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临床试验/NCT04787666
NCT04787666已完成不适用

Comparison of Non-invasive Methods of Lung Ventilation in Patients With Respiratory Failure in the Postoperative Period After Cardiac Surgery

Petrovsky National Research Centre of Surgery1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年3月3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
90
试验地点
1
主要终点
PaO2/FiO2 more than 300

研究概览

简要总结

Comparison of the effectiveness of three methods of non-invasive ventilation in patients with mild and moderate respiratory failure in the early postoperative period after cardiac surgery

详细描述

The study includes the comparison of the three methods of non-invasive ventilation: non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet in patients with mild and moderate respiratory failure in the early postoperative period after cardiac surgery. It assumes 90 randomized patients:30 patients in three study groups male and female aged 30 to 60 years of age inclusive, with mild or moderate respiratory failure.The study will be randomized, single-center, prospective.

研究设计

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

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 30 years to 60 years inclusive
  • Decreased oxygenation function of the lungs (SpO2 less than 90%, PaO2/FiO2 less than 300, BH less than 25 per minute)
  • By data CT/x-ray examination of hypoventilation zones (pneumonia, atelectasis)
  • Consent the patient to participate in this study

排除标准

  • Tracheal intubation, absence of independent breathing
  • Unstable hemodynamics or hemodynamically significant rhythm disturbances
  • Acute violation of the cerebral blood supply
  • Shocks of various etiologies
  • Impossibility provide respiratory protection , high risk of aspiration
  • Lack of productive contact with the patient
  • Patient's refusal to participate in this study

结局指标

主要结局

PaO2/FiO2 more than 300

时间窗: hospitalisation period, an average of 1 week

Comparison of PaO2/FiO2 before/after research

次要结局

  • maximum inspiratory volume(hospitalisation period, an average of 1 week)
  • arterial blood oxygenation level(hospitalisation period, an average of 1 week)

研究者

发起方
Petrovsky National Research Centre of Surgery
申办方类型
Other
责任方
Principal Investigator
主要研究者

Darya Ryabova, research worker

Russian national research center of surgery named after academian B. V. Petrovsky

Petrovsky National Research Centre of Surgery

研究点 (1)

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