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临床试验/NCT05188976
NCT05188976招募中不适用

Validity Assessment of End-tidal Carbon Dioxide Levels in Respiratory Disease

National Hospital Organization Minami Kyoto Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Correlation between PetCO2, PaCO2, and PtcCO2

研究概览

简要总结

The investigators aim to evaluate the correlation between PetCO2, PaCO2, and PtcCO2 in patients with respiratory diseases. The investigators also evaluate the correlation between PetCO2, PaCO2, and PtcCO2 changes over time.

详细描述

Partial pressure of carbon dioxide(PCO2) is mainly evaluated by partial pressure of arterial carbon dioxide (PaCO2), and is used as an index for prognosis and NPPV introduction in chronic respiratory failure. Arterial blood gas analysis for PaCO2 measurement is the most accurate test value, but it is invasive and frequent tests are difficult and cannot be performed at home. The transcutaneous PCO2 (PtcCO2) is a non-invasive measurement and its measured value is close to PaCO2, and it can be measured continuously, which is useful for monitoring patients with chronic respiratory failure. However, PtcCo2 has not been applied at home due to technical problems (necessity of calibration, periodic drift, etc.). The end-tidal pressure of expired CO2 (PetCO2) can be measured non-invasively, easily and continuously. PetCO2 is mainly used for patients undergoing mechanical ventilation, and its accuracy and stability have been evaluated. The investigators decided to investigate whether PetCO2 is useful for monitoring respiratory status in patients with respiratory disorder.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Subjects with respiratory disorder.
  • Subjects who are clinically stable for the last 2 weeks

排除标准

  • Subjects who required treatment with antibacterial agents or oral/intravenous steroids for pneumonia or exacerbation of respiratory disease in the last 2 weeks.
  • Subjects with severe complications such as cardiovascular disease, liver disease, renal disease, and neurological disease.

结局指标

主要结局

Correlation between PetCO2, PaCO2, and PtcCO2

时间窗: One to three months

次要结局

  • Relationship between PetCO2 and respiratory symptoms evaluated by The COPD Assessment Test (CAT) and mMRC (modified British Medical Research Council)(One to three months)
  • Correlation of changes over time between PetCO2, PaCO2 , and PtcCO2(One to three months)

研究者

发起方
National Hospital Organization Minami Kyoto Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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