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临床试验/NCT05706467
NCT05706467尚未招募不适用

The Difference Between Non-invasive High-frequency Oscillatory Ventilation and Non-invasive Continuous Airway Pressure Ventilation in COVID-19 With Acute Hypoxemia

Guangzhou Institute of Respiratory Disease0 个研究点目标入组 20 人开始时间: 2023年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
主要终点
ROX index

研究概览

简要总结

High frequency oscillatory ventilation (HFOV), as an ideal lung protection ventilation method, has been gradually applied to neonatal intensive care treatment, and is currently recommended as a rescue method for neonatal acute respiratory distress syndrome (ARDS) after failure of conventional mechanical ventilation. Although its ability to improve oxygenation and enhance carbon dioxide (CO2) clearance has been repeatedly demonstrated in laboratory studies, its impact on the clinical results of these patients is still uncertain. Noninvasive high-frequency oscillatory ventilation (nHFOV) combines the advantages of HFOV and non-invasive ventilation, and has become the current research focus in this field. It is recommended to use it after the failure of routine non-invasive ventilation treatment to avoid intubation. For the treatment of intubation, there is still a lack of large-scale clinical trials to systematically explore its efficacy. The gradual increase of clinical application of nHFOV has also enriched its application in the treatment of other diseases. At present, non-invasive high-frequency oscillatory ventilation has not been applied to the study of adult COVID-19 with acute hypoxemia, which will be the first study in this field.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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

  • After COVID-19 nucleic acid detection, imaging confirmed COVID-19;
  • Age ≥ 18 years old;
  • At the time of admission, the blood gas was acute hypoxic respiratory failure, the fraction of inhaled oxygen concentration (Fio2) was at least 0.40, but the blood oxygen saturation (Spo2) was 94% or lower;
  • Be able to follow the instructions of the researcher.

排除标准

  • Critically ill patients: cardiac and respiratory arrest, requiring tracheal intubation; Multiple organ failure (>2 organs);
  • Hemodynamic instability;
  • After extubation of invasive mechanical ventilation;
  • Patients who cannot wear a mask, such as maxillofacial or upper airway surgery;
  • Patients who may affect the treatment effect of NPPV, such as nasal obstruction or upper respiratory tract obstruction;
  • Obvious bullae, pneumothorax and pleural effusion;
  • It is accompanied by obvious other respiratory diseases, such as bronchiectasis and lung cancer;
  • Those who refuse to participate in this test.

结局指标

主要结局

ROX index

时间窗: 30 minutes

(SpO2/FiO2)/RR

次要结局

  • Asynchrony index(30 minutes)

研究者

发起方
Guangzhou Institute of Respiratory Disease
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jianyi Niu

Principle investigator

Guangzhou Institute of Respiratory Disease

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