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临床试验/NCT07129707
NCT07129707已完成不适用

Does Nasal High-flow Oxygen Potentiate the Effects of Rehabilitative Exercise Training in Chronic Fibrotic Interstitial Lung Disease?

Dieulefit Santé Centre de Réadaptation1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年12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
15
试验地点
1
主要终点
Time to exercise intolerance

研究概览

简要总结

Hallmarks of fibrotic interstitial lung disease (f-ILD) include severe hypoxemia, dyspnea and exercise limitation. Although ambulatory oxygen (O2) therapy is widely prescribed, standard low-flow O2 systems (nasal prongs) fail to meet patients' inspiratory demand on exertion resulting in incomplete correction of hypoxemia and limited symptomatic relief. Nasal high-flow O2 therapy (NHFO2) delivers heated, humidified, and O2-enriched air at high flow rates. It has recently emerged as a promising alternative to overcome the pre-specified limitations: NHFO2 is more effective in correcting hypoxemia and reducing dyspnea vs standard O2 therapy and consistently improved exercise capacity in f-ILD. In fact, NHF per se may exert independent physiological benefits such as washout of the anatomical dead space and reduced work of breathing. However, the respective effect of respiratory support and improved oxygenation on dyspnea and exercise tolerance remain unexplored in f-ILD. To address this gap in knowledge, this prospective, randomized-controlled trial aimed to disentangle the i) independent and ii) combined effects of respiratory support and supplemental O2 on dyspnea and exercise tolerance in patients with f-ILD.

研究设计

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

入排标准

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

入选标准

  • •diagnosis of fibrotic interstitial lung disease (regardless of etiology)
  • •age ≥18 years
  • •modified Medical Research Council scale ≥1
  • •stable condition (no acute exacerbation within the preceding 3 months)

排除标准

  • •inability to perform a cardiopulmonary exercise test (CPET) on a bicycle ergometer
  • •participation in a pulmonary rehabilitation program within the last 6 months

研究组 & 干预措施

Room Air

Placebo Comparator

Room Air breathing (flow= 0 L/min; inspired fraction of O2= 0.21)

干预措施: Exercise testing (Other)

Supplemental Oxygen

Active Comparator

Supplemental oxygen therapy (flow= 9-12 L/min; inspired fraction of O2= 1.0)

干预措施: Exercise testing (Other)

Nasal high-flow

Active Comparator

Nasal high-flow (flow= 50-70 L/min; inspired fraction of O2= 0.21)

干预措施: Exercise testing (Other)

Nasal high-flow oxygen therapy

Active Comparator

Nasal high-flow oxygen therapy (flow= 50-70 L/min; inspired fraction of O2= 0.50)

干预措施: Exercise testing (Other)

结局指标

主要结局

Time to exercise intolerance

时间窗: 4 times over 2 consecutive days (1 time per experimental condition)

Measured during a constant work-rate exercise test (70% peak work rate)

Isotime dyspnea

时间窗: 4 times over 2 consecutive days (1 time per experimental condition)

0-10 category-ratio Borg scale

次要结局

  • Breathing pattern(4 times over 2 consecutive days (1 time per experimental condition))
  • Gas exchange(4 times over 2 consecutive days (1 time per experimental condition))
  • Quadriceps muscle oxygenation(4 times over 2 consecutive days (1 time per experimental condition))

研究者

发起方
Dieulefit Santé Centre de Réadaptation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Frédéric Hérengt

Principal Investigator

Dieulefit Santé Centre de Réadaptation

研究点 (1)

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