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临床试验/NCT04922814
NCT04922814已完成不适用

Comparison for the Effect of Neuromuscular Blocking Agents Versus Sedation Alone on Severe ARDS Patients Due to COVID-19

Assiut University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
PaO2/FiO2

研究概览

简要总结

Many questions about management of COVID-19 are still not answered. So, we recruit this study aiming to evaluate improvement of oxygenation in COVID-19 patients with severe ARDS, to improve morbidity and mortality of ICU covid patients, to participate in understanding of real hidden pathophysiology of COVID-19.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Severe ARDS: PaO2/FiO2 <200, resistant hypoxemia and tachypnoea (RR > 40 breath/minute)
  • Not relieved by high frequency nasal canula or CPAP.
  • Need for invasive mechanical ventilation (uncooperative)

排除标准

  • Patient relatives' refusal
  • Not mechanically ventilated.
  • Combination of female, corticosteroids administration and vecuronium muscle relaxant.
  • Neuromuscular diseases (especially demyelinating diseases).

研究组 & 干预措施

Muscle relaxant group(group B)

Experimental

They will receive muscle relaxation treatment for at least 48 hours. Cisatracurium will be given. Short term infusions up to 24 hours will be given in a dose rate of 2-3 mic/Kg/min followed by intervallic shots of 2-5 mg.

干预措施: muscle relaxation (Drug)

结局指标

主要结局

PaO2/FiO2

时间窗: 48 hours

ratio of arterial oxygen pressure in millilitre mercury to fraction of inspired oxygen at same time within the arterial blood gas

次要结局

  • Change in lung mechanics(48 hours)
  • SOFA score(48 hours)
  • Measurement of tissue perfusion(48 hours)
  • 28 days survival(after 28 days)
  • Recording risk factors(28 days)
  • Monitoring of Alveolar - Arterial Oxygen difference(48 hours)
  • Recording complications(28 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayman Abd El-Khalek Mohammed Glala

Principle investigator

Assiut University

研究点 (1)

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