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临床试验/NCT02804243
NCT02804243已完成不适用

The Efficacy of Nasal High Flow Oxygen Therapy With Rehabilitation in the Patients With Chronic Respiratory Failure

National Hospital Organization Minami Kyoto Hospital2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
2
主要终点
Walk distance (measured by six minutes walking test)

研究概览

简要总结

The purpose of this study is to compare the exercise endurance between oxygen therapy with rehabilitation and nasal high flow therapy with rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.

详细描述

In patients with chronic respiratory failure, pulmonary rehabilitation is recognized as an evidence-based treatment in improving exercise capacity, muscle strength, dyspnea, and quality of life. Oxygen supplementation during exercise induced dose-dependent improvement in endurance and symptom perception in chronic obstructive pulmonary disease patients. Recently, nasal high flow therapy which consists of high flow gas with an FiO2 ranging from 0.21 to nearly 1.0 adjusted by an oxygen blender, brought to body temperature, and saturated with water through an in-line humidifier is available.

The present study is randomised to compare the effect of exercise endurance between oxygen therapy with rehabilitation and nasal high flow therapy with rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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 chronic respiratory failure receiving long-term oxygen therapy for more than 3 months.

排除标准

  • Subjects with severe cardiovascular disease, diabetes, neurological disease, and renal failure.
  • Subject who are unable to undergo rehabilitation.

研究组 & 干预措施

nasal high flow therapy

Active Comparator

In this group, patients have undergone rehabilitation under the nasal high flow therapy (FiO2 100%, oxygen flow from 30 to 60 L/min) during four weeks.

干预措施: nasal high flow therapy (Device)

oxygen therapy

No Intervention

In this group, patients have undergone rehabilitation under the oxygen therapy via a nasal canula (6 L/min) during four weeks.

结局指标

主要结局

Walk distance (measured by six minutes walking test)

时间窗: Four weeks

次要结局

  • Six minutes walking test (minimum Oxygen Saturation of Arterial Blood Measured by Pulse Oximeter (SpO2) et.)(Four weeks)
  • Nutritional status (body mass index(kg/m2) et.)(Four weeks)
  • Exercise tolerance test (exercise time et.)(Four weeks)
  • Inflammation (CRP et.)(Four weeks)
  • Sympathetic activity (Catecholamine et.)(Four weeks)
  • Dyspnea (Modified Borg scale)(Four weeks)
  • Body composition measured by InBody (muscle mass et.)(Four weeks)
  • Arterial blood gas(Four 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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