The Efficacy of the AIRVO Warm Humidifier as an Add on to Oxygen Therapy as Well as Stand-alone Therapy in Patients With Respiratory Insufficiency
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in the number of COPD medication therapy changes compared to baseline at 12 months.
研究概览
简要总结
The primary purpose of this study is to show whether at home usage of the AIRVO warm humidifier can potentially reduce the number of exacerbations in patients with significant respiratory insufficiency. Eligible participants of the study must have a diagnosis of chronic obstructive pulmonary disease (COPD) stage II-IV..
详细描述
SPECIFIC AIMS/OBJECTIVES To determine whether the patients with chronic respiratory sufficiency can benefit from the AIRVO warm humidifier by decreasing the number of exacerbations. Furthermore, to determine the efficacy of warm humidification oxygen therapy compared to dry oxygen therapy, in short-term and long-term treatment of patients with stage II-IV COPD.
Primary Objective:
To observer and compare the exacerbation frequency between the warm humidification oxygen therapy group and dry oxygen therapy group.
Secondary Objective:
Compare the number of exacerbation days, median time to first exacerbation, hospital readmissions, and antibiotic use pertaining to respiratory infections with the baseline values. Evaluate and compare the quality of life to the baseline measurements.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have stage II-IV COPD diagnosis Understand and accept oral and written information in English Be capable of handling the AIRVO warm humidifier after instruction >18years of age
排除标准
- •Comorbidity (known malignant disease, terminal illness, dementia, uncontrolled mental illness)
- •Bronchiectasis without simultaneous COPD diagnosis
- •Treatment with BiPAP in the home
- •Affected level of consciousness
- •Smoking status change during study period
- •Inability to provided signed consent
结局指标
主要结局
Change in the number of COPD medication therapy changes compared to baseline at 12 months.
时间窗: baseline, 12 months
The change in number of hospitalizations warm humidification oxygen therapy and dry oxygen therapy.
时间窗: baseline, 12 months
The change in number of hospitalizations compared to baseline data at 12 months.
Change in the number of courses of antibiotic therapy compared to baseline data at 12 months
时间窗: baseline, 12 months
Change in the number of courses of corticosteroid therapy compared to baseline data at 12 months.
时间窗: baseline, 12 months
次要结局
- The change in distance walked during a 6 minute walk test between humidification oxygen therapy and dry oxygen therapy at baseline, and 12 months.(baseline, 12 months)
- Change in Spirometry measured pulmonary function between humidification oxygen therapy and dry oxygen therapy at baseline, and 12 months.(baseline, 12 months)
- The change in the quality of life scores as measured by the Ferrans and Powers quality of life Index Pulmonary version III between humidification oxygen therapy and dry oxygen therapy at baseline, and 12 months.(baseline, 12 months)
研究者
Eustice Fernandes MD
Principal Investigator
Lutheran Hospital, Indiana