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临床试验/NCT04054622
NCT04054622Unknown不适用

Patient-ventilator Asychrony During Non-invasive Ventilation When COPD Patients Doing Exercise

Guangzhou Medical University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
10
试验地点
1
主要终点
Asynchrony index

研究概览

简要总结

Pulmonary rehabilitation programmes including aerobic exercise training have strong evidence of effectiveness in improving exercise capacity, dyspnoea and HRQL in patients with COPD. Therefore, current guidelines recommend pulmonary rehabilitation, including exercise training, in these patients. Non-invasive ventilation(NIV) is increasingly used during exercise training programmes in order to train patients at intensity levels higher than allowed by their clinical and pathophysiological conditions. Patient-ventilator asynchrony (PVA) describes the poor interaction between the patient and the ventilator and is the consequence of the respiratory muscle activity of the patient being opposed to the action of the ventilator.PVA have unfavourable clinical impace on gas exchange, dyspnoea perception, patient comfort and tolerance and reduced adherence to NIV. This study is going to detect whether the PVA will increase when COPD patients exercise with NIV supporingt

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 40-80, males and females;
  • Stage III and IV COPD;
  • Similar with non-invasive ventilation;
  • Willing to participate in the study;
  • Able to provide informed consent.

排除标准

  • Presented with an acute exacerbation during previous 3 months;
  • Bronchiectasis; post-tuberculosis sequelae; rib cage deformities; neuromuscular disorders; and bronchial carcinoma.
  • Intolerant with NIV

结局指标

主要结局

Asynchrony index

时间窗: 5 hours

Asynchrony index is defined as the number of asynchrony events divided by the total respiratory rate computed as the sum of the number of ventilator cycles (triggered or not) and of wasted efforts: asynchrony Index (expressed in percentage) = number of asynchrony events/total respiratory rate (ventilator cycles +wasted efforts) × 100

次要结局

  • Partial pressure of arterial blood carbon dioxide (PaCO2)(5 hours)
  • COPD assessment test(5 hours)
  • 6-minute walk test(5 hours)
  • Severe Respiratory Insufficiency (SRI) Questionnaire(5 hours)

研究者

发起方
Guangzhou Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhenfeng He

Principle investigator

Guangzhou Medical University

研究点 (1)

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