two different levels of inspiratory oxygen fraction for each level of positive end expiratory pressure (PEEP)(30 minutes after change of positive end expiratory pressure (PEEP) level)

研究者

发起方
Policlinico Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giacomo Grasselli

MD, Professor

Policlinico Hospital

研究点 (2)

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