跳至主要内容
临床试验/NCT04632602
NCT04632602已完成不适用

Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure: a Randomized Cross Over Electrical Impedance Tomography Study

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年4月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Global Inhomogeneity Index variations (expressed in percentage) between baseline, supine and prone position periods.

研究概览

简要总结

Evaluation of awake prone position on ventilation inhomogeneity in COVID-19 associated respiratory failure.

详细描述

Awake prone position has been proposed as an additional treatment to alleviate hypoxemia during COVID-19 acute respiratory failure and potentially to avoid in some case tracheal intubation and invasive ventilation. Potential mechanism is improvement of ventilation: perfusion mismatch through redistribution of ventilation to the dorsal part of the lungs where perfusion is prominent. Electrical impedance tomography (EIT) is a non-invasive functional lung imaging of distribution of ventilation. Therefore, we aim to assess EIT on lung ventilation inhomogeneity during supine and prone position in COVID-19 patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

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

  • more than 18 Years (Adult, Older Adult)
  • Confirmed COVID-19 (positive SARS-CoV-2 RT-PCR at nasopharyngeal swab)
  • Acute respiratory failure with 100 < PaO2:FiO2< 300 mmhg
  • Spontaneous ventilation with standard oxygen supply or high flow humidified oxygen
  • Written informed consent of the patient

排除标准

  • Contra-indication to prone position including pregnancy
  • Presence of pacemaker
  • Severe hypoxemia with PaO2/FiO2 < 100 mmHg
  • Evidence of clinical signs of respiratory distress with high probability of intubation in the next two hours

研究组 & 干预措施

patients in prone position followed by dorsal decubitus

Other

patients will be randomized on the order of position, either supine then prone, either prone then supine. Each period will last at least 2 hours.

干预措施: physiological effects of awake prone position in COVID 19 patients (Other)

dorsal decubitus followed by prone decubitus

Other

patients will be randomized on the order of position, either supine then prone, either prone then supine. Each period will last at least 2 hours.

干预措施: physiological effects of awake prone position in COVID 19 patients (Other)

结局指标

主要结局

Global Inhomogeneity Index variations (expressed in percentage) between baseline, supine and prone position periods.

时间窗: 2hours

Electrical Impedance Tomography (EIT)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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