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临床试验/NCT06620081
NCT06620081已完成不适用

Effects of High-Flow Nasal Cannula on Exercise Outcomes in Lung Transplant Candidates: A Pilot Study

Hospital Israelita Albert Einstein2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年6月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Evaluate the effect of HFNC on the distance covered in the 6MWT

研究概览

简要总结

The study evaluated patients on the national lung transplant waiting list. It was pioneering in assessing high-complexity patients with severe pulmonary diseases subjected to a cardiopulmonary rehabilitation protocol using a treadmill. The main findings indicate that the distance covered in the six-minute walk test was greater when using the high-flow nasal cannula supplementation. The improvement in exercise performance in this group is associated with a reduction in arterial carbon dioxide, optimization of hydrogen potential, and a decrease in dynamic hyperinflation, leading to fewer symptoms of dyspnea.

详细描述

Introduction

Pulmonary diseases have a significant global prevalence, and lung transplantation is indicated for advanced cases. Rehabilitation is essential for patients on the waiting list and requires ventilatory devices for symptom control during exertion. The high-flow nasal cannula is a promising alternative, but its effects on exercise outcomes are uncertain. Objectives: To assess the effects of high-flow nasal cannula on the outcomes of the six-minute walk test. Method: A randomized crossover clinical trial evaluated ten volunteers listed on the national lung transplant waiting list. Three functional tests were performed: the six-minute walk test, incremental lower limb test with arterial blood gas analysis, and lower limb endurance test with inspiratory capacity measurement. Each test was conducted on different days with different devices: high-flow nasal cannula and conventional oxygen therapy, totaling six test days. The inspired oxygen fraction was titrated to maintain normoxia between 90% to 96% and was kept constant for both interfaces.

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
None

入排标准

年龄范围
30 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteers of both sexes
  • Patients on the national lung transplant waiting list
  • Chronic obstructive pulmonary disease
  • Idiopathic or familial pulmonary fibrosis
  • Bronchiectasis
  • Sarcoidosis

排除标准

  • Osteoarticular limitation,
  • Neuromuscular disease,
  • Hyperglycemia
  • Arrhythmia
  • Left heart failure
  • Pulmonary hypertension

结局指标

主要结局

Evaluate the effect of HFNC on the distance covered in the 6MWT

时间窗: 24 months

Assessment of the distance traveled in 6 minutes.

Effect of HFNC on CO2 kinetics.

时间窗: 24 months

Assessment of the kinetics of effort-induced carbon dioxide.

Investigate the effect of HFNC on exercise-induced dynamic hyperinflation in patients on the lung transplant waiting list participating in a cardiopulmonary rehabilitation program.

时间窗: 24 months

Assessment of high-flow therapy in effort-induced hyperinflation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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