跳至主要内容
临床试验/NCT03772626
NCT03772626Unknown不适用

The Feasibility and Efficacy of Heated Humidified Nasal Cannula (AIRVOTM) in Hospital and at Home - An Open-Label, Non-Randomized Pilot Study.

McMaster University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年2月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
ER use or hospitalization for COPD

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) is a chronic lung disease usually caused by exposure to tobacco smoke which leads to chronic symptoms of shortness of breath, cough, and phlegm. COPD is one of the leading causes of disability and death in Canada. Individuals with COPD often have periodic worsening of their disease, called exacerbations, consisting of increased shortness of breath and often an increase in cough and phlegm. These exacerbations often lead to hospital admission and are associated with worsening symptoms and lung function over time. After an exacerbation individuals with COPD usually take several weeks to return to their previous state of health and many people with an exacerbation who are discharged from hospital return to the ER within 60. Heated humidified air has been shown to improve the clearance of mucous in the lungs for people with chronic lung disease. By providing patients at St. Joseph's Hospital who are discharged after a COPD exacerbation with a device for delivering heated high humidity air to use overnight it is hoped that these individuals will be able to more easily keep their lungs and airways free of mucous. This in turn may lead to improvement in their symptoms of shortness of breath, cough, and phlegm production as well as decreasing obstruction of the airways to reduce the risk of having to return to the emergency room or hospital.

详细描述

COPD is a respiratory condition that is often associated with cigarette smoking, and defined by incompletely reversible airflow obstruction and complicated by exacerbations. Mucous hypersecretion with impaired mucociliary transport are frequently present, and are associated with infective AECOPD, and death related to pulmonary infection. COPD is both common, affecting 1 in 6 Canadians, and burdensome, being the 4th leading cause of death, in the Canadian population.

In Canada, the most common primary diagnosis associated with admission to hospital is acute exacerbation of COPD (AECOPD). For moderate to severe COPD, the average patient will have more than 2 AECOPD per year. A single episode conveys a poor prognosis, being associated with death, further AECOPD events, and reduced health-related quality of life. Despite multiple guideline-based management strategies, 1 in 3 patients with AECOPD will have another episode within 8 weeks.

Although the technology for heated humidified high-flow nasal cannula (HFNC) has been available for two decades, it has only recently become widely available for adults. The rapid humidification of gas allows this system to achieve flow rates of up to 60 liters per minute. These two factors, in combination, allow for a higher achieved fraction of inspired oxygen, and benefit the expectoration of secretions and ventilatory efficiency. Randomised clinical trials of ICU patients have demonstrated that HFNC is non-inferior to non-invasive ventilation both in the setting of acute hypoxemic respiratory failure and as an adjunct therapy post-extubation.

HFNC is a promising treatment for patients with COPD as it can counteract potentially harmful mucous abnormalities by reducing mucous viscosity and restoring mucociliary transport. Randomised studies have also demonstrated that HFNC administered at home results in an increased the time to first exacerbation, fewer AECOPD, improved quality-of-life, and reduced PaCO2. However, the efficacy of HFNC during hospital admission, when mucous abnormalities and poor expectoration could be most pronounced, has not yet been studied. Furthermore, the feasibility and efficacy of this device as a patient transitions from the hospital to the community after an AECOPD remains to be elucidated.

The objectives of this study are to test the efficacy of a heated humidified high-flow nasal cannula used during and after a hospital admission for AECOPD to reduce the risk of return to ER or readmission, and the feasibility of implementing such a device starting in hospital with transition to the home environment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Admitted to Hospital with a primary diagnosis of exacerbation of COPD
  • Greater then or equal to 20 pack year history of smoking
  • Participating in Integrated Comprehensive Care (ICC) home care program

排除标准

  • Requirement for acute non-invasive ventilation in hospital
  • Use of nocturnal non-invasive ventilation prior to hospitalization

结局指标

主要结局

ER use or hospitalization for COPD

时间窗: Length of study participation (60 days after hospital discharge)

ER visits or hospital admissions for COPD during the 60 day treatment period

次要结局

  • Use of home-care resources(Length of study participation (60 days after hospital discharge))
  • Hospital length of stay(Collected throughout inpatient enrollment period until last enrolled patient discharged (Expected total of 70 days))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joshua Wald

Assistant Professor Department of Medicine

McMaster University

研究点 (2)

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