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临床试验/NCT04471220
NCT04471220已完成不适用

Examination of Exercise Capacity Under Various Oxygen Concentrations and Oxygen Flow Rates Using High Flow Nasal Cannula

National Hospital Organization Minami Kyoto Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年7月1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
50
试验地点
2
主要终点
Difference in 6MWD between two conditions ("Low FIO2 and high flow rate" and "High FIO2 and high flow rate")

研究概览

简要总结

The purpose of this study is to compare the exercise capacity (6-min walking distance) under the following 4 conditions using High-flow nasal cannula (HFNC); 1. FIO2 value that the minimum SpO2 value in a 6-minute walking test (6MWT) is 86-88%, and a flow of 10 L/min 2. FIO2 value that the minimum SpO2 value in a 6MWT is 86-88%, and a flow of 40-50 L/min 3. FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 10 L/min 4. FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 40-50 L/min

详细描述

In the pervious study, the investigators demonstrated that 4 weeks of training using both high FIO2 and high flow through an HFNC significantly improved the 6MWD compared with training using a 6 L/min nasal cannula. However, it was unclear whether the effects of pulmonary rehabilitation under HFNC were due to high FIO2, high flow rate, or a synergistic effect. It is also unknown whether there are differences in the effects of pulmonary rehabilitation under HFNC for each underlying disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects with a minimum SPO2 of 88% or less during performing 6MWT under HFNC (FIO2 0.21 and a flow rate of 10L/min)
  • Subjects who have been clinically stable for the last 2 weeks
  • Subjects with written informed consent to participate in this study

排除标准

  • Subjects with severe cardiovascular disease, liver disease, neurological disease, and renal failure
  • Subjects who needed antimicrobial agent or steroid administration for pneumonia and exacerbation of respiratory disease in the last 2 weeks
  • Subjects who cannot undergo 6MWT due to severe heart failure, arteriosclerosis obliterans or spinal disease

结局指标

主要结局

Difference in 6MWD between two conditions ("Low FIO2 and high flow rate" and "High FIO2 and high flow rate")

时间窗: through study completion, an average of 2 weeks

次要结局

  • Difference in Dyspnea during 6MWT between four conditions(through study completion, an average of 2 weeks)
  • Difference in SpO2 value during 6MWT between four conditions(through study completion, an average of 2 weeks)
  • Difference in Pulse rate value during 6MWT between four conditions(through study completion, an average of 2 weeks)
  • Difference in lower limb fatigue during 6MWT between four conditions(through study completion, an average of 2 weeks)
  • Difference in 6MWD between four conditions(through study completion, an average of 2 weeks)

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 (2)

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