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临床试验/NCT02240225
NCT02240225Unknown不适用

Validation of Chinese Severe Respiratory Insufficiency (SRI)Questionnaire for COPD Patients With Chronic Hypercapnic Respiratory Failure

Guangzhou Institute of Respiratory Disease1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
Reliability of Severe Respiratory Insufficiency Questionnaire

研究概览

简要总结

Assessment of health-related quality of life in COPD patients with severe chronic respiratory failure requires appropriate and highly specific measurement tools. We attempt to validate the Chinese version of the Severe Respiratory Insufficiency Questionnaire (SRI)

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

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

入选标准

  • Adult COPD Patients with chronic hypercapnic respiratory failure established on home noninvasive ventilation for at least 1 month
  • Patients are in a clinically stable state,without any changes of medication during the previous 4 weeks.

排除标准

  • patient's refusal to participate
  • Patients with evidence of acute respiratory failure i.e.patients with worsening of symptoms during the previous 2 weeks, a pH ,7.35, or with signs of respiratory infection

结局指标

主要结局

Reliability of Severe Respiratory Insufficiency Questionnaire

时间窗: 2 weeks

次要结局

  • Criterion validity of Severe Respiratory Insufficiency Questionnaire(2 weeks)
  • Construct validity of Severe Respiratory Insufficiency Questionnaire(2 weeks)

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

LuQian Zhou

Assistant professor of Guangzhou Institute of Respiratory Disease

Guangzhou Institute of Respiratory Disease

研究点 (1)

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